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
- Not Recruiting
A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer
18 Years and up
Accepting Healthy Volunteers?
- 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
- 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