A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Running, not enrolling · Phase 3

Conditions studied: Urinary Bladder Neoplasms, Muscle-Invasive Bladder Cancer

In brief

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Key facts

Study ID

NCT03661320

Run by

Bristol-Myers Squibb

People needed

855

Starts

2018-11-06

Expected to finish

2027-12-30

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

You may not qualify if…

• Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
• Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

Where it is running

• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• Local Institution - 0021 — Littleton, Colorado, United States
• Local Institution - 0036 — Pensacola, Florida, United States
• Local Institution - 0004 — Tampa, Florida, United States
• Local Institution - 0144 — Atlanta, Georgia, United States
• Local Institution - 0005 — Chicago, Illinois, United States
• Local Institution - 0006 — Peoria, Illinois, United States
• Local Institution - 0181 — Columbia, Maryland, United States
• Local Institution - 0009 — Boston, Massachusetts, United States
• Local Institution - 0166 — Boston, Massachusetts, United States
• Local Institution - 0209 — Boston, Massachusetts, United States
• Local Institution - 0025 — Minneapolis, Minnesota, United States
• Local Institution - 0129 — Minneapolis, Minnesota, United States
• Local Institution - 0183 — Omaha, Nebraska, United States
• Local Institution - 0001 — Omaha, Nebraska, United States
• Local Institution - 0024 — Las Vegas, Nevada, United States
• Local Institution - 0029 — Albany, New York, United States
• Local Institution - 0069 — Lake Success, New York, United States
• Local Institution - 0047 — New York, New York, United States
• Local Institution - 0191 — Cleveland, Ohio, United States
• Local Institution - 0028 — Tigard, Oregon, United States
• Local Institution - 0189 — Charleston, South Carolina, United States
• Local Institution - 0007 — Nashville, Tennessee, United States
• Local Institution - 0030 — Austin, Texas, United States
• Local Institution - 0022 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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