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Recruiting

A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder - CA209-9UT

Updated: 21 October, 2019   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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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.
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Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 50

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Nivolumab + BCG
Biological: BCG Biological: Nivolumab
Experimental: Nivolumab + BMS-986205
Drug: BMS-986205 Biological: Nivolumab
Experimental: Nivolumab + BMS-986205 + BCG
Drug: BMS-986205 Biological: BCG Biological: Nivolumab
Experimental: Nivolumab monotherapy
Biological: Nivolumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Pathologically demonstrated BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component, any T1, or Ta high-grade lesions - Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Exclusion Criteria: - Sign of locally advanced disease or metastatic bladder cancer - Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment - Prior immuno-oncology therapy Other protocol defined inclusion/exclusion criteria could 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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