A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Urinary Bladder Neoplasms

In brief

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

Key facts

Study ID

NCT04149574

Run by

Bristol-Myers Squibb

People needed

13

Starts

2020-01-15

Expected to finish

2023-10-31

Last updated by the study team

2025-09-16

Who can join

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

You may qualify if…

• Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive
• Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)
• Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

You may not qualify if…

• Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC
• UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
• UC and/or CIS in the prostatic urethra within 12 months of enrollment
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0084 — The Bronx, New York, United States
• Local Institution - 0009 — Caba, Buenos Aires, Argentina
• Local Institution - 0088 — Capital Federal, Buenos Aires, Argentina
• Local Institution - 0016 — Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
• Local Institution - 0081 — Mar del Plata, Buenos Aires, Argentina
• Local Institution - 0008 — Viedma, Río Negro Province, Argentina
• Local Institution - 0080 — Buenos Aires, Argentina
• Local Institution - 0107 — Córdoba, Argentina
• Local Institution - 0002 — Sydney, New South Wales, Australia
• Local Institution - 0001 — Woolloongabba, Queensland, Australia
• Local Institution - 0114 — Bowral, Australia
• Local Institution - 0097 — Linz, Austria
• Local Institution - 0104 — Salzburger, Austria
• Local Institution - 0099 — Vienna, Austria
• Local Institution - 0098 — Wels, Austria
• Local Institution - 0050 — Uberlândia, Minas Gerais, Brazil
• Local Institution - 0048 — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution - 0047 — Itajaí, Santa Catarina, Brazil
• Local Institution - 0049 — Rio de Janeiro, Brazil
• Local Institution - 0017 — Toronto, Ontario, Canada
• Local Institution - 0038 — Montreal, Quebec, Canada
• Local Institution - 0037 — Montreal, Quebec, Canada
• Local Institution - 0012 — Rimouski, Quebec, Canada
• Local Institution - 0011 — La Serena, Coquimbo Region, Chile
• The University Of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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