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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: 15 April, 2019   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participants 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

  • 57

    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
Biological: Nivolumab Drug: BMS-986205 Biological: BCG
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

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