Bladder Cancer Clinical Trial
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)
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.
Eligibility Criteria
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
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There are 82 Locations for this study
Aurora Colorado, 80045, United States
Chicago Illinois, 60637, United States
Bronx New York, 10461, United States
Caba Buenos Aires, 1426, Argentina
Capital Federal Buenos Aires, 1419, Argentina
Ciudad Autonoma Beunos Aires Buenos Aires, 1431, Argentina
Mar Del Plata Buenos Aires, 7600, Argentina
Viedma RIO Negro, 8500, Argentina
Buenos Aires , 1120, Argentina
Cordoba , 5000, Argentina
Sydney New South Wales, 2050, Australia
Woolloongabba Queensland, 4012, Australia
Bowral , 2576, Australia
Linz , 4010, Austria
Salzburger , 5020, Austria
Wels , 4600, Austria
Wien , 1090, Austria
Uberlandia Minas Gerais, 38408, Brazil
Porto Alegre RIO Grande DO SUL, 90035, Brazil
Itajai Santa Catarina, 88301, Brazil
Rio de Janeiro , 22793, Brazil
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3T 1, Canada
Rimouski Quebec, G5L 5, Canada
La Serena Coquimbo, 17204, Chile
Recoleta Metropolitana, 0, Chile
Vina del Mar Valparaiso, 25205, Chile
Angers Cedex 10 , 49933, France
DIJON Cedex , 21079, France
Lille , 59000, France
Marseille Cedex 05 , 13385, France
Paris Cedex 14 , 75679, France
Paris Cedex 18 , 75018, France
Strasbourg , FR-67, France
Villejuif , 94800, France
Herne , 44625, Germany
Jena , 07747, Germany
Koeln , 50968, Germany
Trier , 54292, Germany
Haidari , 12462, Greece
Thessaloniki , 57001, Greece
Tel Aviv Tel-Aviv, 64239, Israel
Jerusalem , 91031, Israel
Ramat-gan , 52621, Israel
Torino TO, 10126, Italy
Milano , 20133, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Reggio Emilia , 42100, Italy
Roma , 00168, Italy
Nagakute-shi Aichi, 48011, Japan
Hirosaki-shi Aomori, 03685, Japan
Sapporo-city Hokkaido, 06085, Japan
Kobe-shi Hyogo, 65000, Japan
Tsukuba-shi Ibaraki, 30585, Japan
Kawasaki-shi Kanagawa, 21685, Japan
Yokohama City Kanagawa, 22200, Japan
Nagasaki-shi Nagasaki, 85285, Japan
Kashihara-shi Nara, 63485, Japan
Niigata-shi Niigata, 95185, Japan
Kurashiki-shi Okayama, 71086, Japan
Hirakata Osaka, 57311, Japan
Osakasayamashi Osaka, 58985, Japan
Takatsuki-shi Osaka, 56986, Japan
Hamamatsu-shi Shizuoka, 43131, Japan
Bunkyo-ku Tokyo, 11386, Japan
Shinjuku-Ku Tokyo, 16085, Japan
Wakayama , 641-8, Japan
Arnhem , 6815 , Netherlands
Rotterdam , 3015 , Netherlands
Moscow , 12130, Russian Federation
Saint-Petersburg , 19903, Russian Federation
Pamplona Navarra, 31008, Spain
Badajoz , 06006, Spain
Badalona-barcelona , 08916, Spain
Madrid , 28041, Spain
Sabadell , 08208, Spain
Santander , 39008, Spain
València , 46010, Spain
Norrkoping , 601 8, Sweden
Umea , 901 8, Sweden
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