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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: 19 November, 2020   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3


  • Gender(s)

  • 18+

    Age Range

  • 69


  • Recruiting

Treatment Options

Study Arms
Experimental: Arm A: nivolumab
Biological: Bacillus Calmette-Guérin (BCG) Drug: nivolumab
Placebo Comparator: Arm B: placebo +BCG
Biological: Bacillus Calmette-Guérin (BCG) Other: Placebo

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion: - Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma - 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) - Sufficient tissue for both biomarker analysis and central pathology review committee (PRC) confirmation of diagnosis - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 - Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to follow contraceptive requirements 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 - Prior surgery (other than transurethral resection of the bladder tumor (TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic chemotherapy or immunotherapy for bladder cancer or UC Other inclusion/exclusion criteria apply.

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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