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)
- Conditions
- Urinary Bladder Neoplasms
- Interventions
- Registration Number
- NCT04149574
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: nivolumab + Bacillus Calmette-Guérin (BCG) Bacillus Calmette-Guérin (BCG) - Arm B: placebo +BCG Bacillus Calmette-Guérin (BCG) - Arm A: nivolumab + Bacillus Calmette-Guérin (BCG) nivolumab - Arm B: placebo +BCG Placebo -
- Primary Outcome Measures
Name Time Method Event Free Survival (EFS) approximately 3 years
- Secondary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) approximately 3 years Complete Response Rate (CRR) approximately 3 years Number of participants with laboratory changes from baseline approximately 3 years Worsening- Free Survival (WFS) approximately 3 years Overall Survival (OS) approximately 3 years Duration of Response (DOR) approximately 3 years Number of participants with laboratory abnormalities approximately 3 years Number of Deaths approximately 3 years
Trial Locations
- Locations (81)
The University Of Chicago
🇺🇸Chicago, Illinois, United States
Local Institution - 0084
🇺🇸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, RIO Negro, Argentina
Local Institution - 0080
🇦🇷Buenos Aires, Argentina
Local Institution - 0107
🇦🇷Cordoba, Argentina
Local Institution - 0002
🇦🇺Sydney, New South Wales, Australia
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