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Ignite Creation Date: 2025-12-24 @ 5:26 PM

Ignite Modification Date: 2026-02-25 @ 2:36 AM

Study NCT ID: NCT02720068

Status: COMPLETED

Last Update Posted: 2025-05-30

First Post: 2016-03-22

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001)

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'China', 'Germany', 'Israel', 'Japan', 'Poland', 'South Korea', 'Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'C531958', 'term': 'lenvatinib'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 92 months', 'description': 'AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" \\& "Disease progression" without hospitalization/death are excluded.\n\nParticipants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 4, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 21, 'otherNumAffected': 18, 'seriousNumAtRisk': 20, 'deathsNumAffected': 11, 'seriousNumAffected': 3}, {'id': 'EG011', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 206, 'otherNumAffected': 185, 'seriousNumAtRisk': 205, 'deathsNumAffected': 172, 'seriousNumAffected': 69}, {'id': 'EG012', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 39, 'seriousNumAtRisk': 40, 'deathsNumAffected': 35, 'seriousNumAffected': 17}, {'id': 'EG013', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 40, 'seriousNumAtRisk': 41, 'deathsNumAffected': 36, 'seriousNumAffected': 12}, {'id': 'EG014', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 59, 'otherNumAffected': 54, 'seriousNumAtRisk': 58, 'deathsNumAffected': 50, 'seriousNumAffected': 20}, {'id': 'EG015', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 16, 'seriousNumAffected': 9}, {'id': 'EG016', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 20, 'seriousNumAffected': 6}, {'id': 'EG017', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'deathsNumAffected': 28, 'seriousNumAffected': 23}, {'id': 'EG018', 'title': 'Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C)', 'description': 'Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 9, 'seriousNumAffected': 1}, {'id': 'EG019', 'title': 'Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A)', 'description': 'One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 205, 'numEvents': 49, 'numAffected': 42}, {'groupId': 'EG012', 'numAtRisk': 40, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG013', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG014', 'numAtRisk': 58, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG015', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG017', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG018', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 205, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG012', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 20, 'numEvents': 36, 'numAffected': 8}, {'groupId': 'EG016', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG017', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG016', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG018', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 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'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG007', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG010', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG011', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG012', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG013', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG014', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG015', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG016', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG017', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 21 days (Cycle 1)', 'description': 'DLTs were assessed during the first cycle (21 days) \\& were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with bleeding; Gr 3 nonhematologic toxicity lasting ≥3 days despite optimal supportive care (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for \\>1 week); Gr 3 or 4 febrile neutropenia; any drug-related AE that caused the participant to discontinue treatment during Cycle 1; Grade 5 toxicity; Any treatment-related toxicity that causes ≥2-week delay in initiation of Cycle 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment prior to determination of maximum tolerated dose, and were observed for safety for 21 days after their first dose of assigned treatment or experienced a DLT prior to 21 days after their first dose of assigned treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '205', 'groupId': 'OG011'}, {'value': '40', 'groupId': 'OG012'}, {'value': '41', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '20', 'groupId': 'OG015'}, {'value': '58', 'groupId': 'OG016'}, {'value': '40', 'groupId': 'OG017'}, {'value': '9', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG007', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG010', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.'}, {'id': 'OG011', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. One participant received a second course for up to 17 cycles; any events occurring after initiating the second course were reported in a separate arm instead of this one.'}, {'id': 'OG012', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG013', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG014', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG015', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG016', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG017', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'OG018', 'title': 'Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C)', 'description': 'Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG019', 'title': 'Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A)', 'description': 'One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '19', 'groupId': 'OG010'}, {'value': '196', 'groupId': 'OG011'}, {'value': '40', 'groupId': 'OG012'}, {'value': '41', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '20', 'groupId': 'OG015'}, {'value': '55', 'groupId': 'OG016'}, {'value': '40', 'groupId': 'OG017'}, {'value': '7', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 31.3 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '205', 'groupId': 'OG011'}, {'value': '40', 'groupId': 'OG012'}, {'value': '41', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '20', 'groupId': 'OG015'}, {'value': '58', 'groupId': 'OG016'}, {'value': '40', 'groupId': 'OG017'}, {'value': '9', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG007', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG010', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.'}, {'id': 'OG011', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. One participant received a second course for up to 17 cycles; any events occurring after initiating the second course were reported in a separate arm instead of this one.'}, {'id': 'OG012', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG013', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG014', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG015', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG016', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG017', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'OG018', 'title': 'Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C)', 'description': 'Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG019', 'title': 'Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A)', 'description': 'One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '22', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '11', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 28.3 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) for Part B Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '39', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '40', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Colorectal Cancer Participants in Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants with colorectal cancer received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'HNSCC Participants in Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants with head and neck squamous cell cancer (HNSCC) received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Gastric Cancer Participants in Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants with gastric cancer received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Colorectal Cancer Participants in Part B: MK-4280A (Arm 5)', 'description': 'Participants with colorectal cancer received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG007', 'title': 'China Enrollment in Part B: MK-4280A (Arm 5)', 'description': 'Participants enrolled in China received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG009', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG010', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '16.8'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '9.5'}, {'value': '15.0', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '26.6'}, {'value': '7.5', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '20.4'}, {'value': '15.0', 'groupId': 'OG004', 'lowerLimit': '5.7', 'upperLimit': '29.8'}, {'value': '7.3', 'groupId': 'OG005', 'lowerLimit': '1.5', 'upperLimit': '19.9'}, {'value': '5.1', 'groupId': 'OG006', 'lowerLimit': '0.6', 'upperLimit': '17.3'}, {'value': '10.5', 'groupId': 'OG007', 'lowerLimit': '1.3', 'upperLimit': '33.1'}, {'value': '25.0', 'groupId': 'OG008', 'lowerLimit': '8.7', 'upperLimit': '49.1'}, {'value': '0.0', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '16.8'}, {'value': '7.5', 'groupId': 'OG010', 'lowerLimit': '1.6', 'upperLimit': '20.4'}]}]}], 'analyses': [{'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.5', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '22.9', 'estimateComment': 'Confidence interval based on Miettinen \\& Nurminen method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in Percentage'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 92 months', 'description': 'ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced a CR or PR is presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in Part B with a baseline scan with measurable disease by investigator assessment, who received ≥1 dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '187', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '184', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '188', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '40', 'groupId': 'OG019'}, {'value': '40', 'groupId': 'OG020'}, {'value': '20', 'groupId': 'OG021'}, {'value': '33', 'groupId': 'OG022'}, {'value': '20', 'groupId': 'OG023'}, {'value': '54', 'groupId': 'OG024'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Favezelimab 7 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Pooled Favezelimab 21 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Pooled Favezelimab 70 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Pooled Favezelimab 200 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Pooled Favezelimab 210 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Pooled Favezelimab 700 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Pooled Favezelimab 800 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with pembrolizumab (MK-4280A).'}, {'id': 'OG007', 'title': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG010', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG011', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG012', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG013', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG014', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG015', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG016', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG017', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG018', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG019', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG020', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG021', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG022', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'OG023', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG024', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '187', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '184', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '188', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '40', 'groupId': 'OG019'}, {'value': '40', 'groupId': 'OG020'}, {'value': '20', 'groupId': 'OG021'}, {'value': '33', 'groupId': 'OG022'}, {'value': '20', 'groupId': 'OG023'}, {'value': '54', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '7.12', 'spread': '58.8', 'groupId': 'OG000'}, {'value': '34.6', 'spread': '45.4', 'groupId': 'OG001'}, {'value': '98.8', 'spread': '42.7', 'groupId': 'OG002'}, {'value': '305', 'spread': '48.4', 'groupId': 'OG003'}, {'value': '365', 'spread': '39.8', 'groupId': 'OG004'}, {'value': '1480', 'spread': '39.6', 'groupId': 'OG005'}, {'value': '1620', 'spread': '54.7', 'groupId': 'OG006'}, {'value': '10.5', 'spread': '49', 'groupId': 'OG007'}, {'value': '37.4', 'spread': '43.3', 'groupId': 'OG008'}, {'value': '99.3', 'spread': '28.6', 'groupId': 'OG009'}, {'value': '341', 'spread': '51', 'groupId': 'OG010'}, {'value': '1590', 'spread': '21.5', 'groupId': 'OG011'}, {'value': '1820', 'spread': '46.6', 'groupId': 'OG012'}, {'value': '4.81', 'spread': '25.7', 'groupId': 'OG013'}, {'value': '21.5', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG014'}, {'value': '98.3', 'spread': '63.7', 'groupId': 'OG015'}, {'value': '305', 'spread': '48.3', 'groupId': 'OG016'}, {'value': '391', 'spread': '36.1', 'groupId': 'OG017'}, {'value': '1610', 'spread': '36.5', 'groupId': 'OG018'}, {'value': '1440', 'spread': '41.6', 'groupId': 'OG019'}, {'value': '1430', 'spread': '46.4', 'groupId': 'OG020'}, {'value': '1670', 'spread': '40.3', 'groupId': 'OG021'}, {'value': '1870', 'spread': '75.1', 'groupId': 'OG022'}, {'value': '2010', 'spread': '54.5', 'groupId': 'OG023'}, {'value': '1430', 'spread': '49.6', 'groupId': 'OG024'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '113', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '127', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '25', 'groupId': 'OG020'}, {'value': '17', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '19', 'groupId': 'OG023'}, {'value': '44', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '8.28', 'spread': '45.8', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '41.3', 'groupId': 'OG001'}, {'value': '56.0', 'spread': '179.4', 'groupId': 'OG002'}, {'value': '330', 'spread': '58.1', 'groupId': 'OG003'}, {'value': '335', 'spread': '48.5', 'groupId': 'OG004'}, {'value': '1730', 'spread': '53.1', 'groupId': 'OG005'}, {'value': '1850', 'spread': '59.2', 'groupId': 'OG006'}, {'value': '14.6', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG007'}, {'value': '33.1', 'spread': '41.3', 'groupId': 'OG008'}, {'value': '60.0', 'spread': '92.4', 'groupId': 'OG009'}, {'value': '298', 'spread': '51.6', 'groupId': 'OG010'}, {'value': '1640', 'spread': '20.5', 'groupId': 'OG011'}, {'value': '2200', 'spread': '42.8', 'groupId': 'OG012'}, {'value': '6.86', 'spread': '27.3', 'groupId': 'OG013'}, {'value': '52.2', 'spread': '429.4', 'groupId': 'OG015'}, {'value': '324', 'spread': '58.7', 'groupId': 'OG016'}, {'value': '378', 'spread': '53.1', 'groupId': 'OG017'}, {'value': '2330', 'spread': '18.4', 'groupId': 'OG018'}, {'value': '1690', 'spread': '57.4', 'groupId': 'OG019'}, {'value': '1450', 'spread': '49.9', 'groupId': 'OG020'}, {'value': '2300', 'spread': '46.6', 'groupId': 'OG021'}, {'value': '2690', 'spread': '55', 'groupId': 'OG023'}, {'value': '1580', 'spread': '61.9', 'groupId': 'OG024'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '4', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '248', 'spread': '33.6', 'groupId': 'OG003'}, {'value': '2000', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG005'}, {'value': '3880', 'spread': '16.9', 'groupId': 'OG006'}, {'value': '3880', 'spread': '16.8', 'groupId': 'OG012'}, {'value': '248', 'spread': '33.6', 'groupId': 'OG016'}, {'value': '2000', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG019'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '45', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '12', 'groupId': 'OG019'}, {'value': '6', 'groupId': 'OG020'}, {'value': '5', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '3', 'groupId': 'OG023'}, {'value': '19', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '9.38', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '79.5', 'groupId': 'OG001'}, {'value': '88.2', 'spread': '80.4', 'groupId': 'OG002'}, {'value': '329', 'spread': '71.5', 'groupId': 'OG003'}, {'value': '166', 'spread': '114.5', 'groupId': 'OG004'}, {'value': '1870', 'spread': '56.5', 'groupId': 'OG005'}, {'value': '1860', 'spread': '58.6', 'groupId': 'OG006'}, {'value': '46.1', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG009'}, {'value': '113', 'spread': '109.9', 'groupId': 'OG010'}, {'value': '2880', 'spread': '55.2', 'groupId': 'OG012'}, {'value': '9.38', 'spread': '22.3', 'groupId': 'OG013'}, {'value': '13.7', 'spread': '79.5', 'groupId': 'OG014'}, {'value': '122', 'spread': '66.4', 'groupId': 'OG015'}, {'value': '330', 'spread': '70.6', 'groupId': 'OG016'}, {'value': '357', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG017'}, {'value': '1240', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG018'}, {'value': '1940', 'spread': '57.5', 'groupId': 'OG019'}, {'value': '1570', 'spread': '40.7', 'groupId': 'OG020'}, {'value': '2370', 'spread': '44.6', 'groupId': 'OG021'}, {'value': '2070', 'spread': '73.8', 'groupId': 'OG023'}, {'value': '1640', 'spread': '62.4', 'groupId': 'OG024'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '6', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '2030', 'spread': '67.6', 'groupId': 'OG006'}, {'value': '2030', 'spread': '67.6', 'groupId': 'OG024'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.', 'unitOfMeasure': 'Day*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '188', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '191', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '40', 'groupId': 'OG019'}, {'value': '40', 'groupId': 'OG020'}, {'value': '20', 'groupId': 'OG021'}, {'value': '36', 'groupId': 'OG022'}, {'value': '20', 'groupId': 'OG023'}, {'value': '58', 'groupId': 'OG024'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Favezelimab 7 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Pooled Favezelimab 21 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Pooled Favezelimab 70 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Pooled Favezelimab 200 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Pooled Favezelimab 210 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Pooled Favezelimab 700 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Pooled Favezelimab 800 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with pembrolizumab (MK-4280A).'}, {'id': 'OG007', 'title': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG010', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG011', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG012', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG013', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG014', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG015', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG016', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG017', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG018', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG019', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG020', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG021', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG022', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'OG023', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG024', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '188', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '191', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '40', 'groupId': 'OG019'}, {'value': '40', 'groupId': 'OG020'}, {'value': '20', 'groupId': 'OG021'}, {'value': '36', 'groupId': 'OG022'}, {'value': '20', 'groupId': 'OG023'}, {'value': '58', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '7.29', 'spread': '58.4', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '41.1', 'groupId': 'OG001'}, {'value': '96.1', 'spread': '39.6', 'groupId': 'OG002'}, {'value': '285', 'spread': '42.8', 'groupId': 'OG003'}, {'value': '353', 'spread': '38.4', 'groupId': 'OG004'}, {'value': '1300', 'spread': '34.1', 'groupId': 'OG005'}, {'value': '1430', 'spread': '48.1', 'groupId': 'OG006'}, {'value': '11.0', 'spread': '38.6', 'groupId': 'OG007'}, {'value': '36.5', 'spread': '42.4', 'groupId': 'OG008'}, {'value': '97.2', 'spread': '28.5', 'groupId': 'OG009'}, {'value': '333', 'spread': '49.6', 'groupId': 'OG010'}, {'value': '1440', 'spread': '23.2', 'groupId': 'OG011'}, {'value': '1550', 'spread': '35.8', 'groupId': 'OG012'}, {'value': '4.82', 'spread': '28.5', 'groupId': 'OG013'}, {'value': '39.6', 'spread': '47.7', 'groupId': 'OG014'}, {'value': '95.0', 'spread': '57.5', 'groupId': 'OG015'}, {'value': '285', 'spread': '42.8', 'groupId': 'OG016'}, {'value': '374', 'spread': '34.9', 'groupId': 'OG017'}, {'value': '1370', 'spread': '30.0', 'groupId': 'OG018'}, {'value': '1290', 'spread': '35.5', 'groupId': 'OG019'}, {'value': '1330', 'spread': '40.5', 'groupId': 'OG020'}, {'value': '1420', 'spread': '34.8', 'groupId': 'OG021'}, {'value': '1640', 'spread': '71.9', 'groupId': 'OG022'}, {'value': '1630', 'spread': '41.6', 'groupId': 'OG023'}, {'value': '1290', 'spread': '43.7', 'groupId': 'OG024'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '133', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '120', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '133', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '30', 'groupId': 'OG019'}, {'value': '27', 'groupId': 'OG020'}, {'value': '17', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '20', 'groupId': 'OG023'}, {'value': '44', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '7.83', 'spread': '73.1', 'groupId': 'OG000'}, {'value': '32.7', 'spread': '40.1', 'groupId': 'OG001'}, {'value': '56.4', 'spread': '154.4', 'groupId': 'OG002'}, {'value': '300', 'spread': '51.4', 'groupId': 'OG003'}, {'value': '321', 'spread': '44.9', 'groupId': 'OG004'}, {'value': '1480', 'spread': '43', 'groupId': 'OG005'}, {'value': '1570', 'spread': '54.9', 'groupId': 'OG006'}, {'value': '9.32', 'spread': '184.6', 'groupId': 'OG007'}, {'value': '32.7', 'spread': '40.1', 'groupId': 'OG008'}, {'value': '59.3', 'spread': '88.6', 'groupId': 'OG009'}, {'value': '292', 'spread': '48.3', 'groupId': 'OG010'}, {'value': '1470', 'spread': '15.7', 'groupId': 'OG011'}, {'value': '2140', 'spread': '40.9', 'groupId': 'OG012'}, {'value': '6.97', 'spread': '25.7', 'groupId': 'OG013'}, {'value': '53.7', 'spread': '327.1', 'groupId': 'OG015'}, {'value': '300', 'spread': '51.4', 'groupId': 'OG016'}, {'value': '353', 'spread': '49.8', 'groupId': 'OG017'}, {'value': '1640', 'spread': '38.7', 'groupId': 'OG018'}, {'value': '1460', 'spread': '46', 'groupId': 'OG019'}, {'value': '1260', 'spread': '65.1', 'groupId': 'OG020'}, {'value': '1820', 'spread': '37.2', 'groupId': 'OG021'}, {'value': '2050', 'spread': '43.6', 'groupId': 'OG023'}, {'value': '1400', 'spread': '51.9', 'groupId': 'OG024'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '241', 'spread': '26.4', 'groupId': 'OG003'}, {'value': '1770', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG005'}, {'value': '2330', 'spread': '51.5', 'groupId': 'OG006'}, {'value': '2330', 'spread': '51.5', 'groupId': 'OG012'}, {'value': '241', 'spread': '26.4', 'groupId': 'OG016'}, {'value': '1770', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG019'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '45', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '12', 'groupId': 'OG019'}, {'value': '6', 'groupId': 'OG020'}, {'value': '5', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '4', 'groupId': 'OG023'}, {'value': '19', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '9.57', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '81', 'groupId': 'OG001'}, {'value': '89.6', 'spread': '65', 'groupId': 'OG002'}, {'value': '306', 'spread': '63.4', 'groupId': 'OG003'}, {'value': '174', 'spread': '91', 'groupId': 'OG004'}, {'value': '1620', 'spread': '44.2', 'groupId': 'OG005'}, {'value': '1710', 'spread': '53.6', 'groupId': 'OG006'}, {'value': '53.1', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG009'}, {'value': '124', 'spread': '83.4', 'groupId': 'OG010'}, {'value': '2320', 'spread': '34.6', 'groupId': 'OG012'}, {'value': '9.57', 'spread': '21.9', 'groupId': 'OG013'}, {'value': '13.8', 'spread': '81', 'groupId': 'OG014'}, {'value': '116', 'spread': '58.6', 'groupId': 'OG015'}, {'value': '306', 'spread': '63.4', 'groupId': 'OG016'}, {'value': '341', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG017'}, {'value': '1120', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG018'}, {'value': '1670', 'spread': '44.6', 'groupId': 'OG019'}, {'value': '1500', 'spread': '37.7', 'groupId': 'OG020'}, {'value': '2070', 'spread': '40.4', 'groupId': 'OG021'}, {'value': '2330', 'spread': '90.1', 'groupId': 'OG023'}, {'value': '1490', 'spread': '53.7', 'groupId': 'OG024'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '6', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '1730', 'spread': '51.8', 'groupId': 'OG006'}, {'value': '1730', 'spread': '51.8', 'groupId': 'OG024'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.', 'unitOfMeasure': 'Day*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration (Cmax) of Favezelimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '195', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '203', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '40', 'groupId': 'OG019'}, {'value': '41', 'groupId': 'OG020'}, {'value': '20', 'groupId': 'OG021'}, {'value': '38', 'groupId': 'OG022'}, {'value': '20', 'groupId': 'OG023'}, {'value': '58', 'groupId': 'OG024'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Favezelimab 7 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Pooled Favezelimab 21 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Pooled Favezelimab 70 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Pooled Favezelimab 200 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Pooled Favezelimab 210 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Pooled Favezelimab 700 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Pooled Favezelimab 800 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with pembrolizumab (MK-4280A).'}, {'id': 'OG007', 'title': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG010', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG011', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG012', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG013', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG014', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG015', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG016', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG017', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG018', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG019', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG020', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG021', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG022', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'OG023', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG024', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '195', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '203', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '40', 'groupId': 'OG019'}, {'value': '41', 'groupId': 'OG020'}, {'value': '20', 'groupId': 'OG021'}, {'value': '38', 'groupId': 'OG022'}, {'value': '20', 'groupId': 'OG023'}, {'value': '58', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '44.4', 'groupId': 'OG000'}, {'value': '8.00', 'spread': '22', 'groupId': 'OG001'}, {'value': '21.9', 'spread': '34.5', 'groupId': 'OG002'}, {'value': '56.7', 'spread': '32.2', 'groupId': 'OG003'}, {'value': '77.4', 'spread': '29.9', 'groupId': 'OG004'}, {'value': '224', 'spread': '27', 'groupId': 'OG005'}, {'value': '248', 'spread': '27.8', 'groupId': 'OG006'}, {'value': '3.16', 'spread': '44.9', 'groupId': 'OG007'}, {'value': '8.62', 'spread': '17.6', 'groupId': 'OG008'}, {'value': '23.7', 'spread': '21.9', 'groupId': 'OG009'}, {'value': '74.9', 'spread': '28.8', 'groupId': 'OG010'}, {'value': '216', 'spread': '19.9', 'groupId': 'OG011'}, {'value': '271', 'spread': '20.7', 'groupId': 'OG012'}, {'value': '1.80', 'spread': '17.9', 'groupId': 'OG013'}, {'value': '6.88', 'spread': '25.2', 'groupId': 'OG014'}, {'value': '20.2', 'spread': '48.9', 'groupId': 'OG015'}, {'value': '56.7', 'spread': '32.2', 'groupId': 'OG016'}, {'value': '80.0', 'spread': '37.5', 'groupId': 'OG017'}, {'value': '252', 'spread': '46.6', 'groupId': 'OG018'}, {'value': '223', 'spread': '26.5', 'groupId': 'OG019'}, {'value': '248', 'spread': '20.5', 'groupId': 'OG020'}, {'value': '219', 'spread': '23.6', 'groupId': 'OG021'}, {'value': '281', 'spread': '35.7', 'groupId': 'OG022'}, {'value': '244', 'spread': '33.9', 'groupId': 'OG023'}, {'value': '234', 'spread': '24.5', 'groupId': 'OG024'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '163', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '138', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '163', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '34', 'groupId': 'OG019'}, {'value': '35', 'groupId': 'OG020'}, {'value': '18', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '20', 'groupId': 'OG023'}, {'value': '50', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '2.44', 'spread': '46.5', 'groupId': 'OG000'}, {'value': '8.62', 'spread': '29.2', 'groupId': 'OG001'}, {'value': '19.3', 'spread': '47.1', 'groupId': 'OG002'}, {'value': '56.8', 'spread': '34.9', 'groupId': 'OG003'}, {'value': '76.7', 'spread': '21.1', 'groupId': 'OG004'}, {'value': '247', 'spread': '32', 'groupId': 'OG005'}, {'value': '247', 'spread': '36.6', 'groupId': 'OG006'}, {'value': '2.67', 'spread': '97.4', 'groupId': 'OG007'}, {'value': '9.65', 'spread': '19.6', 'groupId': 'OG008'}, {'value': '20.8', 'spread': '21.8', 'groupId': 'OG009'}, {'value': '70.6', 'spread': '23.3', 'groupId': 'OG010'}, {'value': '222', 'spread': '15.8', 'groupId': 'OG011'}, {'value': '301', 'spread': '18', 'groupId': 'OG012'}, {'value': '2.30', 'spread': '21.4', 'groupId': 'OG013'}, {'value': '6.88', 'spread': '35.3', 'groupId': 'OG014'}, {'value': '17.9', 'spread': '74', 'groupId': 'OG015'}, {'value': '56.8', 'spread': '34.9', 'groupId': 'OG016'}, {'value': '83.3', 'spread': '19.2', 'groupId': 'OG017'}, {'value': '238', 'spread': '58.9', 'groupId': 'OG018'}, {'value': '250', 'spread': '31.5', 'groupId': 'OG019'}, {'value': '228', 'spread': '53.8', 'groupId': 'OG020'}, {'value': '245', 'spread': '25.5', 'groupId': 'OG021'}, {'value': '266', 'spread': '35.4', 'groupId': 'OG023'}, {'value': '240', 'spread': '28.6', 'groupId': 'OG024'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '15', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '3', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '19.2', 'spread': '138.4', 'groupId': 'OG003'}, {'value': '150', 'spread': '54', 'groupId': 'OG005'}, {'value': '272', 'spread': '45.6', 'groupId': 'OG006'}, {'value': '272', 'spread': '45.6', 'groupId': 'OG012'}, {'value': '19.2', 'spread': '138.4', 'groupId': 'OG016'}, {'value': '150', 'spread': '54', 'groupId': 'OG019'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '79', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '85', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}, {'value': '19', 'groupId': 'OG019'}, {'value': '19', 'groupId': 'OG020'}, {'value': '12', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '15', 'groupId': 'OG023'}, {'value': '24', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '3.02', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '6.11', 'spread': '39.4', 'groupId': 'OG001'}, {'value': '27.0', 'spread': '30.6', 'groupId': 'OG002'}, {'value': '58.6', 'spread': '34.6', 'groupId': 'OG003'}, {'value': '54.0', 'spread': '9.3', 'groupId': 'OG004'}, {'value': '253', 'spread': '35', 'groupId': 'OG005'}, {'value': '265', 'spread': '32.2', 'groupId': 'OG006'}, {'value': '24.5', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG009'}, {'value': '55.3', 'spread': '11.8', 'groupId': 'OG010'}, {'value': '332', 'spread': '19.4', 'groupId': 'OG012'}, {'value': '3.02', 'spread': '6.3', 'groupId': 'OG013'}, {'value': '6.11', 'spread': '39.4', 'groupId': 'OG014'}, {'value': '28.3', 'spread': '42.5', 'groupId': 'OG015'}, {'value': '58.6', 'spread': '34.6', 'groupId': 'OG016'}, {'value': '51.4', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG017'}, {'value': '145', 'spread': '37.5', 'groupId': 'OG018'}, {'value': '269', 'spread': '29.4', 'groupId': 'OG019'}, {'value': '252', 'spread': '26.1', 'groupId': 'OG020'}, {'value': '267', 'spread': '35.7', 'groupId': 'OG021'}, {'value': '262', 'spread': '34.5', 'groupId': 'OG023'}, {'value': '254', 'spread': '35.9', 'groupId': 'OG024'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '8', 'groupId': 'OG024'}]}], 'categories': [{'measurements': [{'value': '292', 'spread': '26.6', 'groupId': 'OG006'}, {'value': '292', 'spread': '26.6', 'groupId': 'OG024'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the Cmax of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}, {'type': 'SECONDARY', 'title': 'AUC0-inf of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '197', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '40', 'groupId': 'OG007'}, {'value': '40', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '36', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '54', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Pembrolizumab 200 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with favezelimab (MK-4280A).'}, {'id': 'OG001', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG007', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG010', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'OG011', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG012', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '197', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '40', 'groupId': 'OG007'}, {'value': '40', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '36', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '54', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '586', 'spread': '38.9', 'groupId': 'OG000'}, {'value': '662', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '332', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG002'}, {'value': '612', 'spread': '40.8', 'groupId': 'OG003'}, {'value': '564', 'spread': '40.8', 'groupId': 'OG004'}, {'value': '821', 'spread': '18.2', 'groupId': 'OG005'}, {'value': '543', 'spread': '27.4', 'groupId': 'OG006'}, {'value': '586', 'spread': '39.1', 'groupId': 'OG007'}, {'value': '589', 'spread': '34.4', 'groupId': 'OG008'}, {'value': '626', 'spread': '26.7', 'groupId': 'OG009'}, {'value': '623', 'spread': '44.6', 'groupId': 'OG010'}, {'value': '661', 'spread': '32.9', 'groupId': 'OG011'}, {'value': '619', 'spread': '41.3', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '19', 'groupId': 'OG011'}, {'value': '45', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '843', 'spread': '52.1', 'groupId': 'OG000'}, {'value': '1060', 'spread': '22.4', 'groupId': 'OG001'}, {'value': '613', 'spread': '100.5', 'groupId': 'OG002'}, {'value': '940', 'spread': '46.3', 'groupId': 'OG003'}, {'value': '807', 'spread': '50.6', 'groupId': 'OG004'}, {'value': '727', 'spread': '67.2', 'groupId': 'OG005'}, {'value': '847', 'spread': '23.2', 'groupId': 'OG006'}, {'value': '877', 'spread': '53.7', 'groupId': 'OG007'}, {'value': '812', 'spread': '41.4', 'groupId': 'OG008'}, {'value': '1150', 'spread': '59.8', 'groupId': 'OG009'}, {'value': '1100', 'spread': '48.8', 'groupId': 'OG011'}, {'value': '861', 'spread': '75.4', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '846', 'spread': '98', 'groupId': 'OG000'}, {'value': '878', 'spread': '72.1', 'groupId': 'OG004'}, {'value': '1990', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '17', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '903', 'spread': '49.2', 'groupId': 'OG000'}, {'value': '1190', 'spread': '17', 'groupId': 'OG001'}, {'value': '503', 'spread': '101.3', 'groupId': 'OG002'}, {'value': '3650', 'spread': '181.2', 'groupId': 'OG003'}, {'value': '894', 'spread': '47.9', 'groupId': 'OG004'}, {'value': '962', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG005'}, {'value': '528', 'spread': '43.0', 'groupId': 'OG006'}, {'value': '997', 'spread': '56.6', 'groupId': 'OG007'}, {'value': '848', 'spread': '37.8', 'groupId': 'OG008'}, {'value': '1000', 'spread': '21.6', 'groupId': 'OG009'}, {'value': '929', 'spread': '35.7', 'groupId': 'OG011'}, {'value': '1040', 'spread': '73', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '1980', 'spread': '54.8', 'groupId': 'OG000'}, {'value': '1970', 'spread': '55', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.', 'unitOfMeasure': 'Day*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}, {'type': 'SECONDARY', 'title': 'AUC0-21 Days of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '197', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '40', 'groupId': 'OG007'}, {'value': '40', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '38', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '54', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Pembrolizumab 200 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with favezelimab (MK-4280A).'}, {'id': 'OG001', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG007', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG010', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'OG011', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG012', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '197', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '40', 'groupId': 'OG007'}, {'value': '40', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '38', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '54', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '427', 'spread': '31.5', 'groupId': 'OG000'}, {'value': '418', 'spread': '13', 'groupId': 'OG001'}, {'value': '485', 'spread': '49', 'groupId': 'OG002'}, {'value': '382', 'spread': '36.7', 'groupId': 'OG003'}, {'value': '412', 'spread': '31.1', 'groupId': 'OG004'}, {'value': '556', 'spread': '15.2', 'groupId': 'OG005'}, {'value': '410', 'spread': '30.0', 'groupId': 'OG006'}, {'value': '422', 'spread': '28.5', 'groupId': 'OG007'}, {'value': '427', 'spread': '25.2', 'groupId': 'OG008'}, {'value': '431', 'spread': '24', 'groupId': 'OG009'}, {'value': '489', 'spread': '39.3', 'groupId': 'OG010'}, {'value': '447', 'spread': '32.8', 'groupId': 'OG011'}, {'value': '427', 'spread': '34.2', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '45', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '561', 'spread': '38', 'groupId': 'OG000'}, {'value': '615', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '504', 'spread': '88.8', 'groupId': 'OG002'}, {'value': '597', 'spread': '38.3', 'groupId': 'OG003'}, {'value': '545', 'spread': '36.6', 'groupId': 'OG004'}, {'value': '662', 'spread': '57.6', 'groupId': 'OG005'}, {'value': '487', 'spread': '27.9', 'groupId': 'OG006'}, {'value': '588', 'spread': '35.4', 'groupId': 'OG007'}, {'value': '553', 'spread': '25.1', 'groupId': 'OG008'}, {'value': '618', 'spread': '22.9', 'groupId': 'OG009'}, {'value': '621', 'spread': '32.4', 'groupId': 'OG011'}, {'value': '547', 'spread': '56.9', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '543', 'spread': '38.7', 'groupId': 'OG000'}, {'value': '537', 'spread': '40.1', 'groupId': 'OG004'}, {'value': '577', 'spread': '43.9', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '17', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '692', 'spread': '39.3', 'groupId': 'OG000'}, {'value': '805', 'spread': '5', 'groupId': 'OG001'}, {'value': '403', 'spread': '74.6', 'groupId': 'OG002'}, {'value': '1050', 'spread': '79.9', 'groupId': 'OG003'}, {'value': '670', 'spread': '36.4', 'groupId': 'OG004'}, {'value': '701', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG005'}, {'value': '416', 'spread': '15.7', 'groupId': 'OG006'}, {'value': '754', 'spread': '45.4', 'groupId': 'OG007'}, {'value': '664', 'spread': '31.9', 'groupId': 'OG008'}, {'value': '769', 'spread': '21.3', 'groupId': 'OG009'}, {'value': '727', 'spread': '36.7', 'groupId': 'OG011'}, {'value': '705', 'spread': '45.7', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '1040', 'spread': '37.5', 'groupId': 'OG000'}, {'value': '1040', 'spread': '37.5', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.', 'unitOfMeasure': 'Day*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}, {'type': 'SECONDARY', 'title': 'Cmax of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '204', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '40', 'groupId': 'OG007'}, {'value': '41', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '38', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '57', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Pembrolizumab 200 mg', 'description': 'This arm is a protocol-specified pooled arm of all participants who received pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with favezelimab (MK-4280A).'}, {'id': 'OG001', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG007', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG010', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'OG011', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG012', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '204', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '40', 'groupId': 'OG007'}, {'value': '41', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '38', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '57', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '59.6', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '58.5', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '60.0', 'spread': '22.1', 'groupId': 'OG002'}, {'value': '52.8', 'spread': '51.5', 'groupId': 'OG003'}, {'value': '58.7', 'spread': '32.3', 'groupId': 'OG004'}, {'value': '74.2', 'spread': '39.1', 'groupId': 'OG005'}, {'value': '57.4', 'spread': '32.8', 'groupId': 'OG006'}, {'value': '63.9', 'spread': '26.2', 'groupId': 'OG007'}, {'value': '61.3', 'spread': '19.2', 'groupId': 'OG008'}, {'value': '55.5', 'spread': '20.5', 'groupId': 'OG009'}, {'value': '65.0', 'spread': '34', 'groupId': 'OG010'}, {'value': '59.6', 'spread': '30.9', 'groupId': 'OG011'}, {'value': '56.6', 'spread': '25.6', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '165', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '34', 'groupId': 'OG007'}, {'value': '35', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '51', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '67.5', 'spread': '34.3', 'groupId': 'OG000'}, {'value': '65.6', 'spread': '21.2', 'groupId': 'OG001'}, {'value': '78.7', 'spread': '48.1', 'groupId': 'OG002'}, {'value': '69.9', 'spread': '37.1', 'groupId': 'OG003'}, {'value': '66.7', 'spread': '29.7', 'groupId': 'OG004'}, {'value': '91.9', 'spread': '14.1', 'groupId': 'OG005'}, {'value': '67.6', 'spread': '9.36', 'groupId': 'OG006'}, {'value': '77.4', 'spread': '33.7', 'groupId': 'OG007'}, {'value': '67.0', 'spread': '22.2', 'groupId': 'OG008'}, {'value': '69.0', 'spread': '22.6', 'groupId': 'OG009'}, {'value': '69.9', 'spread': '32.9', 'groupId': 'OG011'}, {'value': '61.1', 'spread': '55.1', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '36.4', 'spread': '41.9', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '44.2', 'groupId': 'OG004'}, {'value': '35.1', 'spread': '35.3', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '76.1', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '79.6', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '59.3', 'spread': '50.1', 'groupId': 'OG002'}, {'value': '83.7', 'spread': '83', 'groupId': 'OG003'}, {'value': '75.3', 'spread': '26.6', 'groupId': 'OG004'}, {'value': '61.2', 'spread': 'NA', 'comment': 'NA= The Geometric Coefficient of Variation cannot be calculated for a single participant', 'groupId': 'OG005'}, {'value': '56.9', 'spread': '3.48', 'groupId': 'OG006'}, {'value': '90.7', 'spread': '34.5', 'groupId': 'OG007'}, {'value': '75.1', 'spread': '25.1', 'groupId': 'OG008'}, {'value': '76.0', 'spread': '28.7', 'groupId': 'OG009'}, {'value': '73.4', 'spread': '27.3', 'groupId': 'OG011'}, {'value': '74.1', 'spread': '37.4', 'groupId': 'OG012'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '93.8', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '93.8', 'spread': '25.8', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the Cmax of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}, {'type': 'SECONDARY', 'title': 'Predose Serum Concentration of Favezelimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '195', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '41', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '36', 'groupId': 'OG015'}, {'value': '20', 'groupId': 'OG016'}, {'value': '57', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG006', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG007', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG008', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG009', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG010', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG011', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG012', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG013', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'OG014', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'OG015', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'OG016', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'OG017', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '195', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '41', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '36', 'groupId': 'OG015'}, {'value': '20', 'groupId': 'OG016'}, {'value': '57', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG007', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG008', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG009', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG010', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG011', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG012', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG013', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG014', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG015', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG016', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG017', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '167', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '33', 'groupId': 'OG011'}, {'value': '17', 'groupId': 'OG012'}, {'value': '35', 'groupId': 'OG013'}, {'value': '18', 'groupId': 'OG014'}, {'value': '32', 'groupId': 'OG015'}, {'value': '20', 'groupId': 'OG016'}, {'value': '52', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.0361', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.250'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '0.458'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '1.87'}, {'value': '1.52', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '16.0'}, {'value': '1.26', 'groupId': 'OG007', 'lowerLimit': '0.361', 'upperLimit': '2.24'}, {'value': '3.28', 'groupId': 'OG008', 'lowerLimit': '0.577', 'upperLimit': '3.69'}, {'value': '12.9', 'groupId': 'OG009', 'lowerLimit': '11.7', 'upperLimit': '20.7'}, {'value': '23.6', 'groupId': 'OG010', 'lowerLimit': '20.0', 'upperLimit': '27.1'}, {'value': '15.0', 'groupId': 'OG011', 'lowerLimit': '1.62', 'upperLimit': '50.0'}, {'value': '21.8', 'groupId': 'OG012', 'lowerLimit': '0.00', 'upperLimit': '53.5'}, {'value': '13.3', 'groupId': 'OG013', 'lowerLimit': '0.00', 'upperLimit': '45.1'}, {'value': '25.2', 'groupId': 'OG014', 'lowerLimit': '0.685', 'upperLimit': '59.1'}, {'value': '20.1', 'groupId': 'OG015', 'lowerLimit': '0.00', 'upperLimit': '62.7'}, {'value': '27.0', 'groupId': 'OG016', 'lowerLimit': '3.47', 'upperLimit': '149'}, {'value': '12.4', 'groupId': 'OG017', 'lowerLimit': '0.00', 'upperLimit': '58.1'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '132', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '26', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}, {'value': '25', 'groupId': 'OG013'}, {'value': '17', 'groupId': 'OG014'}, {'value': '28', 'groupId': 'OG015'}, {'value': '20', 'groupId': 'OG016'}, {'value': '38', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.250'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '2.06'}, {'value': '1.95', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '29.9'}, {'value': '0.225', 'groupId': 'OG007', 'lowerLimit': '0.00', 'upperLimit': '0.450'}, {'value': '4.48', 'groupId': 'OG008', 'lowerLimit': '4.48', 'upperLimit': '4.48'}, {'value': '28.2', 'groupId': 'OG009', 'lowerLimit': '28.2', 'upperLimit': '28.2'}, {'value': '34.7', 'groupId': 'OG010', 'lowerLimit': '32.3', 'upperLimit': '36.8'}, {'value': '23.7', 'groupId': 'OG011', 'lowerLimit': '2.07', 'upperLimit': '68.5'}, {'value': '37.1', 'groupId': 'OG012', 'lowerLimit': '3.31', 'upperLimit': '389'}, {'value': '14.8', 'groupId': 'OG013', 'lowerLimit': '0.00', 'upperLimit': '46.3'}, {'value': '39.5', 'groupId': 'OG014', 'lowerLimit': '3.81', 'upperLimit': '81.3'}, {'value': '35.8', 'groupId': 'OG015', 'lowerLimit': '0.402', 'upperLimit': '99.3'}, {'value': '43.3', 'groupId': 'OG016', 'lowerLimit': '6.34', 'upperLimit': '119'}, {'value': '19.1', 'groupId': 'OG017', 'lowerLimit': '2.10', 'upperLimit': '67.6'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '91', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '19', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '19', 'groupId': 'OG013'}, {'value': '13', 'groupId': 'OG014'}, {'value': '24', 'groupId': 'OG015'}, {'value': '15', 'groupId': 'OG016'}, {'value': '23', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '1.09', 'groupId': 'OG005', 'lowerLimit': '0.0559', 'upperLimit': '2.12'}, {'value': '2.26', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '19.3'}, {'value': '0.429', 'groupId': 'OG007', 'lowerLimit': '0.00', 'upperLimit': '0.858'}, {'value': '4.54', 'groupId': 'OG008', 'lowerLimit': '4.54', 'upperLimit': '4.54'}, {'value': '31.0', 'groupId': 'OG010', 'lowerLimit': '27.4', 'upperLimit': '34.5'}, {'value': '25.0', 'groupId': 'OG011', 'lowerLimit': '2.51', 'upperLimit': '76.1'}, {'value': '42.0', 'groupId': 'OG012', 'lowerLimit': '4.43', 'upperLimit': '78.4'}, {'value': '20.5', 'groupId': 'OG013', 'lowerLimit': '0.0659', 'upperLimit': '60.9'}, {'value': '45.6', 'groupId': 'OG014', 'lowerLimit': '6.20', 'upperLimit': '85.1'}, {'value': '38.4', 'groupId': 'OG015', 'lowerLimit': '0.00', 'upperLimit': '164'}, {'value': '51.2', 'groupId': 'OG016', 'lowerLimit': '7.08', 'upperLimit': '128'}, {'value': '16.8', 'groupId': 'OG017', 'lowerLimit': '1.06', 'upperLimit': '68.5'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '54', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '19', 'groupId': 'OG015'}, {'value': '15', 'groupId': 'OG016'}, {'value': '20', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '15.1', 'groupId': 'OG004', 'lowerLimit': '15.1', 'upperLimit': '15.1'}, {'value': '1.58', 'groupId': 'OG005', 'lowerLimit': '0.0561', 'upperLimit': '3.10'}, {'value': '3.63', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '19.2'}, {'value': '50.6', 'groupId': 'OG007', 'lowerLimit': '43.8', 'upperLimit': '57.4'}, {'value': '26.9', 'groupId': 'OG011', 'lowerLimit': '6.53', 'upperLimit': '113'}, {'value': '35.1', 'groupId': 'OG012', 'lowerLimit': '29.6', 'upperLimit': '42.2'}, {'value': '18.6', 'groupId': 'OG013', 'lowerLimit': '0.729', 'upperLimit': '68.4'}, {'value': '40.3', 'groupId': 'OG014', 'lowerLimit': '9.21', 'upperLimit': '119'}, {'value': '38.1', 'groupId': 'OG015', 'lowerLimit': '1.14', 'upperLimit': '119'}, {'value': '59.6', 'groupId': 'OG016', 'lowerLimit': '8.96', 'upperLimit': '162'}, {'value': '27.3', 'groupId': 'OG017', 'lowerLimit': '0.464', 'upperLimit': '246'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}, {'value': '13', 'groupId': 'OG015'}, {'value': '8', 'groupId': 'OG016'}, {'value': '15', 'groupId': 'OG017'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '1.09', 'groupId': 'OG005', 'lowerLimit': '0.122', 'upperLimit': '2.05'}, {'value': '4.18', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '13.7'}, {'value': '0.00', 'groupId': 'OG007', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '18.4', 'groupId': 'OG011', 'lowerLimit': '9.48', 'upperLimit': '113'}, {'value': '30.8', 'groupId': 'OG012', 'lowerLimit': '19.1', 'upperLimit': '42.4'}, {'value': '20.7', 'groupId': 'OG013', 'lowerLimit': '5.62', 'upperLimit': '35.9'}, {'value': '51.1', 'groupId': 'OG014', 'lowerLimit': '11.2', 'upperLimit': '109'}, {'value': '49.2', 'groupId': 'OG015', 'lowerLimit': '1.48', 'upperLimit': '161'}, {'value': '64.3', 'groupId': 'OG016', 'lowerLimit': '18.7', 'upperLimit': '203'}, {'value': '23.9', 'groupId': 'OG017', 'lowerLimit': '0.289', 'upperLimit': '84.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose on Day 1 of cycles 1-4, 6, and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the predose serum concentration of favezelimab, which is presented.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}, {'type': 'SECONDARY', 'title': 'AUC0-inf of Lenvatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA= AUC0-inf could not be calculated due to sparse data collection across participants', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA= AUC0-inf could not be calculated due to sparse data collection across participants', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of lenvatinib.', 'unitOfMeasure': 'Day*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of lenvatinib and complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}, {'type': 'SECONDARY', 'title': 'AUC0-21 Days of Lenvatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA= AUC0-21 Days could not be calculated due to sparse data collection across participants', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA= AUC0-21 Days could not be calculated due to sparse data collection across participants', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of lenvatinib.', 'unitOfMeasure': 'Day*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of lenvatinib and complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}, {'type': 'SECONDARY', 'title': 'Cmax of Lenvatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA= Cmax Days could not be calculated due to sparse data collection across participants', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA= Cmax Days could not be calculated due to sparse data collection across participants', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the Cmax of lenvatinib.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ≥1 dose of lenvatinib and complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'FG001', 'title': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'FG002', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'FG003', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'FG004', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'FG005', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'FG006', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'FG007', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'FG008', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'FG009', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'FG010', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.'}, {'id': 'FG011', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'FG012', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'FG013', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'FG014', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'FG015', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'FG016', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'FG017', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '21'}, {'groupId': 'FG011', 'numSubjects': '206'}, {'groupId': 'FG012', 'numSubjects': '40'}, {'groupId': 'FG013', 'numSubjects': '41'}, {'groupId': 'FG014', 'numSubjects': '59'}, {'groupId': 'FG015', 'numSubjects': '20'}, {'groupId': 'FG016', 'numSubjects': '21'}, {'groupId': 'FG017', 'numSubjects': '40'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '20'}, {'groupId': 'FG011', 'numSubjects': '205'}, {'groupId': 'FG012', 'numSubjects': '40'}, {'groupId': 'FG013', 'numSubjects': '41'}, {'groupId': 'FG014', 'numSubjects': '58'}, {'groupId': 'FG015', 'numSubjects': '20'}, {'groupId': 'FG016', 'numSubjects': '20'}, {'groupId': 'FG017', 'numSubjects': '40'}]}, {'type': 'Switched Over to Favezelimab + Pembrolizumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '9'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Received Second Course of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '21'}, {'groupId': 'FG011', 'numSubjects': '206'}, {'groupId': 'FG012', 'numSubjects': '40'}, {'groupId': 'FG013', 'numSubjects': '41'}, {'groupId': 'FG014', 'numSubjects': '59'}, {'groupId': 'FG015', 'numSubjects': '20'}, {'groupId': 'FG016', 'numSubjects': '21'}, {'groupId': 'FG017', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '20'}, {'groupId': 'FG011', 'numSubjects': '166'}, {'groupId': 'FG012', 'numSubjects': '34'}, {'groupId': 'FG013', 'numSubjects': '30'}, {'groupId': 'FG014', 'numSubjects': '45'}, {'groupId': 'FG015', 'numSubjects': '16'}, {'groupId': 'FG016', 'numSubjects': '20'}, {'groupId': 'FG017', 'numSubjects': '28'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '4'}, {'groupId': 'FG015', 'numSubjects': '4'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '27'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '8'}, {'groupId': 'FG014', 'numSubjects': '7'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One participant received 2 randomization numbers due to an erroneous initial randomization, but is only counted once in Participant Flow due to the rapid correction and drug administration only happening after the correction.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '21', 'groupId': 'BG010'}, {'value': '206', 'groupId': 'BG011'}, {'value': '40', 'groupId': 'BG012'}, {'value': '41', 'groupId': 'BG013'}, {'value': '59', 'groupId': 'BG014'}, {'value': '20', 'groupId': 'BG015'}, {'value': '21', 'groupId': 'BG016'}, {'value': '40', 'groupId': 'BG017'}, {'value': '481', 'groupId': 'BG018'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG001', 'title': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG002', 'title': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG003', 'title': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG004', 'title': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG005', 'title': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'BG006', 'title': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'BG007', 'title': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'BG008', 'title': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'BG009', 'title': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'BG010', 'title': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG011', 'title': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'BG012', 'title': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'BG013', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.'}, {'id': 'BG014', 'title': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG015', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).'}, {'id': 'BG016', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).'}, {'id': 'BG017', 'title': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.'}, {'id': 'BG018', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '15.5', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '15.3', 'groupId': 'BG002'}, {'value': '48.7', 'spread': '6.1', 'groupId': 'BG003'}, {'value': '52.0', 'spread': '14.7', 'groupId': 'BG004'}, {'value': '54.0', 'spread': '12.2', 'groupId': 'BG005'}, {'value': '52.3', 'spread': '17.1', 'groupId': 'BG006'}, {'value': '64.7', 'spread': '7.5', 'groupId': 'BG007'}, {'value': '55.3', 'spread': '12.4', 'groupId': 'BG008'}, {'value': '68.7', 'spread': '9.6', 'groupId': 'BG009'}, {'value': '60.3', 'spread': '10.6', 'groupId': 'BG010'}, {'value': '58.1', 'spread': '11.2', 'groupId': 'BG011'}, {'value': '58.5', 'spread': '12.0', 'groupId': 'BG012'}, {'value': '57.9', 'spread': '10.9', 'groupId': 'BG013'}, {'value': '56.3', 'spread': '9.7', 'groupId': 'BG014'}, {'value': '58.3', 'spread': '12.1', 'groupId': 'BG015'}, {'value': '59.5', 'spread': '9.9', 'groupId': 'BG016'}, {'value': '61.1', 'spread': '11.0', 'groupId': 'BG017'}, {'value': '58.3', 'spread': '11.05', 'groupId': 'BG018'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '73', 'groupId': 'BG011'}, {'value': '15', 'groupId': 'BG012'}, {'value': '17', 'groupId': 'BG013'}, {'value': '11', 'groupId': 'BG014'}, {'value': '5', 'groupId': 'BG015'}, {'value': '9', 'groupId': 'BG016'}, {'value': '21', 'groupId': 'BG017'}, {'value': '180', 'groupId': 'BG018'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}, {'value': '133', 'groupId': 'BG011'}, {'value': '25', 'groupId': 'BG012'}, {'value': '24', 'groupId': 'BG013'}, {'value': '48', 'groupId': 'BG014'}, {'value': '15', 'groupId': 'BG015'}, {'value': '12', 'groupId': 'BG016'}, {'value': '19', 'groupId': 'BG017'}, {'value': '301', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '25', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '7', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '58', 'groupId': 'BG018'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '19', 'groupId': 'BG010'}, {'value': '174', 'groupId': 'BG011'}, {'value': '33', 'groupId': 'BG012'}, {'value': '32', 'groupId': 'BG013'}, {'value': '52', 'groupId': 'BG014'}, {'value': '19', 'groupId': 'BG015'}, {'value': '12', 'groupId': 'BG016'}, {'value': '39', 'groupId': 'BG017'}, {'value': '406', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '17', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '3', 'groupId': 'BG018'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '36', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '9', 'groupId': 'BG013'}, {'value': '20', 'groupId': 'BG014'}, {'value': '7', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '12', 'groupId': 'BG017'}, {'value': '98', 'groupId': 'BG018'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '1', 'groupId': 'BG018'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '15', 'groupId': 'BG018'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '19', 'groupId': 'BG010'}, {'value': '164', 'groupId': 'BG011'}, {'value': '29', 'groupId': 'BG012'}, {'value': '31', 'groupId': 'BG013'}, {'value': '30', 'groupId': 'BG014'}, {'value': '12', 'groupId': 'BG015'}, {'value': '17', 'groupId': 'BG016'}, {'value': '25', 'groupId': 'BG017'}, {'value': '356', 'groupId': 'BG018'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '2', 'groupId': 'BG017'}, {'value': '3', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '5', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-01', 'size': 5206119, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-04T13:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were allocated to arms in a non-random fashion, except in the case of those with gastric cancer enrolled in Part B, who were randomized 1:1 between Arm 2A and Arm 2B (favezelimab 200 mg and 800 mg, respectively). Part B initiated after determination of a favezelimab recommended phase 2 dose (RP2D) from Part A.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 481}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2016-03-22', 'resultsFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-28', 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)', 'timeFrame': 'Up to 21 days (Cycle 1)', 'description': 'DLTs were assessed during the first cycle (21 days) \\& were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with bleeding; Gr 3 nonhematologic toxicity lasting ≥3 days despite optimal supportive care (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for \\>1 week); Gr 3 or 4 febrile neutropenia; any drug-related AE that caused the participant to discontinue treatment during Cycle 1; Grade 5 toxicity; Any treatment-related toxicity that causes ≥2-week delay in initiation of Cycle 2.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to approximately 31.3 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 28.3 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) for Part B Participants', 'timeFrame': 'Up to approximately 92 months', 'description': 'ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced a CR or PR is presented.'}, {'measure': 'Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.'}, {'measure': 'Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.'}, {'measure': 'Maximum Serum Concentration (Cmax) of Favezelimab', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the Cmax of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.'}, {'measure': 'AUC0-inf of Pembrolizumab', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.'}, {'measure': 'AUC0-21 Days of Pembrolizumab', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.'}, {'measure': 'Cmax of Pembrolizumab', 'timeFrame': 'Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the Cmax of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.'}, {'measure': 'Predose Serum Concentration of Favezelimab', 'timeFrame': 'Predose on Day 1 of cycles 1-4, 6, and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the predose serum concentration of favezelimab, which is presented.'}, {'measure': 'AUC0-inf of Lenvatinib', 'timeFrame': 'Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of lenvatinib.'}, {'measure': 'AUC0-21 Days of Lenvatinib', 'timeFrame': 'Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of lenvatinib.'}, {'measure': 'Cmax of Lenvatinib', 'timeFrame': 'Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1', 'description': 'Blood for serum samples was collected at pre-specified time points to determine the Cmax of lenvatinib.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1)', 'Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)', 'Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)', 'Lymphocyte-activation gene 3 (LAG3, LAG-3, CD223)'], 'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) - Full Text View - ClinicalTrials.gov'}, {'pmid': '36493599', 'type': 'RESULT', 'citation': 'Garralda E, Sukari A, Lakhani NJ, Patnaik A, Lou Y, Im SA, Golan T, Geva R, Wermke M, de Miguel M, Palcza J, Jha S, Chaney M, Abraham AK, Healy J, Falchook GS. A first-in-human study of the anti-LAG-3 antibody favezelimab plus pembrolizumab in previously treated, advanced microsatellite stable colorectal cancer. ESMO Open. 2022 Dec;7(6):100639. doi: 10.1016/j.esmoop.2022.100639. Epub 2022 Dec 6.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'This is a safety and pharmacokinetics study of favezelimab as monotherapy and in combination with pembrolizumab AND favezelimab/pembrolizumab as monotherapy in adults with metastatic solid tumors for which there is no available therapy which may convey clinical benefit. Part A of this study is a dose escalation design in which participants receive favezelimab as monotherapy or favezelimab in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RP2D), as determined by dose-limiting toxicity, for favezelimab in combination with pembrolizumab or pembrolizumab and lenvatinib in participants with advanced solid tumors. Part B will also assess the efficacy of favezelimab as monotherapy; favezelimab in combination with pembrolizumab with and without chemotherapy; favezelimab in combination with pembrolizumab and lenvatinib; and favezelimab/pembrolizumab as monotherapy in expansion cohorts. Participants who have completed the initial course of treatment and have investigator-determined progressive disease may be eligible for a second course of an additional 17 cycles of study treatment.', 'detailedDescription': 'All participants who completed the first course were eligible for second course treatment after Sponsor consultation if there was investigator-determined progressive disease after initial treatment had been been completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part A and Part B: Has histologically or cytologically-confirmed metastatic solid tumor.\n* Has measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 1.1 criteria.\n* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n* Demonstrates adequate organ function.\n* If female, is not pregnant or breastfeeding, and if of child-bearing potential, is willing to use an adequate method of contraception for the course of the study and for at least 180 days after the last dose of chemotherapy, 120 days after the last dose of pembrolizumab or favezelimab, or 30 days after the last dose of lenvatinib, whichever occurs last.\n* If male with a female partner(s) of child-bearing potential, both must agree to use an adequate method of contraception starting with the first dose of study drug through 95 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Has had chemotherapy, radiation or biological cancer therapy within 4 weeks prior to the first dose of study drug, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 or 1 from the AEs due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related \\[ir\\]AEs).\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.\n* Has received previous treatment with another agent targeting the lymphocyte-activation gene 3 (LAG-3) receptor.\n* Has received previous treatment with an immunomodulatory therapy (e.g., anti-programmed cell death-1/anti-programmed cell death-ligand 1 \\[anti-PD-1/anti-PD-L1\\] or cytotoxic T-lymphocyte-associated protein 4 \\[CTLA 4\\] agent) and was discontinued from that therapy due to a Grade 3 or higher irAE.\n* Is expected to require any other form of antineoplastic therapy while on study.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication.\n* Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Time frame exceptions include successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer, or other in situ cancers.\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Has had a severe hypersensitivity reaction to treatment with another monoclonal antibody.\n* Has an active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.\n* Has an active infection requiring therapy.\n* Has history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has had a prior stem cell or bone marrow transplant.\n* Has a known history of or screens positive for Human Immunodeficiency Virus (HIV), active chronic or acute Hepatitis B or Hepatitis C.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n* Is a regular user as determined by investigator judgement (including "recreational use") of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol), at the time of signing informed consent.\n* Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.\n* Has clinically significant heart disease that affects normal activities.\n* Has received a live-virus vaccine within 30 days of planned start of study drug. Seasonal flu vaccines that do not contain live virus are permitted.'}, 'identificationModule': {'nctId': 'NCT02720068', 'briefTitle': 'Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 1 Trial of MK-4280 as Monotherapy and in Combination With Pembrolizumab With or Without Chemotherapy or Lenvatinib (E7080/MK-7902) in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '4280-001'}, 'secondaryIdInfos': [{'id': 'MK-4280-001', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': '183971', 'type': 'OTHER', 'domain': 'JAPIC-CTI'}, {'id': '2017-001464-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 7 mg Monotherapy', 'description': 'Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 21 mg Monotherapy', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 70 mg Monotherapy', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 210 mg Monotherapy', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 700 mg Monotherapy', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)', 'description': 'Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'description': 'Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'description': 'Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV, and fluorouracil \\[5-FU\\] 2400 mg/m\\^2 IV over 46 to 48 hours, every 2 weeks \\[Q2W\\]).', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab', 'Drug: Oxaliplatin', 'Drug: Leucovorin (Calcium Folinate)', 'Drug: Fluorouracil [5-FU]']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\\^2 IV, leucovorin \\[calcium folinate\\] 400 mg/m\\^2 IV and 5-FU 2400 mg/m\\^2 IV over 46 to 48 hours, Q2W).', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab', 'Drug: Irinotecan', 'Drug: Leucovorin (Calcium Folinate)', 'Drug: Fluorouracil [5-FU]']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: MK-4280A (Arm 5)', 'description': 'Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.', 'interventionNames': ['Biological: Favezelimab/Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'description': 'Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.', 'interventionNames': ['Biological: Favezelimab', 'Biological: Pembrolizumab', 'Drug: Lenvatinib']}], 'interventions': [{'name': 'Favezelimab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-4280'], 'description': 'IV infusion', 'armGroupLabels': ['Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'Part A: Favezelimab 21 mg Monotherapy', 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'Part A: Favezelimab 210 mg Monotherapy', 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'Part A: Favezelimab 7 mg Monotherapy', 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'Part A: Favezelimab 70 mg Monotherapy', 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'Part A: Favezelimab 700 mg Monotherapy', 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)', 'Part B: Favezelimab 800 mg Monotherapy (Arm 1)']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'KEYTRUDA®'], 'description': 'IV infusion', 'armGroupLabels': ['Part A: Favezelimab 21 mg + Pembrolizumab 200 mg', 'Part A: Favezelimab 210 mg + Pembrolizumab 200 mg', 'Part A: Favezelimab 7 mg + Pembrolizumab 200 mg', 'Part A: Favezelimab 70 mg + Pembrolizumab 200 mg', 'Part A: Favezelimab 700 mg + Pembrolizumab 200 mg', 'Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)', 'Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['ELOXATIN®'], 'description': 'IV infusion', 'armGroupLabels': ['Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['CAMPTOSAR®'], 'description': 'IV infusion', 'armGroupLabels': ['Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)']}, {'name': 'Leucovorin (Calcium Folinate)', 'type': 'DRUG', 'otherNames': ['WELLCOVORIN®'], 'description': 'IV infusion', 'armGroupLabels': ['Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)']}, {'name': 'Fluorouracil [5-FU]', 'type': 'DRUG', 'otherNames': ['ADRUCIL®'], 'description': 'IV infusion', 'armGroupLabels': ['Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)', 'Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)']}, {'name': 'Favezelimab/Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-4280A'], 'description': 'IV infusion', 'armGroupLabels': ['Part B: MK-4280A (Arm 5)']}, {'name': 'Lenvatinib', 'type': 'DRUG', 'otherNames': ['E7080', 'MK-7902', 'LENVIMA®'], 'description': 'Oral', 'armGroupLabels': ['Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}