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Active, Not Recruiting

A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney - CA209-914

Updated: 6 February, 2023   |   ClinicalTrials.gov

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part A, Arm A: nivolumab + ipilimumab
Placebo Comparator: Part A, Arm B: nivolumab placebo + ipilimumab placebo
Experimental: Part B, Arm A: nivolumab + ipilimumab
Placebo Comparator: Part B, Arm B: nivolumab placebo + ipilimumab placebo
Experimental: Part B, Arm C: nivolumab + ipilimumab placebo

Key Eligibility Criteria

Inclusion Criteria: - Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy - Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 - Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features - Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 - Women must agree to follow methods of contraception, if applicable Exclusion Criteria: - Participants with an active known or suspected autoimmune disease - Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways - Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation - History of allergy or hypersensitivity to study drug components - Participants with a condition requiring systemic treatment with corticosteroids - Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol-defined inclusion/exclusion criteria apply

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com