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 laboratory abnormalities approximately 3 years Number of participants with Adverse Events (AEs) approximately 3 years Number of Deaths approximately 3 years Duration of Response (DOR) 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
Trial Locations
- Locations (81)
Local Institution - 0002
🇦🇺Sydney, New South Wales, Australia
Local Institution - 0088
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0150
🇯🇵Shinjuku-Ku, Tokyo, Japan
Local Institution - 0009
🇦🇷Caba, Buenos Aires, Argentina
Local Institution - 0097
🇦🇹Linz, Austria
Local Institution - 0098
🇦🇹Wels, Austria
Local Institution - 0072
🇨🇱Vina del Mar, Valparaiso, Chile
Local Institution - 0161
🇯🇵Sapporo-city, Hokkaido, Japan
Local Institution - 0157
🇯🇵Hirakata, Osaka, Japan
Local Institution - 0159
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Local Institution - 0162
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0051
🇷🇺Moscow, Russian Federation
Local Institution - 0105
🇩🇪Koeln, Germany
Local Institution - 0099
🇦🇹Wien, Austria
Local Institution - 0107
🇦🇷Cordoba, Argentina
Local Institution - 0048
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0104
🇦🇹Salzburger, Austria
Local Institution - 0050
🇧🇷Uberlandia, Minas Gerais, Brazil
Local Institution - 0012
🇨🇦Rimouski, Quebec, Canada
Local Institution - 0049
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0017
🇨🇦Toronto, Ontario, Canada
Local Institution - 0093
🇩🇪Jena, Germany
Local Institution - 0095
🇩🇪Trier, Germany
Local Institution - 0108
🇫🇷Marseille Cedex 05, France
Local Institution - 0103
🇫🇷Paris Cedex 14, France
Local Institution - 0111
🇫🇷Paris Cedex 18, France
Local Institution - 0040
🇫🇷Villejuif, France
Local Institution - 0062
🇮🇹Milano, Italy
Local Institution - 0063
🇮🇹Modena, Italy
Local Institution - 0032
🇬🇷Thessaloniki, Greece
Local Institution - 0067
🇮🇹Torino, TO, Italy
Local Institution - 0064
🇮🇹Napoli, Italy
Local Institution - 0065
🇮🇹Reggio Emilia, Italy
Local Institution - 0066
🇮🇹Roma, Italy
Local Institution - 0151
🇯🇵Kashihara-shi, Nara, Japan
Local Institution - 0149
🇯🇵Tsukuba-shi, Ibaraki, Japan
Local Institution - 0083
🇸🇪Umea, Sweden
Local Institution - 0153
🇯🇵Yokohama City, Kanagawa, Japan
Local Institution - 0164
🇯🇵Nagasaki-shi, Nagasaki, Japan
Local Institution - 0145
🇯🇵Wakayama, Japan
Local Institution - 0059
🇪🇸Sabadell, Spain
Local Institution - 0061
🇪🇸Badajoz, Spain
Local Institution - 0060
🇪🇸Badalona-barcelona, Spain
Local Institution - 0087
🇸🇪Norrkoping, Sweden
Local Institution - 0058
🇪🇸València, Spain
Local Institution - 0057
🇪🇸Santander, Spain
Local Institution - 0055
🇪🇸Madrid, Spain
Local Institution - 0106
🇫🇷DIJON Cedex, France
Local Institution - 0045
🇫🇷Lille, France
Local Institution - 0084
🇺🇸Bronx, New York, United States
Local Institution - 0008
🇦🇷Viedma, RIO Negro, Argentina
Local Institution - 0080
🇦🇷Buenos Aires, Argentina
Local Institution - 0001
🇦🇺Woolloongabba, Queensland, Australia
Local Institution - 0042
🇫🇷Angers Cedex 10, France
Local Institution - 0037
🇨🇦Montreal, Quebec, Canada
Local Institution - 0114
🇦🇺Bowral, Australia
Local Institution - 0011
🇨🇱La Serena, Coquimbo, Chile
Local Institution - 0041
🇫🇷Strasbourg, France
Local Institution - 0094
🇩🇪Herne, Germany
Local Institution - 0074
🇮🇱Ramat-gan, Israel
Local Institution - 0156
🇯🇵Kurashiki-shi, Okayama, Japan
Local Institution
🇳🇱Rotterdam, Netherlands
The University Of Chicago
🇺🇸Chicago, Illinois, United States
Local Institution - 0016
🇦🇷Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
Local Institution - 0047
🇧🇷Itajai, Santa Catarina, Brazil
Local Institution - 0038
🇨🇦Montreal, Quebec, Canada
Local Institution - 0010
🇨🇱Recoleta, Metropolitana, Chile
Local Institution - 0031
🇬🇷Haidari, Greece
Local Institution - 0073
🇮🇱Jerusalem, Israel
Local Institution - 0155
🇯🇵Kobe-shi, Hyogo, Japan
Local Institution - 0146
🇯🇵Kawasaki-shi, Kanagawa, Japan
Local Institution - 0165
🇯🇵Niigata-shi, Niigata, Japan
Local Institution - 0160
🇯🇵Takatsuki-shi, Osaka, Japan
Local Institution - 0081
🇦🇷Mar Del Plata, Buenos Aires, Argentina
Local Institution - 0075
🇮🇱Tel Aviv, Tel-Aviv, Israel
Local Institution - 0147
🇯🇵Nagakute-shi, Aichi, Japan
Local Institution - 0158
🇯🇵Hirosaki-shi, Aomori, Japan
Local Institution - 0154
🇯🇵Osakasayamashi, Osaka, Japan
Local Institution - 0054
🇳🇱Arnhem, Netherlands
Local Institution - 0052
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0096
🇪🇸Pamplona, Navarra, Spain