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
Stopped early · Phase 2
Conditions studied: Urinary Bladder Neoplasms
In brief
A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.
Key facts
- Study ID
- NCT03519256
- Run by
- Bristol-Myers Squibb
- People needed
- 142
- Starts
- 2018-08-02
- Expected to finish
- 2022-08-24
- Last updated by the study team
- 2023-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 apply
Where it is running
- Local Institution - 0081 — Riverside, California, United States
- Local Institution - 0087 — San Francisco, California, United States
- Local Institution - 0125 — Tampa, Florida, United States
- Local Institution - 0056 — Hapeville, Georgia, United States
- Local Institution - 0023 — New Lenox, Illinois, United States
- Wichita Urology Group — Wichita, Kansas, United States
- Local Institution - 0001 — Baltimore, Maryland, United States
- Local Institution - 0077 — Ann Arbor, Michigan, United States
- Local Institution - 0032 — Minneapolis, Minnesota, United States
- Local Institution - 0040 — Omaha, Nebraska, United States
- Local Institution - 0144 — New Brunswick, New Jersey, United States
- Deleware Valley Urology, LLC — Voorhees Township, New Jersey, United States
- Local Institution - 0051 — New York, New York, United States
- Local Institution - 0058 — Columbus, Ohio, United States
- Local Institution - 0036 — Bala-Cynwyd, Pennsylvania, United States
- Local Institution - 0049 — Charleston, South Carolina, United States
- Local Institution - 0002 — Myrtle Beach, South Carolina, United States
- Local Institution - 0057 — Chattanooga, Tennessee, United States
- Urology Clinics Of North Texas, Pa — Dallas, Texas, United States
- Local Institution - 0048 — Houston, Texas, United States
- Local Institution - 0140 — Houston, Texas, United States
- Local Institution - 0047 — Lubbock, Texas, United States
- Urology San Antonio Research, Pa — San Antonio, Texas, United States
- Local Institution - 0141 — Seattle, Washington, United States
- Local Institution - 0044 — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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