TerminatedPhase 3

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: Insufficient enrollment, inability to meet protocol objectives, and slow accrual.

United States, Argentina13 participantsStarted 2020-01-15

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Part 2: Event Free Survival

Timeframe: Approximately 44 Months and 1 Week

Trial details

NCT IDNCT04149574

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-31

Results submitted2024-10-09

View on ClinicalTrials.gov More Urinary Bladder Neoplasms trials