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  • NCT04149574

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) - CA209-7G8

Updated: 5 September, 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: Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)
Drug: nivolumab Biological: Bacillus Calmette-Guérin (BCG)
Placebo Comparator: Arm B: placebo +BCG
Other: Placebo Biological: Bacillus Calmette-Guérin (BCG)

Key Eligibility Criteria

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

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