NCT03519256 | Study Connect

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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: 16 November, 2020 | ClinicalTrials.gov

About This Trial
Key Eligibility Criteria
Trial Site Locations

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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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SELECT LANGUAGE

Trial Details

Phase 2

Phase
Gender(s)
18+

Age Range
62

Location(s)
Recruiting

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Experimental: Nivolumab + BCG

Biological: BCG Biological: Nivolumab

Experimental: Nivolumab + BMS-986205

Biological: Nivolumab Drug: BMS-986205

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, carcinoma in situ (CIS)-containing high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component - Participants must have CIS to be eligible. - 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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