Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-01-29 @ 5:43 AM
Study NCT ID:
NCT03873402
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
Sponsor:
Organization:
Raw JSON
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437}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS) by blinded independent central review (BICR)', 'timeFrame': 'Up to 34 months'}, {'measure': 'Objective response rate (ORR) by BICR', 'timeFrame': 'Up to 23 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Overall response rate (ORR) by investigator', 'timeFrame': 'Up to 4 years'}, {'measure': 'Disease control rate (DCR) by investigator', 'timeFrame': 'Up to 4 years'}, {'measure': 'Duration of response (DoR) by investigator', 'timeFrame': 'Up to 4 years'}, {'measure': 'Time to objective response (TTR) by investigator', 'timeFrame': 'Up to 4 years'}, {'measure': 'Progression Free Survival (PFS) by investigator', 'timeFrame': 'Up to 4 years'}, {'measure': 'Progression free survival secondary objective (PFS2) by investigator', 'timeFrame': 'Up to 4 years'}, {'measure': 'Disease control rate (DCR) by BICR', 'timeFrame': 'Up to 4 years'}, {'measure': 'Duration of response (DoR) by BICR', 'timeFrame': 'Up to 4 years'}, {'measure': 'Time to objective response (TTR) by BICR', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of drug-related AEs', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of Severe Adverse Events (SAEs)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of drug-related SAEs', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Hematology tests', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Coagulation tests', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Serology tests', 'timeFrame': 'Up to 4 years'}, {'measure': 'PFS based on gene expression (GEP) signatures', 'timeFrame': 'Up to 4 years'}, {'measure': 'Objective response rate (ORR) based on GEP signatures', 'timeFrame': 'Up to 4 years'}, {'measure': 'OS based on GEP signatures', 'timeFrame': 'Up to 4 years'}, {'measure': 'OS based on programmed cell death protein ligand-1 (PD-L1) expression', 'timeFrame': 'Up to 4 years'}, {'measure': 'ORR by BICR based on PD-L1 expression', 'timeFrame': 'Up to 4 years'}, {'measure': 'PFS by BICR based on PD-L1 expression', 'timeFrame': 'Up to 4 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT03873402.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': 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