Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT03062358
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Philippines']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.', 'description': 'All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.', 'eventGroups': [{'id': 'EG000', 'title': 'Pembrolizumab First Course', 'description': 'Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.', 'otherNumAtRisk': 299, 'deathsNumAtRisk': 300, 'otherNumAffected': 272, 'seriousNumAtRisk': 299, 'deathsNumAffected': 263, 'seriousNumAffected': 76}, {'id': 'EG001', 'title': 'Placebo First Course', 'description': 'Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 135, 'seriousNumAtRisk': 153, 'deathsNumAffected': 146, 'seriousNumAffected': 31}, {'id': 'EG002', 'title': 'Pembrolizumab Second Course', 'description': "Eligible participants randomized to the pembrolizumab first course who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 8, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 55, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 76, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 70, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 34, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 37, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 138, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 47, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 162, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 59, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 60, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 142, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 48, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 62, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hepatitis B DNA increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 41, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 98, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 134, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 34, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 128, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 33, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 50, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 28, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 46, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 153, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 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CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with CR or PR.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + BSC', 'description': 'Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}, {'id': 'OG001', 'title': 'Placebo + BSC', 'description': 'Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'groupId': 'OG000', 'lowerLimit': '46.8', 'upperLimit': '58.4'}, {'value': '47.7', 'groupId': 'OG001', 'lowerLimit': '39.6', 'upperLimit': '55.9'}]}]}], 'analyses': [{'pValue': '0.13281', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '14.8', 'estimateComment': 'Difference in % vs Placebo', 'groupDescription': 'Difference in % vs Placebo', 'statisticalMethod': 'One-sided p-value for testing', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'H0: difference in % =0 versus H1: difference in % \\> 0.', 'otherAnalysisDescription': 'Based on Miettinen \\& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 4 years', 'description': 'DCR is the percentage of participants who achieve CR, PR, or stable disease (SD) for ≥5 weeks prior to evidence of disease progression per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants based on the treatment group to which they were randomized, who achieved CR, PR, or SD for ≥5 weeks prior to evidence of disease progression.'}, {'type': 'SECONDARY', 'title': 'Time To Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + BSC', 'description': 'Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}, {'id': 'OG001', 'title': 'Placebo + BSC', 'description': 'Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.8'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.8'}]}]}], 'analyses': [{'pValue': '0.0019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.90', 'pValueComment': 'Log-rank test', 'estimateComment': "Based on Cox regression model with Efron's method of tie handling with treatment as a covariate", 'statisticalMethod': 'One-sided p-value', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined', 'otherAnalysisDescription': 'Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4 years', 'description': 'TTP is the time from randomization to first documented disease progression per RECIST 1.1 by BICR, based on Kaplan-Meier method for censored data.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants based on the treatment group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced At Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + BSC', 'description': 'Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}, {'id': 'OG001', 'title': 'Placebo + BSC', 'description': 'Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}], 'classes': [{'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 30 months.', 'description': 'An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + BSC', 'description': 'Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}, {'id': 'OG001', 'title': 'Placebo + BSC', 'description': 'Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 27 months.', 'description': 'An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pembrolizumab + BSC', 'description': 'Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus best supportive care (BSC).'}, {'id': 'FG001', 'title': 'Placebo + BSC', 'description': 'Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All randomized participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'Treated', 'comment': 'First Course Pembrolizumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'Second Course', 'comment': 'Second Course Pembrolizumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '153'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '269'}, {'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Male and female participants at least 18 years of age with advanced hepatocellular carcinoma (HCC) after progression on or intolerance to sorafenib or oxaliplatin-based chemotherapy with no curative option were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pembrolizumab + BSC', 'description': 'Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}, {'id': 'BG001', 'title': 'Placebo + BSC', 'description': 'Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '53.7', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Macrovascular Invasion', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Per Case Report Form', 'unitOfMeasure': 'Participants'}, {'title': 'Alpha-Fetoprotein (α-Fetoprotein)', 'classes': [{'title': '< 200 ng/mL', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}, {'title': '≥ 200 ng/mL', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Per Lab', 'unitOfMeasure': 'Participants'}, {'title': 'Region', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '255', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}, {'title': 'Ex-China', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'China comprises: China mainland, Hong Kong, and Taiwan; Ex-China comprises: South Korea and Malaysia.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-03', 'size': 3174038, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-11T11:03', 'hasProtocol': True}, {'date': '2021-06-22', 'size': 470338, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-07T10:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 453}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2017-02-21', 'resultsFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-06-07', 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 4 years', 'description': 'OS is the time from randomization to death due to any cause, based on the Kaplan-Meier method for censored data.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 4 years', 'description': 'PFS is the time from randomization to first documented disease progression or death due to any cause per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) based on the Kaplan-Meier method for censored data.'}, {'measure': 'Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 4 years', 'description': 'ORR is the percentage of participants who achieve complete response (CR) or partial response (PR) with confirmation per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.'}, {'measure': 'Duration Of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DOR is the time from first documented evidence of CR or PR per RECIST 1.1 by BICR until disease progression per RECIST 1.1 by BICR or death, based on Kaplan-Meier method for censored data. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.'}, {'measure': 'Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DCR is the percentage of participants who achieve CR, PR, or stable disease (SD) for ≥5 weeks prior to evidence of disease progression per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.'}, {'measure': 'Time To Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 4 years', 'description': 'TTP is the time from randomization to first documented disease progression per RECIST 1.1 by BICR, based on Kaplan-Meier method for censored data.'}, {'measure': 'Number of Participants Who Experienced At Least One Adverse Event (AE)', 'timeFrame': 'Up to approximately 30 months.', 'description': 'An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 27 months.', 'description': 'An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death Receptor 1 (PD-1)', 'Programmed Cell Death Receptor Ligand 1 (PD-L1)', 'Programmed Cell Death Receptor Ligand 2 (PD-L2)', 'PD1', 'PD-1', 'PDL1', 'PD-L1', 'PDL2'], 'conditions': ['Carcinoma, Hepatocellular']}, 'referencesModule': {'references': [{'pmid': '36455168', 'type': 'BACKGROUND', 'citation': 'Qin S, Chen Z, Fang W, Ren Z, Xu R, Ryoo BY, Meng Z, Bai Y, Chen X, Liu X, Xiao J, Ho GF, Mao Y, Wang X, Ying J, Li J, Zhong W, Zhou Y, Siegel AB, Hao C. Pembrolizumab Versus Placebo as Second-Line Therapy in Patients From Asia With Advanced Hepatocellular Carcinoma: A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2023 Mar 1;41(7):1434-1443. doi: 10.1200/JCO.22.00620. Epub 2022 Dec 1.'}, {'pmid': '40486134', 'type': 'DERIVED', 'citation': 'Finn RS, Gu K, Chen X, Merle P, Lee KH, Bouattour M, Cao P, Wang W, Cheng AL, Zhu L, Lim HY, Kudo M, Pan Y, Chang TT, Edeline J, Li W, Yang P, Li C, Li J, Siegel AB, Qin S. Second-line pembrolizumab for advanced HCC: Meta-analysis of the phase III KEYNOTE-240 and KEYNOTE-394 studies. JHEP Rep. 2025 Feb 4;7(6):101350. doi: 10.1016/j.jhepr.2025.101350. eCollection 2025 Jun.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of pembrolizumab or placebo given with best supportive care (BSC) in Asian participants with previously systemically treated advanced hepatocellular carcinoma (HCC). The primary hypothesis of this study is that overall survival is prolonged in participants who receive pembrolizumab compared to those who receive placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar, and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible)\n* Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy and not amenable to a curative treatment approach.\n* Has a Child-Pugh A liver score within 7 days prior to first dose of study medication\n* Has a life expectancy of \\>3 months\n* Has at least one measurable lesion based on RECIST version 1.1 as determined by investigator.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 7 days prior to receiving the first dose of study medication.\n* Has documented objective radiographic progression during or after treatment with sorafenib or oxaliplatin-based chemotherapy, or else intolerance to sorafenib or oxaliplatin-based chemotherapy\n* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy\n* Female and male participants of reproductive potential must agree to use adequate contraception starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication\n\nExclusion Criteria:\n\n* Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study medication\n* Has received sorafenib or oxaliplatin-based chemotherapy within 14 days of first dose of study medication\n* Has had esophageal or gastric variceal bleeding within the last 6 months\n* Has clinically apparent ascites on physical examination\n* Has portal vein invasion at the main portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging\n* Has had clinically diagnosed hepatic encephalopathy in the last 6 months\n* Has had a solid organ or hematologic transplant\n* Has had prior systemic therapy for HCC in the advanced (incurable) setting other than sorafenib or oxaliplatin-based chemotherapy, prior to start of study medication\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication\n* Has received locoregional therapy to liver (transcatheter chemoembolization \\[TACE\\], transcatheter embolization \\[TAE\\], hepatic arterial infusion \\[HAI\\], radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study medication\n* Has had major surgery to liver or other site within 4 weeks prior to the first dose of study medication\n* Has had a minor surgery ≤7 days prior to the first dose of study medication\n* Has not recovered adequately (i.e., Grade ≤1 or baseline) from the toxicity and/or complications from any intervention prior to study start\n* Has a diagnosed additional malignancy within 3 years prior to first dose of study medication with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers\n* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n* Has an active infection requiring systemic therapy\n* Is pregnant or breast feeding or expecting to conceive or father starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication\n* Has received prior immunotherapy with an anti-Programmed Cell Death Receptor 1 (PD-1), Programmed Cell Death Receptor Ligand 1 (anti-PD-L1), or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) or has previously participated in clinical studies with pembrolizumab\n* Has a known history of human immunodeficiency virus (HIV)\n* Has untreated active Hepatitis B\n* Has Hepatitis C in which participants received therapy for HCV \\<4 weeks prior to receiving pembrolizumab\n* Has received a live vaccine within 30 days prior to the first dose of study therapy'}, 'identificationModule': {'nctId': 'NCT03062358', 'briefTitle': 'Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III Randomized Double-blind Study of Pembrolizumab Plus Best Supportive Care vs. Placebo Plus Best Supportive Care as Second-Line Therapy in Asian Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-394)', 'orgStudyIdInfo': {'id': '3475-394'}, 'secondaryIdInfos': [{'id': 'MK-3475-394', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pembrolizumab + BSC', 'description': 'Participants receive 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