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Phase 3
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18+Age Range
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Active, Not Recruiting
Active, Not Recruiting
A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)
A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.
Inclusion Criteria: - Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive - Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC) - Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses) - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 Exclusion Criteria: - Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC - UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment - UC and/or CIS in the prostatic urethra within 12 months of enrollment Other protocol-defined inclusion/exclusion criteria apply
Experimental: Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)
Placebo Comparator: Arm B: placebo +BCG