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.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

13

Study ID:

NCT04149574

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 81 Locations for this study

See Locations Near You

The University Of Chicago
Chicago Illinois, 60637, United States
Local Institution - 0084
Bronx New York, 10461, United States
Local Institution - 0009
Caba Buenos Aires, 1426, Argentina
Local Institution - 0088
Capital Federal Buenos Aires, 1419, Argentina
Local Institution - 0016
Ciudad Autonoma Beunos Aires Buenos Aires, 1431, Argentina
Local Institution - 0081
Mar Del Plata Buenos Aires, 7600, Argentina
Local Institution - 0008
Viedma RIO Negro, 8500, Argentina
Local Institution - 0080
Buenos Aires , 1120, Argentina
Local Institution - 0107
Cordoba , 5000, Argentina
Local Institution - 0002
Sydney New South Wales, 2050, Australia
Local Institution - 0001
Woolloongabba Queensland, 4012, Australia
Local Institution - 0114
Bowral , 2576, Australia
Local Institution - 0097
Linz , 4010, Austria
Local Institution - 0104
Salzburger , 5020, Austria
Local Institution - 0098
Wels , 4600, Austria
Local Institution - 0099
Wien , 1090, Austria
Local Institution - 0050
Uberlandia Minas Gerais, 38408, Brazil
Local Institution - 0048
Porto Alegre RIO Grande DO SUL, 90035, Brazil
Local Institution - 0047
Itajai Santa Catarina, 88301, Brazil
Local Institution - 0049
Rio de Janeiro , 22793, Brazil
Local Institution - 0017
Toronto Ontario, M5G 1, Canada
Local Institution - 0038
Montreal Quebec, H2X 0, Canada
Local Institution - 0037
Montreal Quebec, H3T 1, Canada
Local Institution - 0012
Rimouski Quebec, G5L 5, Canada
Local Institution - 0011
La Serena Coquimbo, 17204, Chile
Local Institution - 0010
Recoleta Metropolitana, 0, Chile
Local Institution - 0072
Vina del Mar Valparaiso, 25205, Chile
Local Institution - 0042
Angers Cedex 10 , 49933, France
Local Institution - 0106
DIJON Cedex , 21079, France
Local Institution - 0045
Lille , 59000, France
Local Institution - 0108
Marseille Cedex 05 , 13385, France
Local Institution - 0103
Paris Cedex 14 , 75679, France
Local Institution - 0111
Paris Cedex 18 , 75018, France
Local Institution - 0041
Strasbourg , FR-67, France
Local Institution - 0040
Villejuif , 94800, France
Local Institution - 0094
Herne , 44625, Germany
Local Institution - 0093
Jena , 07747, Germany
Local Institution - 0105
Koeln , 50968, Germany
Local Institution - 0095
Trier , 54292, Germany
Local Institution - 0031
Haidari , 12462, Greece
Local Institution - 0032
Thessaloniki , 57001, Greece
Local Institution - 0075
Tel Aviv Tel-Aviv, 64239, Israel
Local Institution - 0073
Jerusalem , 91031, Israel
Local Institution - 0074
Ramat-gan , 52621, Israel
Local Institution - 0067
Torino TO, 10126, Italy
Local Institution - 0062
Milano , 20133, Italy
Local Institution - 0063
Modena , 41124, Italy
Local Institution - 0064
Napoli , 80131, Italy
Local Institution - 0065
Reggio Emilia , 42100, Italy
Local Institution - 0066
Roma , 00168, Italy
Local Institution - 0147
Nagakute-shi Aichi, 48011, Japan
Local Institution - 0158
Hirosaki-shi Aomori, 03685, Japan
Local Institution - 0161
Sapporo-city Hokkaido, 06085, Japan
Local Institution - 0155
Kobe-shi Hyogo, 65000, Japan
Local Institution - 0149
Tsukuba-shi Ibaraki, 30585, Japan
Local Institution - 0146
Kawasaki-shi Kanagawa, 21685, Japan
Local Institution - 0153
Yokohama City Kanagawa, 22200, Japan
Local Institution - 0164
Nagasaki-shi Nagasaki, 85285, Japan
Local Institution - 0151
Kashihara-shi Nara, 63485, Japan
Local Institution - 0165
Niigata-shi Niigata, 95185, Japan
Local Institution - 0156
Kurashiki-shi Okayama, 71086, Japan
Local Institution - 0157
Hirakata Osaka, 57311, Japan
Local Institution - 0154
Osakasayamashi Osaka, 58985, Japan
Local Institution - 0160
Takatsuki-shi Osaka, 56986, Japan
Local Institution - 0159
Hamamatsu-shi Shizuoka, 43131, Japan
Local Institution - 0162
Bunkyo-ku Tokyo, 11386, Japan
Local Institution - 0150
Shinjuku-Ku Tokyo, 16085, Japan
Local Institution - 0145
Wakayama , 641-8, Japan
Local Institution - 0054
Arnhem , 6815 , Netherlands
Local Institution
Rotterdam , 3015 , Netherlands
Local Institution - 0051
Moscow , 12130, Russian Federation
Local Institution - 0052
Saint-Petersburg , 19903, Russian Federation
Local Institution - 0096
Pamplona Navarra, 31008, Spain
Local Institution - 0061
Badajoz , 06006, Spain
Local Institution - 0060
Badalona-barcelona , 08916, Spain
Local Institution - 0055
Madrid , 28041, Spain
Local Institution - 0059
Sabadell , 08208, Spain
Local Institution - 0057
Santander , 39008, Spain
Local Institution - 0058
València , 46010, Spain
Local Institution - 0087
Norrkoping , 601 8, Sweden
Local Institution - 0083
Umea , 901 8, Sweden

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

13

Study ID:

NCT04149574

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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