Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05092360
Status:
TERMINATED
Last Update Posted:
2025-08-28
First Post:
2021-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
Sponsor:
Organization:
Raw JSON
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The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.", 'otherNumAtRisk': 190, 'deathsNumAtRisk': 190, 'otherNumAffected': 171, 'seriousNumAtRisk': 190, 'deathsNumAffected': 105, 'seriousNumAffected': 51}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 102, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 31, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 165, 'numAffected': 64}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 23, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 30, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 38, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 60, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 180, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 65, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 158, 'numAffected': 60}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 56, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 110, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 45, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 40, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 55, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 52, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 101, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 36, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 81, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 69, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 32, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 37, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 50, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 31, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 75, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 162, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 30, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 80, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 64, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 35, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 193, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 60, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 176, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 29, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 88, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 37, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 94, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 53, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 22, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 116, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 56, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 30, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 39, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 34, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Investigations', 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1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'OG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '12.5'}, {'value': '10.1', 'comment': 'Higher limit of 95% CI could not be assessed due to the limited number of participants and death events within this reporting group.', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': 'NA'}, {'value': '10.7', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '13.9'}, {'value': '9.8', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of study drug up to 24 months', 'description': 'Estimates based on Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) as Assessed by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'OG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '14.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '00', 'upperLimit': '12.8'}, {'value': '11.1', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '16.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'Response is based on RECIST v1.1 criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) as Assessed by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'OG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}], 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000', 'lowerLimit': '27.4', 'upperLimit': '41.6'}, {'value': '25.9', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '46.3'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '23.8', 'upperLimit': '50.4'}, {'value': '52.1', 'groupId': 'OG003', 'lowerLimit': '44.8', 'upperLimit': '59.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'Response is based on RECIST v1.1 criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) as Assessed by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'OG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '14.7'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '12.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'Response is based on RECIST v1.1 criteria.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here N refers to number of participants with response and were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) as Assessed by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'OG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '5.7'}, {'value': '1.64', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'Response is based on RECIST v1.1 criteria.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here N refers to number of participants with response and were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cancer Antigen (CA)-125 Response as Defined by the Gynecologic Cancer Inter Group (GCIG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'OG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '12.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '6.5'}, {'value': '13.2', 'groupId': 'OG003', 'lowerLimit': '8.7', 'upperLimit': '18.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'A Cancer Antigen-125 response is defined as at least a 50% reduction in CA-125 levels from baseline, and the response must be confirmed and maintained for at least 28 days as per the GCIG.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'OG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}], 'classes': [{'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 90 days after last dose (up to 23 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set population.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) as Assessed by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'OG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'OG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.7'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.4'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '2.6'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '2.6', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of study drug up to 20 months', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'FG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'FG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'FG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '190'}]}, {'type': 'Intent to Treat Population', 'comment': 'The intent to treat (ITT) Population will include all randomized participants regardless of the study drug received.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '190'}]}, {'type': 'Safety Set Population', 'comment': "The Safety Population included all randomized participants who received any exposure to nemvaleukin, pembrolizumab, or Investigator's choice chemotherapy.", 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '190'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '101'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '61'}]}]}], 'recruitmentDetails': 'The study was conducted globally from 10 Jan 2022 to 08 May 2025.', 'preAssignmentDetails': "Participants with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer were enrolled into 1 of 4 arms to receive nemvaleukin alfa (ALKS 4230) either as monotherapy or in combination with pembrolizumab or in investigator's choice chemotherapy. Study was terminated due to business and strategic decision."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}, {'value': '456', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'BG001', 'title': 'Pembrolizumab 200 mg', 'description': 'Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.'}, {'id': 'BG002', 'title': 'Nemvaleukin 6 mcg/kg', 'description': 'Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.'}, {'id': 'BG003', 'title': "Investigator's Choice Chemotherapy", 'description': "Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.\n\nPegylated Liposomal Doxorubicin (PLD): 40 mg/m\\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).\n\nPaclitaxel: 80 mg/m\\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.\n\nTopotecan: 4 mg/m\\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.\n\nGemcitabine: 1,000 mg/m\\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'spread': '8.83', 'groupId': 'BG000'}, {'value': '61.6', 'spread': '12.97', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '9.17', 'groupId': 'BG002'}, {'value': '61.3', 'spread': '9.99', 'groupId': 'BG003'}, {'value': '61.8', 'spread': '9.63', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}, {'value': '456', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}, {'value': '419', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '326', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-31', 'size': 1259271, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-26T03:31', 'hasProtocol': True}, {'date': '2024-08-19', 'size': 773426, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-26T03:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 456}}, 'statusModule': {'whyStopped': 'Study terminated due to business and strategic decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2021-10-13', 'resultsFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-11', 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the first dose of study drug up to 24 months', 'description': 'Estimates based on Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) as Assessed by Investigator', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'Response is based on RECIST v1.1 criteria.'}, {'measure': 'Disease Control Rate (DCR) as Assessed by Investigator', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'Response is based on RECIST v1.1 criteria.'}, {'measure': 'Duration of Response (DOR) as Assessed by Investigator', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'Response is based on RECIST v1.1 criteria.'}, {'measure': 'Time to Response (TTR) as Assessed by Investigator', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'Response is based on RECIST v1.1 criteria.'}, {'measure': 'Percentage of Participants With Cancer Antigen (CA)-125 Response as Defined by the Gynecologic Cancer Inter Group (GCIG)', 'timeFrame': 'From the first dose of study drug up to 20 months', 'description': 'A Cancer Antigen-125 response is defined as at least a 50% reduction in CA-125 levels from baseline, and the response must be confirmed and maintained for at least 28 days as per the GCIG.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study drug up to 90 days after last dose (up to 23 months)'}, {'measure': 'Progression-free Survival (PFS) as Assessed by Investigator', 'timeFrame': 'From the first dose of study drug up to 20 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PROC', 'EOC', 'ALKS 4230', 'IL-2', 'Ovarian Cancer', 'KEYNOTE-C71', 'Platinum Resistant', 'Epithelian Ovarian Cancer', 'Nemvaleukin alfa', 'Pembrolizumab', 'ARTISTRY-7', 'ART-7', 'paclitaxel', 'pegylated liposoma doxorubicin', 'PLD', 'topotecan', 'gemzar', 'gemcitabine'], 'conditions': ['Platinum-resistant Ovarian Cancer', 'Fallopian Tube Cancer', 'Primary Peritoneal Cancer']}, 'referencesModule': {'references': [{'pmid': '37334673', 'type': 'DERIVED', 'citation': "Herzog TJ, Hays JL, Barlin JN, Buscema J, Cloven NG, Kong LR, Tyagi NK, Lanneau GS, Long BJ, Marsh RL, Seward SM, Starks DC, Welch S, Moore KN, Konstantinopoulos PA, Gilbert L, Monk BJ, O'Malley DM, Chen X, Dalal R, Coleman RL, Sehouli J. ARTISTRY-7: phase III trial of nemvaleukin alfa plus pembrolizumab vs chemotherapy for platinum-resistant ovarian cancer. Future Oncol. 2023 Jul;19(23):1577-1591. doi: 10.2217/fon-2023-0246. Epub 2023 Jun 19."}]}, 'descriptionModule': {'briefSummary': "This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.", 'detailedDescription': "Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either:\n\nArm 1: Nemvaleukin and pembrolizumab combination therapy Arm 2: Pembrolizumab monotherapy Arm 3: Nemvaleukin monotherapy Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is female and ≥18 years of age.\n* Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.\n* Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.\n* Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting. Patient must have received at least 1 line of therapy containing bevacizumab.\n* Patient has at least one measurable lesion that qualifies as a target lesion based on RECISTv1.1.\n* Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.\n\nExclusion Criteria:\n\n* Patient has primary platinum-refractory disease or primary platinum resistance, defined as disease progression during first-line platinum-based therapy (refractory) or disease progression \\<3 months after completion of first-line platinum-based therapy (resistant).\n* Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.\n* Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).\n* Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) of ≥500 mL within 4 weeks of first dose of study drug.\n* Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.\n* Patient has prior exposure to any anti-PD1/PD-L1 therapy.'}, 'identificationModule': {'nctId': 'NCT05092360', 'acronym': 'ARTISTRY-7', 'briefTitle': 'Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mural Oncology, Inc'}, 'officialTitle': "A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)", 'orgStudyIdInfo': {'id': 'ALKS 4230-007'}, 'secondaryIdInfos': [{'id': 'GOG-3063', 'type': 'OTHER', 'domain': 'The GOG Foundation'}, {'id': 'ENGOT-OV68', 'type': 'OTHER', 'domain': 'European Network Gynaecological Oncological Trial groups'}, {'id': 'KEYNOTE-C71', 'type': 'OTHER', 'domain': 'Merck'}, {'id': 'APGOT-OV8', 'type': 'OTHER', 'domain': 'APAC Gynecologic Oncology Trial Group'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nemvaleukin and Pembrolizumab Combination', 'interventionNames': ['Biological: Nemvaleukin and Pembrolizumab Combination']}, {'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab (enrollment completed)', 'interventionNames': ['Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Nemvaleukin (enrollment completed)', 'interventionNames': ['Biological: Nemvaleukin']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Investigator's Choice", 'description': "Options for protocol-specific Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator's choice treatment before the randomization of each patient.", 'interventionNames': ['Drug: Pegylated Liposomal Doxorubicin (PLD)', 'Drug: Paclitaxel', 'Drug: Topotecan', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'Nemvaleukin and Pembrolizumab Combination', 'type': 'BIOLOGICAL', 'otherNames': ['Nemvaleukin alfa', 'ALKS 4230', 'Keytruda'], 'description': 'Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes and Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes', 'armGroupLabels': ['Nemvaleukin and Pembrolizumab Combination']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Keytruda'], 'description': 'Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes', 'armGroupLabels': ['Pembrolizumab (enrollment completed)']}, {'name': 'Nemvaleukin', 'type': 'BIOLOGICAL', 'otherNames': ['Nemvaleukin alfa', 'ALKS 4230'], 'description': 'Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes', 'armGroupLabels': ['Nemvaleukin (enrollment completed)']}, {'name': 'Pegylated Liposomal Doxorubicin (PLD)', 'type': 'DRUG', 'otherNames': ['PLD- CAELYX', 'DOXIL', 'LIPODOX', 'Myocet'], 'description': '40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+)', 'armGroupLabels': ["Investigator's Choice"]}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Nov-Onxol', 'Taxol', 'Onxol', 'Paclitaxel Novaplus'], 'description': '80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min', 'armGroupLabels': ["Investigator's Choice"]}, {'name': 'Topotecan', 'type': 'DRUG', 'otherNames': ['Hycamtin', 'Potactasol'], 'description': '4 mg/m2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min', 'armGroupLabels': ["Investigator's Choice"]}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar', 'Infugem'], 'description': '1,000 mg/m2; 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