Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT02972034
Status:
TERMINATED
Last Update Posted:
2024-11-21
First Post:
2016-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632607', 'term': 'MK-8353'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to ~ 27 months', 'description': 'All-cause mortality includes all allocated participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 13, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Arm A: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Arm A: MK-8353 50 + 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg plus 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 4, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 8, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 11, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 5, 'seriousNumAffected': 5}, {'id': 'EG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 11, 'seriousNumAffected': 5}, {'id': 'EG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 10, 'seriousNumAffected': 4}, {'id': 'EG014', 'title': 'Arm C: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 300 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 9, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '11', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG001', 'title': 'Arm A: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG002', 'title': 'Arm A: MK-8353 50 + 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg plus 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG014', 'title': 'Arm C: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 300 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '11', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 27 months', 'description': 'Number of participants who experienced an AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '11', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG001', 'title': 'Arm A: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG002', 'title': 'Arm A: MK-8353 50 + 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg plus 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG014', 'title': 'Arm C: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 300 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Dose-Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '9', 'groupId': 'OG013'}, {'value': '10', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG001', 'title': 'Arm A: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG002', 'title': 'Arm A: MK-8353 50 + 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg plus 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG014', 'title': 'Arm C: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 300 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (Arms A, B & C: Up to 21 days)', 'description': 'DLT was defined as a treatment-related adverse event (AE) including the following: Grade (Gr) 4 nonhematologic toxicity (not laboratory), Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia or Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with clinically significant bleeding, Gr 3 non-hematological AE with the exception of fatigue lasting \\>3 days despite optimal supportive care, any Gr 3 or Gr 4 nonhematologic laboratory value if medical intervention is required to treat the subject, or abnormality leads to hospitalization or abnormality persists for \\>1 week, Gr 3 or Gr 4 febrile neutropenia, prolonged delay (\\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity, any treatment-related toxicity that causes the subject to discontinue treatment during Cycle 1, missing \\>25% of MK-8353 doses as a result of drug-related AE(s) during the first cycle, Gr 5 toxicity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT evaluable population consisted of all participants who completed the first cycle of study treatment or who discontinued from the study due to a drug-related AE.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}, {'value': '11', 'groupId': 'OG013'}, {'value': '11', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG001', 'title': 'Arm A: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG002', 'title': 'Arm A: MK-8353 50 + 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg plus 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG014', 'title': 'Arm C: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 300 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '23.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '41.0'}, {'value': '20.0', 'groupId': 'OG008', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '21.4', 'groupId': 'OG009', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '25.0', 'groupId': 'OG010', 'lowerLimit': '3.2', 'upperLimit': '65.1'}, {'value': '0.0', 'groupId': 'OG011', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '7.7', 'groupId': 'OG012', 'lowerLimit': '0.2', 'upperLimit': '36.0'}, {'value': '0.0', 'groupId': 'OG013', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG014', 'lowerLimit': '0.0', 'upperLimit': '28.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': 'ORR was defined as the percentage of the participants in the analysis population who have 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, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by Investigator was presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all participants who had a baseline scan with measurable disease by investigator assessment and who were administered a dose of the study treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Cancer Antigen 125 (CA-125)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG001', 'title': 'Arm A: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG002', 'title': 'Arm A: MK-8353 50 + 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg plus 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG014', 'title': 'Arm C: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 300 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}], 'classes': [{'title': 'Day 1 Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '15.47', 'groupId': 'OG000', 'lowerLimit': '-15.2', 'upperLimit': '56.7'}, {'value': '17.2', 'groupId': 'OG002', 'lowerLimit': '17.2', 'upperLimit': '17.2'}, {'value': '-13.3', 'groupId': 'OG004', 'lowerLimit': '-13.3', 'upperLimit': '-13.3'}, {'value': '68.3', 'groupId': 'OG005', 'lowerLimit': '68.3', 'upperLimit': '68.3'}, {'value': '83.75', 'groupId': 'OG006', 'lowerLimit': '-9.3', 'upperLimit': '176.8'}, {'value': '39.85', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '137.2'}, {'value': '11.00', 'groupId': 'OG010', 'lowerLimit': '-75.8', 'upperLimit': '97.8'}, {'value': '367.6', 'groupId': 'OG011', 'lowerLimit': '367.6', 'upperLimit': '367.6'}, {'value': '-60.00', 'groupId': 'OG012', 'lowerLimit': '-60.0', 'upperLimit': '-60.0'}, {'value': '36.36', 'groupId': 'OG014', 'lowerLimit': '-11.8', 'upperLimit': '112.5'}]}]}, {'title': 'Day 1 Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '42.69', 'groupId': 'OG000', 'lowerLimit': '-27.3', 'upperLimit': '80.0'}, {'value': '33.0', 'groupId': 'OG002', 'lowerLimit': '33.0', 'upperLimit': '33.0'}, {'value': '-13.3', 'groupId': 'OG004', 'lowerLimit': '-13.3', 'upperLimit': '-13.3'}, {'value': '-31.21', 'groupId': 'OG006', 'lowerLimit': '-46.4', 'upperLimit': '-16.0'}, {'value': '80.55', 'groupId': 'OG007', 'lowerLimit': '11.1', 'upperLimit': '221.8'}, {'value': '262.56', 'groupId': 'OG010', 'lowerLimit': '-87.9', 'upperLimit': '613.0'}, {'value': '300.3', 'groupId': 'OG011', 'lowerLimit': '300.3', 'upperLimit': '300.3'}, {'value': '-78.8', 'groupId': 'OG012', 'lowerLimit': '-78.8', 'upperLimit': '-78.8'}, {'value': '-5.10', 'groupId': 'OG014', 'lowerLimit': '-23.5', 'upperLimit': '13.3'}]}]}, {'title': 'Day 1 Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '103.10', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '109.5'}, {'value': '-13.3', 'groupId': 'OG004', 'lowerLimit': '-13.3', 'upperLimit': '-13.3'}, {'value': '-24.19', 'groupId': 'OG006', 'lowerLimit': '-71.4', 'upperLimit': '23.0'}, {'value': '42.26', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '87.5'}, {'value': '359.1', 'groupId': 'OG011', 'lowerLimit': '359.1', 'upperLimit': '359.1'}, {'value': '-78.8', 'groupId': 'OG012', 'lowerLimit': '-78.8', 'upperLimit': '-78.8'}, {'value': '-10.05', 'groupId': 'OG014', 'lowerLimit': '-11.8', 'upperLimit': '-8.3'}]}]}, {'title': 'Day 1 Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '153.25', 'groupId': 'OG000', 'lowerLimit': '70.0', 'upperLimit': '236.5'}, {'value': '-13.3', 'groupId': 'OG004', 'lowerLimit': '-13.3', 'upperLimit': '-13.3'}, {'value': '-76.8', 'groupId': 'OG006', 'lowerLimit': '-76.8', 'upperLimit': '-76.8'}, {'value': '22.2', 'groupId': 'OG007', 'lowerLimit': '22.2', 'upperLimit': '22.2'}, {'value': '-88.89', 'groupId': 'OG010', 'lowerLimit': '-88.89', 'upperLimit': '-88.89'}, {'value': '451.9', 'groupId': 'OG011', 'lowerLimit': '451.9', 'upperLimit': '451.9'}, {'value': '-82.4', 'groupId': 'OG012', 'lowerLimit': '-82.4', 'upperLimit': '-82.4'}]}]}, {'title': 'Day 1 Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '-6.7', 'groupId': 'OG004', 'lowerLimit': '-6.7', 'upperLimit': '-6.7'}, {'value': '-75.0', 'groupId': 'OG006', 'lowerLimit': '-75.0', 'upperLimit': '-75.0'}, {'value': '-88.89', 'groupId': 'OG010', 'lowerLimit': '-88.89', 'upperLimit': '-88.89'}, {'value': '-87.1', 'groupId': 'OG012', 'lowerLimit': '-87.1', 'upperLimit': '-87.1'}, {'value': '-25.0', 'groupId': 'OG014', 'lowerLimit': '-25.0', 'upperLimit': '-25.0'}]}]}, {'title': 'Day 1 Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', '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': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000', 'lowerLimit': '36.7', 'upperLimit': '36.7'}, {'value': '-89.9', 'groupId': 'OG010', 'lowerLimit': '-89.9', 'upperLimit': '-89.9'}, {'value': '-84.7', 'groupId': 'OG012'}, {'value': '-16.7', 'groupId': 'OG014'}]}]}, {'title': 'Day 1 Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', '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': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.3'}, {'value': '-90.9', 'groupId': 'OG010', 'lowerLimit': '-90.9', 'upperLimit': '-90.9'}, {'value': '-16.7', 'groupId': 'OG014', 'lowerLimit': '-16.7', 'upperLimit': '-16.7'}]}]}, {'title': 'End of treatment/ Safety Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '118.18', 'groupId': 'OG000', 'lowerLimit': '-36.7', 'upperLimit': '273.0'}, {'value': '101.7', 'groupId': 'OG002', 'lowerLimit': '101.7', 'upperLimit': '101.7'}, {'value': '329.3', 'groupId': 'OG005', 'lowerLimit': '329.3', 'upperLimit': '329.3'}, {'value': '2.69', 'groupId': 'OG006', 'lowerLimit': '-76.8', 'upperLimit': '82.2'}, {'value': '256.48', 'groupId': 'OG007', 'lowerLimit': '157.1', 'upperLimit': '355.8'}, {'value': '38.6', 'groupId': 'OG008', 'lowerLimit': '38.6', 'upperLimit': '38.6'}, {'value': '695.94', 'groupId': 'OG009', 'lowerLimit': '164.3', 'upperLimit': '1227.6'}, {'value': '-30.24', 'groupId': 'OG010', 'lowerLimit': '-89.9', 'upperLimit': '29.4'}, {'value': '87.88', 'groupId': 'OG014', 'lowerLimit': '-11.8', 'upperLimit': '376.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1-8 Day 1, and end of treatment/ safety follow-up (30 days after the last dose). Each cycle was 21 days.', 'description': 'CA-125 was the tumour biomarker used to test cancer. Disease progression is indicated by CA-125 tumor marker elevation.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all participants who had a baseline scan with measurable disease by investigator assessment, CA-125 data available for each timepoint and who were administered a dose of the study treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Carcinoembryonic Antigen (CEA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG001', 'title': 'Arm A: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG002', 'title': 'Arm A: MK-8353 50 + 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg plus 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG014', 'title': 'Arm C: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 300 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}], 'classes': [{'title': 'Day 1 Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000', 'lowerLimit': '-64.4', 'upperLimit': '83.0'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '8.3', 'upperLimit': '8.3'}, {'value': '-0.27', 'groupId': 'OG003', 'lowerLimit': '-17.2', 'upperLimit': '16.7'}, {'value': '54.41', 'groupId': 'OG004', 'lowerLimit': '26.9', 'upperLimit': '81.5'}, {'value': '-6.72', 'groupId': 'OG005', 'lowerLimit': '-16.7', 'upperLimit': '3.2'}, {'value': '-80.1', 'groupId': 'OG006', 'lowerLimit': '-80.1', 'upperLimit': '-80.1'}, {'value': '-13.8', 'groupId': 'OG007', 'lowerLimit': '-38.4', 'upperLimit': '4.9'}, {'value': '21.6', 'groupId': 'OG008', 'lowerLimit': '21.6', 'upperLimit': '21.6'}, {'value': '46.01', 'groupId': 'OG009', 'lowerLimit': '4.9', 'upperLimit': '66.8'}, {'value': '18.68', 'groupId': 'OG010', 'lowerLimit': '16.7', 'upperLimit': '20.7'}, {'value': '7.75', 'groupId': 'OG011', 'lowerLimit': '-6.3', 'upperLimit': '22.4'}, {'value': '47.43', 'groupId': 'OG012', 'lowerLimit': '-12.2', 'upperLimit': '204.2'}, {'value': '58.20', 'groupId': 'OG013', 'lowerLimit': '34.6', 'upperLimit': '91.2'}, {'value': '62.24', 'groupId': 'OG014', 'lowerLimit': '-18.8', 'upperLimit': '172.5'}]}]}, {'title': 'Day 1 Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '45.35', 'groupId': 'OG000', 'lowerLimit': '-37.1', 'upperLimit': '162.8'}, {'value': '5.6', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '5.6'}, {'value': '113.63', 'groupId': 'OG004', 'lowerLimit': '66.2', 'upperLimit': '161.3'}, {'value': '-93.9', 'groupId': 'OG006', 'lowerLimit': '-93.9', 'upperLimit': '-93.9'}, {'value': '4.86', 'groupId': 'OG007', 'lowerLimit': '-18.5', 'upperLimit': '33.1'}, {'value': '9.0', 'groupId': 'OG008', 'lowerLimit': '9.0', 'upperLimit': '9.0'}, {'value': '66.7', 'groupId': 'OG010', 'lowerLimit': '66.7', 'upperLimit': '66.7'}, {'value': '35.17', 'groupId': 'OG011', 'lowerLimit': '31.3', 'upperLimit': '39.1'}, {'value': '129.52', 'groupId': 'OG012', 'lowerLimit': '-10.5', 'upperLimit': '525.0'}, {'value': '23.8', 'groupId': 'OG013', 'lowerLimit': '23.8', 'upperLimit': '23.8'}, {'value': '129.98', 'groupId': 'OG014', 'lowerLimit': '-18.8', 'upperLimit': '316.0'}]}]}, {'title': 'Day 1 Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '-1.84', 'groupId': 'OG000', 'lowerLimit': '-26.7', 'upperLimit': '42.9'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '199.86', 'groupId': 'OG004', 'lowerLimit': '90.0', 'upperLimit': '309.7'}, {'value': '-95.1', 'groupId': 'OG006', 'lowerLimit': '-95.1', 'upperLimit': '-95.1'}, {'value': '19.07', 'groupId': 'OG007', 'lowerLimit': '6.7', 'upperLimit': '31.5'}, {'value': '-38.1', 'groupId': 'OG008', 'lowerLimit': '-38.1', 'upperLimit': '-38.1'}, {'value': '17.6', 'groupId': 'OG009', 'lowerLimit': '17.6', 'upperLimit': '17.6'}, {'value': '178.49', 'groupId': 'OG011', 'lowerLimit': '25.0', 'upperLimit': '332.0'}, {'value': '36.58', 'groupId': 'OG012', 'lowerLimit': '-10.5', 'upperLimit': '91.7'}, {'value': '-51.1', 'groupId': 'OG013', 'lowerLimit': '-51.1', 'upperLimit': '-51.1'}, {'value': '315.8', 'groupId': 'OG014', 'lowerLimit': '315.8', 'upperLimit': '315.8'}]}]}, {'title': 'Day 1 Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '-8.08', 'groupId': 'OG000', 'lowerLimit': '-39.5', 'upperLimit': '28.6'}, {'value': '66.67', 'groupId': 'OG003', 'lowerLimit': '66.67', 'upperLimit': '66.67'}, {'value': '197.72', 'groupId': 'OG004', 'lowerLimit': '63.2', 'upperLimit': '332.3'}, {'value': '-96.5', 'groupId': 'OG006', 'lowerLimit': '-96.5', 'upperLimit': '-96.5'}, {'value': '106.6', 'groupId': 'OG007', 'lowerLimit': '106.6', 'upperLimit': '106.6'}, {'value': '-44.2', 'groupId': 'OG008', 'lowerLimit': '-44.2', 'upperLimit': '-44.2'}, {'value': '50.00', 'groupId': 'OG011', 'lowerLimit': '50.00', 'upperLimit': '50.00'}, {'value': '42.31', 'groupId': 'OG012', 'lowerLimit': '-15.8', 'upperLimit': '82.7'}, {'value': '-67.8', 'groupId': 'OG013', 'lowerLimit': '-67.8', 'upperLimit': '-67.8'}]}]}, {'title': 'Day 1 Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '2.88', 'groupId': 'OG000', 'lowerLimit': '-2.88', 'upperLimit': '28.6'}, {'value': '61.1', 'groupId': 'OG003', 'lowerLimit': '61.1', 'upperLimit': '61.1'}, {'value': '445.2', 'groupId': 'OG004', 'lowerLimit': '445.2', 'upperLimit': '445.2'}, {'value': '-96.6', 'groupId': 'OG006', 'lowerLimit': '-96.6', 'upperLimit': '-96.6'}, {'value': '29.4', 'groupId': 'OG009', 'lowerLimit': '29.4', 'upperLimit': '29.4'}, {'value': '24.7', 'groupId': 'OG012', 'lowerLimit': '-21.1', 'upperLimit': '70.0'}, {'value': '-35.8', 'groupId': 'OG013', 'lowerLimit': '-35.8', 'upperLimit': '-35.8'}]}]}, {'title': 'Day 1 Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', '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': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '29.64', 'groupId': 'OG000', 'lowerLimit': '28.6', 'upperLimit': '30.7'}, {'value': '70.0', 'groupId': 'OG012', 'lowerLimit': '70.0', 'upperLimit': '70.0'}]}]}, {'title': 'Day 1 Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', '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': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '27.01', 'groupId': 'OG000', 'lowerLimit': '25.4', 'upperLimit': '28.6'}, {'value': '0.00', 'groupId': 'OG009', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'Day 1 Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', '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': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '28.6', 'upperLimit': '28.6'}, {'value': '23.5', 'groupId': 'OG009', 'lowerLimit': '23.5', 'upperLimit': '23.5'}]}]}, {'title': 'End of treatment/ Safety Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 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cycle for up to 35 cycles.'}, {'id': 'OG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'OG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'OG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV 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'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '16.7'}, {'value': '202.7', 'groupId': 'OG004', 'lowerLimit': '202.7', 'upperLimit': '202.7'}, {'value': '-73.9', 'groupId': 'OG006', 'lowerLimit': '-73.9', 'upperLimit': '-73.9'}, {'value': '25.00', 'groupId': 'OG011', 'lowerLimit': '25.00', 'upperLimit': '25.00'}, {'value': '-10.5', 'groupId': 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Disease progression is indicated by CA19-9 tumor marker elevation', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all participants who had a baseline scan with measurable disease by investigator assessment, CA19-9 data available for each timepoint and who were administered a dose of the study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG001', 'title': 'Arm A: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG002', 'title': 'Arm A: MK-8353 50 + 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg plus 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'FG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'FG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'FG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'FG014', 'title': 'Arm C: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 300 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '14'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '14'}, {'groupId': 'FG013', 'numSubjects': '11'}, {'groupId': 'FG014', 'numSubjects': '11'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '14'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '13'}, {'groupId': 'FG013', 'numSubjects': '11'}, {'groupId': 'FG014', 'numSubjects': '11'}]}, {'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'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '14'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '14'}, {'groupId': 'FG013', 'numSubjects': '11'}, {'groupId': 'FG014', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '11'}, {'groupId': 'FG013', 'numSubjects': '10'}, {'groupId': 'FG014', 'numSubjects': '9'}]}, {'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': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'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': '1'}]}, {'type': 'Physician 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': '1'}, {'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': '0'}]}, {'type': 'Sponsor 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': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Screen Failure', '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': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "This study was planned to have two parts. Part 1 was dose escalation and confirmation, and Part 2 was a cohort expansion. The cohort expansion phase (Part 2) was not initiated due to Sponsor's business decision."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '14', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '14', 'groupId': 'BG012'}, {'value': '11', 'groupId': 'BG013'}, {'value': '11', 'groupId': 'BG014'}, {'value': '111', 'groupId': 'BG015'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG001', 'title': 'Arm A: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG002', 'title': 'Arm A: MK-8353 50 + 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 50 mg plus 100 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG003', 'title': 'Arm A: MK-8353 350 mg + Pembrolizumab', 'description': 'Participants received MK-8353 350 mg orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG004', 'title': 'Arm B: MK-8353 50 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 50 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG005', 'title': 'Arm B: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 100 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG006', 'title': 'Arm B: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 150 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG007', 'title': 'Arm B: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 200 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG008', 'title': 'Arm B: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 300 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG009', 'title': 'Arm B: MK-8353 400 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 400 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG010', 'title': 'Arm B: MK-8353 600 mg + Pembrolizumab', 'description': 'Participants received MK-8353 PO 600 mg once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.'}, {'id': 'BG011', 'title': 'Arm C: MK-8353 100 mg + Pembrolizumab', 'description': 'Participants received MK-8353 100 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'BG012', 'title': 'Arm C: MK-8353 150 mg + Pembrolizumab', 'description': 'Participants received MK-8353 150 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'BG013', 'title': 'Arm C: MK-8353 200 mg + Pembrolizumab', 'description': 'Participants received MK-8353 200 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'BG014', 'title': 'Arm C: MK-8353 300 mg + Pembrolizumab', 'description': 'Participants received MK-8353 300 mg PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.'}, {'id': 'BG015', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '51.0', 'spread': 'NA', 'comment': 'Method of dispersion could not be estimated due to N=1', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '46.0', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '57.5', 'spread': '11.1', 'groupId': 'BG004'}, {'value': '60.0', 'spread': '14.5', 'groupId': 'BG005'}, {'value': '57.5', 'spread': '6.2', 'groupId': 'BG006'}, {'value': '63.1', 'spread': '8.5', 'groupId': 'BG007'}, {'value': '61.1', 'spread': '10.3', 'groupId': 'BG008'}, {'value': '59.5', 'spread': '8.1', 'groupId': 'BG009'}, {'value': '62.1', 'spread': '11.6', 'groupId': 'BG010'}, {'value': '58.0', 'spread': '19.3', 'groupId': 'BG011'}, {'value': '53.0', 'spread': '8.9', 'groupId': 'BG012'}, {'value': '64.1', 'spread': '8.2', 'groupId': 'BG013'}, {'value': '57.6', 'spread': '12.8', 'groupId': 'BG014'}, {'value': '58.3', 'spread': '10.4', 'groupId': 'BG015'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}, {'value': '49', 'groupId': 'BG015'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '9', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '62', 'groupId': 'BG015'}]}]}], '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': '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'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '12', 'groupId': 'BG012'}, {'value': '11', 'groupId': 'BG013'}, {'value': '9', 'groupId': 'BG014'}, {'value': '94', 'groupId': 'BG015'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '17', 'groupId': 'BG015'}]}]}], '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': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}]}, {'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': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '9', 'groupId': 'BG015'}]}, {'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': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}]}, {'title': 'Black or African American', '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': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '12', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}, {'value': '95', 'groupId': 'BG015'}]}, {'title': 'More than one race', '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': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}]}, {'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': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': 'ECOG = 0', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '41', 'groupId': 'BG015'}]}]}, {'title': 'ECOG = 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '5', 'groupId': 'BG014'}, {'value': '69', 'groupId': 'BG015'}]}]}, {'title': 'Missing', 'categories': [{'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': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants in the study were required to have an ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature). The analysis population consisted of all participants who received received at least 1 dose of study intervention.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population consisted of all participants who received received at least 1 dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-28', 'size': 5201592, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-22T09:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'whyStopped': 'business reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2016-11-21', 'resultsFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-13', 'studyFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to 27 months', 'description': 'Number of participants who experienced an AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment'}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)', 'timeFrame': 'Up to 24 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.'}, {'measure': 'Number of Participants Who Experienced Dose-Limiting Toxicity (DLT)', 'timeFrame': 'Cycle 1 (Arms A, B & C: Up to 21 days)', 'description': 'DLT was defined as a treatment-related adverse event (AE) including the following: Grade (Gr) 4 nonhematologic toxicity (not laboratory), Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia or Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with clinically significant bleeding, Gr 3 non-hematological AE with the exception of fatigue lasting \\>3 days despite optimal supportive care, any Gr 3 or Gr 4 nonhematologic laboratory value if medical intervention is required to treat the subject, or abnormality leads to hospitalization or abnormality persists for \\>1 week, Gr 3 or Gr 4 febrile neutropenia, prolonged delay (\\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity, any treatment-related toxicity that causes the subject to discontinue treatment during Cycle 1, missing \\>25% of MK-8353 doses as a result of drug-related AE(s) during the first cycle, Gr 5 toxicity.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator', 'timeFrame': 'Up to 24 months', 'description': 'ORR was defined as the percentage of the participants in the analysis population who have 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, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by Investigator was presented.'}, {'measure': 'Percent Change in Cancer Antigen 125 (CA-125)', 'timeFrame': 'Cycle 1-8 Day 1, and end of treatment/ safety follow-up (30 days after the last dose). Each cycle was 21 days.', 'description': 'CA-125 was the tumour biomarker used to test cancer. Disease progression is indicated by CA-125 tumor marker elevation.'}, {'measure': 'Percent Change in Carcinoembryonic Antigen (CEA)', 'timeFrame': 'Cycle 1-9 Day 1, and end of treatment/ safety follow-up (30 days after the last dose). Each cycle was 21 days', 'description': 'CEA was the tumour biomarker used to test cancer. Disease progression is indicated by CEA tumor marker elevation.'}, {'measure': 'Percent Change in Carbohydrate Antigen (CA19-9)', 'timeFrame': 'Cycle 1-7 Day 1, and end of treatment/ safety follow-up (30 days after the last dose). Each cycle was 21 days.', 'description': 'CA19-9 was the tumour biomarker used to test cancer. Disease progression is indicated by CA19-9 tumor marker elevation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms', 'Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '39276176', 'type': 'RESULT', 'citation': 'Lakhani NJ, Burris H 3rd, Miller WH Jr, Huang M, Chen LC, Siu LL. A phase 1b study of the ERK inhibitor MK-8353 plus pembrolizumab in patients with advanced solid tumors. Invest New Drugs. 2024 Oct;42(5):581-589. doi: 10.1007/s10637-024-01461-z. Epub 2024 Sep 14.'}], 'seeAlsoLinks': [{'url': 'http://merckoncologyclinicaltrials.com', 'label': 'Merck Oncology Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability and preliminary efficacy of MK-8353 when administered in combination with pembrolizumab (MK-3475). There are two parts in this study: Part 1 will be dose escalation and confirmation, and Part 2 will be a cohort expansion. In Part 1, the recommended phase II dose (RP2D) of MK-8353 in combination with a fixed dose of pembrolizumab in participants with advanced malignancies will be identified and confirmed. Participants will be initially enrolled to receive MK-8353 at 350 mg twice a day (BID) in combination with pembrolizumab at a fixed dose of 200 mg on Day 1 of each 3-week cycle (Q3W) for up to 24 months of treatment. In Part 2, participants with advanced colorectal cancer (CRC) that is microsatellite stable (i.e., non-microsatellite instability-high/deficient mismatch repair \\[non-MSI-H/dMMR\\]) who received at least one and up to five prior lines of therapy will be enrolled at the RP2D in the expansion cohort to further evaluate safety and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part 1: Has a histologically- or cytologically-documented, locally-advanced or metastatic solid malignancy and has received ≥1 and \\<6 prior line of cancer treatment regimen(s).\n* Part 2: Has a histologically-confirmed adenocarcinoma originating from the colon or rectum (Stage 4 American Joint Committee on Cancer \\[AJCC\\] 7th edition) that is microsatellite stable (i.e., non-MSI-H/dMMR). Appendiceal cancer is included AND Has experienced disease progression or was intolerant to at least 1 and up to 5 systemic chemotherapy regimen(s) for metastatic CRC that must have included fluroropyrimidines and irinotecan or oxaliplatin, ± anti-vascular endothelial growth factor (VEGF) or anti-epidermal growth factor receptor (EGFR)(if indicated by RAS mutational status).\n* Provides an archival or newly obtained tumor tissue sample and blood samples for biomarker analysis.\n* Has ≥1 measurable lesion as defined by RECIST 1.1 on imaging studies.\n* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n* Has adequate organ function\n* Female participants of childbearing potential who are willing to use either 2 adequate barrier methods, or to abstain from heterosexual activity throughout the study.\n* Male participants of childbearing potential must agree to use an adequate method of contraception.\n\nExclusion Criteria:\n\n* Has disease that is suitable for local treatment administered with curative intent.\n* Part 1: Has received prior therapy with cancer vaccines, or compounds targeting PD-1 (including Merck pembrolizumab \\[MK-3475\\]), programmed cell death ligand 1 (PD-L1), PD-L2, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), or Mitogen-activated protein kinase (MAPK)/Extracellular signal-regulated Kinase (MEK).\n* Part 2: Has received prior therapy with cancer vaccines, or compounds targeting PD-1 (including Merck pembrolizumab \\[MK-3475\\]), PD-L1, PD-L2, CTLA-4, lymphocyte-activation gene 3 (LAG-3), CD-137, OX-40 (tumor necrosis factor receptor superfamily, member 4 \\[TNFRSF4\\], also known as CD134), cluster of differentiation 40 (CD-40), glucocorticoid-induced TNFR-related protein (GITR), serine/threonine-protein kinase B-Raf (BRAF), MEK or other molecules in the MAPK pathway.\n* Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of study drug.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has had a prior anticancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or has not recovered (i.e. ≤ Grade 1 or at Baseline) from adverse events (AEs) due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from AEs due to a previously administered agent.\n* Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors within 4 weeks prior to study Day 1.\n* Has a known additional malignancy that is progressing or requires active treatment.\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Has a history of interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n* Has a known history of Human Immunodeficiency Virus (HIV).\n* Has known active Hepatitis B or Hepatitis C.\n* Has received a live-virus vaccination within 30 days of planned treatment start.\n* Has had an allogenic tissue/solid organ transplant.'}, 'identificationModule': {'nctId': 'NCT02972034', 'briefTitle': 'Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase Ib Study to Evaluate the Safety and Tolerability of MK-8353 in Combination With Pembrolizumab in Patients With Advanced Malignancies', 'orgStudyIdInfo': {'id': '8353-013'}, 'secondaryIdInfos': [{'id': 'MK-8353-013', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': '2016-003478-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: MK-8353 BID Continuous+Pembro', 'description': 'Participants receive MK-8353 orally (PO) two times each day (BID) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab (pembro) 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Drug: MK-8353', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'B: MK-8353 QD Continuous+Pembro', 'description': 'Participants receive MK-8353 PO once each day (QD) on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.', 'interventionNames': ['Drug: MK-8353', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'C: MK-8353 QD 1 Week On/1 Week Off+Pembro', 'description': 'Optional Arm: Participants receive MK-8353 PO QD on Days 1 to 7, Days 15 to 21 and Days 29 to 35 PLUS pembrolizumab 200 mg IV on Day 1 and Day 22 of each 42-day period (based on 2 cycles of 21 days) for up to 35 cycles.', 'interventionNames': ['Drug: MK-8353', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'D: MK-8353 QD Run-in→MK-8353 QD Continuous+Pembro', 'description': 'Optional Arm: Participants undergo an MK-8353 PO QD run-in period from Day -14 to Day -1 prior to Cycle 1 during which they receive MK-8353 PO QD. After the run-in period, participants receive MK-8353 PO QD on Days 1 through 21 of each 21-day cycle PLUS pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 36 cycles.', 'interventionNames': ['Drug: MK-8353', 'Biological: Pembrolizumab']}], 'interventions': [{'name': 'MK-8353', 'type': 'DRUG', 'description': 'PO capsule', 'armGroupLabels': ['A: MK-8353 BID Continuous+Pembro', 'B: MK-8353 QD Continuous+Pembro', 'C: MK-8353 QD 1 Week On/1 Week Off+Pembro', 'D: MK-8353 QD Run-in→MK-8353 QD Continuous+Pembro']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475'], 'description': 'IV infusion', 'armGroupLabels': ['A: MK-8353 BID Continuous+Pembro', 'B: MK-8353 QD Continuous+Pembro', 'C: MK-8353 QD 1 Week On/1 Week Off+Pembro', 'D: MK-8353 QD Run-in→MK-8353 QD Continuous+Pembro']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Call for Information (Investigational Site 0002)', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Call for Information (Investigational Site 0001)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'H9H 4M7', 'city': 'Kirkland', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Merck Canada', 'geoPoint': {'lat': 45.45008, 'lon': -73.86586}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}