Viewing Study NCT03310957

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Ignite Creation Date: 2025-12-24 @ 7:03 PM
Ignite Modification Date: 2026-02-18 @ 12:49 PM
Study NCT ID: NCT03310957
Status: COMPLETED
Last Update Posted: 2025-12-12
First Post: 2017-10-11
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600157', 'term': 'SGN-LIV1A'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@seagen.com', 'phone': '(855) 473-2436', 'title': 'Chief Medical Officer', 'organization': 'Seagen Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; All-cause mortality, SAEs = maximum up to 30 months)', 'description': 'Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part A.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 5, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part A.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 8, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Part B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 23, 'seriousNumAtRisk': 26, 'deathsNumAffected': 18, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Part B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 47, 'seriousNumAtRisk': 47, 'deathsNumAffected': 31, 'seriousNumAffected': 27}, {'id': 'EG004', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 53, 'seriousNumAtRisk': 53, 'deathsNumAffected': 29, 'seriousNumAffected': 28}, {'id': 'EG006', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part D.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 36, 'seriousNumAtRisk': 37, 'deathsNumAffected': 7, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 26, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 3, 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mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Aortic thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': 'Participants With TEAEs', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}]}, {'title': 'Participants With SAEs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. TEAEs were defined as newly occurring (not present at baseline) or worsened after first dose of investigational product within 30 days after last dose date or within 90 days for SAE. AEs included SAEs and all non-SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Related TEAEs and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': 'Participants With Treatment Related TEAEs', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}]}, {'title': 'Participants With Treatment Related SAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)', 'description': 'An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. AEs included SAEs and all non-SAEs. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. AEs were defined as treatment emergent if they were newly occurring or worsened following study treatment. Relatedness to study drug was assessed by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With AEs of Grade <3 and Grade >=3 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'title': '< Grade 3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': '>= Grade 3', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment up to 30 days for AEs (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months)', 'description': 'An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. AEs severities were graded using the NCI CTCAE v4.03; where Grade 1= mild AE, Grade 2= moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated, Grade 5= indicated death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Hematology Parameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Grade 1', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'Grade 2', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}, {'title': 'Grade 3', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}, {'title': 'Grade 4', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)', 'description': 'In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any hematology parameter are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Hematology parameters evaluated: hemoglobin, leukocytes, lymphocytes, neutrophils and platelets.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Serum Chemistry Parameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'categories': [{'title': 'Grade 1', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}, {'title': 'Grade 2', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Garde 3', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}, {'title': 'Grade 4', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)', 'description': 'In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any serum chemistry parameters are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Serum chemistry parameters evaluated: alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, calcium- ionized, creatinine, gamma glutamyl transferase, glucose, lipase, phosphate, potassium, sodium and urate. In this outcome measure, only those grades as rows are reported which had at least one participant for at least 1 reporting group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLT): Part A and Part C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 milligram per kilogram (mg/kg) by intravenous (IV) infusion on Day 1 of each 21-day cycle every 3 weeks (Q3WK) given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part A.'}, {'id': 'OG001', 'title': 'Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle (Q3WK) given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle every week (Q1WK) by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (up to 21 days)', 'description': 'DLT : hematologic and/or non-hematologic AE specified in protocol that is considered related to SGN-LIV or the combination and cannot be attributed to pembrolizumab alone including: any clinically significant, non-hematologic AE\\>= Grade 3 according to NCI CTCAE v4.03, Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with clinically significant bleeding that required medical intervention, Grade 4 anemia unrelated to underlying disease, discontinuation during Cycle 1 due to treatment-related toxicity/ inability to receive all 3 doses of SGN-LIV (Days 1, 8, and 15) as participant not met dosing criteria (Part C only)prolonged delay (\\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity and Grade 5 event (death).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT-evaluable (DE) analysis included all treated participants in Part A who either (1) experienced a DLT or (2) received at least 75% of intended SGN-LIV1A and pembrolizumab doses and were followed for the full DLT evaluation period. This outcome measure was planned to be analyzed only in Part A and Part C arms.'}, {'type': 'PRIMARY', 'title': 'ORR as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '53.2'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '28.1', 'upperLimit': '54.3'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '47', 'groupId': 'OG003', 'lowerLimit': '33.3', 'upperLimit': '61.4'}, {'value': '39', 'groupId': 'OG004', 'lowerLimit': '23.1', 'upperLimit': '56.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study treatment up to date of confirmed CR or PR (maximum up to 30 months)', 'description': 'ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm. PR: \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Kaplan Meier method was used for analysis.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Per RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '6.9'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '9.9'}, {'value': '4.2', 'comment': 'Upper and lower limit of 95%CI could not be estimated due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.4', 'groupId': 'OG003', 'lowerLimit': '3.6', 'upperLimit': '6.6'}, {'value': '8.3', 'comment': 'Lower limit of 95%CI could not be estimated due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': '5.7', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first CR or PR until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)', 'description': 'DOR = time from first documentation of objective response (subsequently confirmed) per investigator to first documentation of disease progression, or death due to any cause, whichever came first. CR: disappearance of all target lesions. Any pathological lymph nodes (reduction in short axis to \\<10 mm). PR: \\>=30% decrease in sum of diameters of target lesions, taking reference baseline sum diameters. Progression: at least a 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Kaplan-Meier method used for DOR evaluation. DOR was only calculated for subgroup of participants who achieved a confirmed CR or PR.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated analysis set: all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '40.6', 'upperLimit': '76.3'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '69.1', 'upperLimit': '90.3'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '77', 'groupId': 'OG003', 'lowerLimit': '63.8', 'upperLimit': '87.7'}, {'value': '69', 'groupId': 'OG004', 'lowerLimit': '51.9', 'upperLimit': '83.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study treatment up to date of CR or PR or SD (maximum up to 30 months)', 'description': 'DCR was defined as percentage of participants with CR, PR, or stable disease (SD) per RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm. PR: \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (this includes baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Clopper-Pearson method was used for 95% confidence interval.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.1'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.6'}, {'value': '3.3', 'comment': 'Upper limit of 95%CI could not be estimated due to insufficient participants with events.', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': 'NA'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '4.1', 'upperLimit': '5.6'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)', 'description': 'PFS was defined as the time from start of study treatment to first documentation of disease progression based upon the disease assessment per RECISTv1.1 or clinical progression, or to death due to any cause, whichever came first. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions. Kaplan-Meier method was used for PFS evaluation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '26.6'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '25.9'}, {'value': 'NA', 'comment': 'Median and upper -lower limit of 95%CI could not be estimated due to insufficient number of participants with events. Only 1 participant had event with OS of 3.4 months.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '19.4', 'comment': 'Upper limit of 95%CI could not be estimated due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '11.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper and lower limit of 95%CI could not be estimated due to insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment until the date of death, or censoring date, whichever came first (maximum up to 30 months)', 'description': 'OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, OS was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for OS evaluation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated analysis set included all participants who received any amount of SGN-LIV1A or pembrolizumab. As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 milligram per kilogram (mg/kg) by intravenous (IV) infusion on Day 1 of each 21-day cycle every 3 weeks (Q3WK) given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'FG001', 'title': 'Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle (Q3WK) given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part A.'}, {'id': 'FG002', 'title': 'Part B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.'}, {'id': 'FG003', 'title': 'Part B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle (Q3WK) given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle in Part B.'}, {'id': 'FG004', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle every week (Q1WK) by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.'}, {'id': 'FG005', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle in Part C.'}, {'id': 'FG006', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle twice every 3 weeks (2Q3WK) by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle in Part D.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '53'}, {'groupId': 'FG006', 'numSubjects': '37'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '53'}, {'groupId': 'FG006', 'numSubjects': '37'}]}, {'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'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '53'}, {'groupId': 'FG006', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Site Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '29'}, {'groupId': 'FG006', 'numSubjects': '7'}]}, {'type': 'Discontinuation per sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '12'}]}, {'type': 'Discontinuation per protocol amendment 11', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'Treatment landscape', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Alanine aminotransferase (ALT) increased', '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'}]}, {'type': 'Elevated Aspartate aminotransferase (AST)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Hospice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Progressive', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 185 participants were enrolled at multiple sites.', 'preAssignmentDetails': 'Participants were enrolled into Part A, Part B, Part C, and Part D sequentially.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '185', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.0 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG001', 'title': 'Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 2.5 mg/kg by IV infusion on Day 1 of each 21-day cycle Q3WK given over approximately 30 minutes followed by Pembrolizumab 200 mg IV as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG002', 'title': 'Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.0 mg/kg on Day 1, Day 8, and Day 15 in every 3-week cycle Q1WK by IV infusion given over approximately 30 minutes followed by pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG003', 'title': 'Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab', 'description': 'Participants received 1.25 mg/kg on Day 1, 8 and 15 of every 21-day cycle by IV infusion given over approximately 30 minutes followed by 200 mg Pembrolizumab as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG004', 'title': 'Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab', 'description': 'Participants received SGN-LIV 1.5 mg/kg on Day 1 and Day 8 of every 21-day cycle 2Q3WK by IV infusion given over approximately 30 minutes followed by Pembrolizumab 200 mg as a 30-minute infusion on Day 1 of each 21-day cycle.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '55.2', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '45.0', 'spread': '14.1', 'groupId': 'BG002'}, {'value': '57.6', 'spread': '12.7', 'groupId': 'BG003'}, {'value': '54.6', 'spread': '11.0', 'groupId': 'BG004'}, {'value': '55.4', 'spread': '12.3', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '185', 'groupId': 'BG005'}]}, {'title': 'Male', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '148', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '127', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race is reported.', 'unitOfMeasure': 'Participants', 'populationDescription': 'As pre-specified in the SAP, data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}], 'populationDescription': 'As pre-specified in the statistical analysis plan (SAP), data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-19', 'size': 17407453, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-23T09:59', 'hasProtocol': True}, {'date': '2024-05-01', 'size': 3069372, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-23T10:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2017-10-11', 'resultsFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2017-10-11', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-01', 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. TEAEs were defined as newly occurring (not present at baseline) or worsened after first dose of investigational product within 30 days after last dose date or within 90 days for SAE. AEs included SAEs and all non-SAEs.'}, {'measure': 'Number of Participants With Treatment Related TEAEs and SAEs', 'timeFrame': 'From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)', 'description': 'An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. AEs included SAEs and all non-SAEs. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. AEs were defined as treatment emergent if they were newly occurring or worsened following study treatment. Relatedness to study drug was assessed by the investigator.'}, {'measure': 'Number of Participants With AEs of Grade <3 and Grade >=3 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03', 'timeFrame': 'From start of study treatment up to 30 days for AEs (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months)', 'description': 'An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. AEs severities were graded using the NCI CTCAE v4.03; where Grade 1= mild AE, Grade 2= moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated, Grade 5= indicated death related to AE.'}, {'measure': 'Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Hematology Parameter', 'timeFrame': 'Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)', 'description': 'In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any hematology parameter are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Hematology parameters evaluated: hemoglobin, leukocytes, lymphocytes, neutrophils and platelets.'}, {'measure': 'Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Serum Chemistry Parameter', 'timeFrame': 'Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)', 'description': 'In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any serum chemistry parameters are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Serum chemistry parameters evaluated: alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, calcium- ionized, creatinine, gamma glutamyl transferase, glucose, lipase, phosphate, potassium, sodium and urate. In this outcome measure, only those grades as rows are reported which had at least one participant for at least 1 reporting group.'}, {'measure': 'Number of Participants With Dose Limiting Toxicities (DLT): Part A and Part C', 'timeFrame': 'Cycle 1 (up to 21 days)', 'description': 'DLT : hematologic and/or non-hematologic AE specified in protocol that is considered related to SGN-LIV or the combination and cannot be attributed to pembrolizumab alone including: any clinically significant, non-hematologic AE\\>= Grade 3 according to NCI CTCAE v4.03, Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with clinically significant bleeding that required medical intervention, Grade 4 anemia unrelated to underlying disease, discontinuation during Cycle 1 due to treatment-related toxicity/ inability to receive all 3 doses of SGN-LIV (Days 1, 8, and 15) as participant not met dosing criteria (Part C only)prolonged delay (\\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity and Grade 5 event (death).'}, {'measure': 'ORR as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1', 'timeFrame': 'From start of study treatment up to date of confirmed CR or PR (maximum up to 30 months)', 'description': 'ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm. PR: \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Kaplan Meier method was used for analysis.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DOR) Per RECIST v1.1', 'timeFrame': 'From the date of first CR or PR until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)', 'description': 'DOR = time from first documentation of objective response (subsequently confirmed) per investigator to first documentation of disease progression, or death due to any cause, whichever came first. CR: disappearance of all target lesions. Any pathological lymph nodes (reduction in short axis to \\<10 mm). PR: \\>=30% decrease in sum of diameters of target lesions, taking reference baseline sum diameters. Progression: at least a 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Kaplan-Meier method used for DOR evaluation. DOR was only calculated for subgroup of participants who achieved a confirmed CR or PR.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'From start of study treatment up to date of CR or PR or SD (maximum up to 30 months)', 'description': 'DCR was defined as percentage of participants with CR, PR, or stable disease (SD) per RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm. PR: \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (this includes baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Clopper-Pearson method was used for 95% confidence interval.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From start of study treatment until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)', 'description': 'PFS was defined as the time from start of study treatment to first documentation of disease progression based upon the disease assessment per RECISTv1.1 or clinical progression, or to death due to any cause, whichever came first. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions. Kaplan-Meier method was used for PFS evaluation.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From start of study treatment until the date of death, or censoring date, whichever came first (maximum up to 30 months)', 'description': 'OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, OS was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for OS evaluation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Breast carcinoma', 'Triple negative breast cancer', 'Locally-advanced breast cancer', 'Metastatic breast cancer', 'Tumors, breast', 'Breast tumors', 'pembrolizumab', 'LIV-1 protein, human', 'Ladiratuzumab vedotin', 'hLIV22-vcMMAE', 'Seattle Genetics'], 'conditions': ['Triple Negative Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.', 'detailedDescription': 'The primary goal of this study is to evaluate the combination of LV, which targets LIV-1- expressing tumor cells, with the checkpoint inhibitor pembrolizumab for patients with unresectable locally-advanced or metastatic triple-negative breast cancer. These two drugs act through distinct and possibly complementary modes of action.\n\nThis is a single-arm, open-label, multicenter trial. Patients given LV and pembrolizumab during dose escalation will be monitored for frequency of dose-limiting toxicities to determine a recommended doses for expansion cohorts. In addition to safety measures, objective response rate, progression-free survival, overall survival, and other efficacy outcomes will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)\n\n * Part D only: Tumor tissue PD-L1 Combined Positive Score \\<10 expression.\n* Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer\n* At least 6 months since prior treatment with curative intent and recurrence\n* At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Able to provide biopsy tissue for biomarker analysis\n* Meet baseline laboratory data criteria\n\nExclusion Criteria:\n\n* Prior immune-oncology therapy\n* Pre-existing neuropathy of at least Grade 2\n* History of carcinomatous meningitis or active central nervous system (CNS) metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. Patients must be off corticosteroids.\n* Received prior radiotherapy within 2 weeks of start of study treatment or have not adequately recovered from prior radiotherapy\n* Active autoimmune disease requiring systemic treatment within the past 2 years\n* History of interstitial lung disease\n* Current pneumonitis or history of pneumonitis requiring steroids'}, 'identificationModule': {'nctId': 'NCT03310957', 'briefTitle': 'Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seagen Inc.'}, 'officialTitle': 'Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'SGNLVA-002'}, 'secondaryIdInfos': [{'id': 'KEYNOTE 721', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}, {'id': '2017-002289-35', 'type': 'EUDRACT_NUMBER'}, {'id': 'MK-3475-721', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LV + pembrolizumab', 'description': 'LV + pembrolizumab', 'interventionNames': ['Drug: ladiratuzumab vedotin', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'ladiratuzumab vedotin', 'type': 'DRUG', 'otherNames': ['LV', 'SGN-LIV1A'], 'description': 'Given into the vein (IV; intravenously)', 'armGroupLabels': ['LV + pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['KEYTRUDA®'], 'description': 'IV infusion every 3 weeks', 'armGroupLabels': ['LV + pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine - Newport', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers - Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06856', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Whittingham Cancer Center / Norwalk Hospital', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Helen F. 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