Bladder Cancer Clinical Trial

An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

Summary

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

View Eligibility Criteria

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
Must have disease free status as determined by imaging within 4 weeks of dosing
Tumor tissue must be provided for biomarker analysis
Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

Exclusion Criteria:

Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
Subjects with active, known or suspected autoimmune disease
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

709

Study ID:

NCT02632409

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 180 Locations for this study

See Locations Near You

Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage Alaska, 99503, United States
Local Institution - 0179
Tucson Arizona, 85704, United States
Local Institution - 0061
Clovis California, 93611, United States
Local Institution - 0172
Sacramento California, 95817, United States
Local Institution - 0005
San Francisco California, 94115, United States
Local Institution - 0178
Lakewood Colorado, 80228, United States
Local Institution - 0167
Gainesville Florida, 32610, United States
Local Institution - 0030
Miami Beach Florida, 33140, United States
Local Institution - 0008
Tampa Florida, 33612, United States
Local Institution - 0168
Maywood Illinois, 60153, United States
Local Institution - 0094
Fort Wayne Indiana, 46804, United States
Local Institution - 0171
New Orleans Louisiana, 70112, United States
Local Institution - 0173
Grand Rapids Michigan, 49503, United States
Local Institution - 0051
Burnsville Minnesota, 55337, United States
Local Institution - 0004
Rochester Minnesota, 55905, United States
Local Institution - 0003
Omaha Nebraska, 68130, United States
Local Institution - 0177
Las Vegas Nevada, 89148, United States
Local Institution - 0176
Albany New York, 12208, United States
Local Institution - 0157
Buffalo New York, 14263, United States
Local Institution - 0007
Mineola New York, 11501, United States
Local Institution - 0001
New York New York, 10021, United States
Local Institution - 0006
New York New York, 10029, United States
Local Institution - 0166
Chapel Hill North Carolina, 27599, United States
Local Institution
Durham North Carolina, 27708, United States
Local Institution - 0044
Portland Oregon, 97213, United States
Local Institution - 0010
Portland Oregon, 97239, United States
Local Institution - 0180
Tigard Oregon, 97223, United States
Local Institution - 0074
Allentown Pennsylvania, 18103, United States
Local Institution - 0011
Pittsburgh Pennsylvania, 15212, United States
Local Institution - 0040
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 0169
Myrtle Beach South Carolina, 29572, United States
Local Institution - 0009
Chattanooga Tennessee, 37404, United States
Local Institution - 0234
Norfolk Virginia, 23502, United States
Local Institution - 0021
Berazategui Buenos Aires, 1880, Argentina
Local Institution - 0090
Capital Federal Buenos Aires, 1426, Argentina
Local Institution - 0089
Ciudad Autonoma De Buenos Aire Buenos Aires, 1181, Argentina
Local Institution - 0022
Ciudad Autónoma de BuenosAires Buenos Aires, C1280, Argentina
Local Institution - 0102
Viedma RIO Negro, 8500, Argentina
Local Institution - 0020
San Miguel De Tucuman Tucuman, 4000, Argentina
Local Institution - 0048
Liverpool New South Wales, 2170, Australia
Local Institution - 0047
St. Leonards New South Wales, 2065, Australia
Local Institution - 0046
Waratah New South Wales, 2298, Australia
Local Institution - 0050
Elizabeth Vale South Australia, 5112, Australia
Local Institution - 0184
Frankston Victoria, 3199, Australia
Local Institution - 0175
Perth Western Australia, 6150, Australia
Local Institution - 0133
Linz , 4010, Austria
Local Institution - 0136
Salzburg , 5020, Austria
Local Institution - 0132
Vienna , 1090, Austria
Local Institution - 0183
Wien , 1090, Austria
Local Institution - 0029
Hasselt , 3500, Belgium
Local Institution - 0027
Liege , 4000, Belgium
Local Institution - 0071
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0072
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0070
Barretos Sao Paulo, 14780, Brazil
Local Institution - 0073
Cerqueira Cesar SAO Paulo, 01246, Brazil
Local Institution - 0231
Rio De Janeiro , 20231, Brazil
Local Institution - 0100
São Paulo , 04014, Brazil
Local Institution - 0139
Edmonton Alberta, T6G 1, Canada
Local Institution - 0109
Montreal Quebec, H4A 3, Canada
Local Institution - 0112
Sherbrooke Quebec, J1H 5, Canada
Local Institution - 0101
Montreal , H2X 0, Canada
Local Institution - 0099
Santiago Metropolitana, , Chile
Local Institution - 0038
Vina Del Mar Valparaiso, 25403, Chile
Local Institution - 0137
Temuco , 48102, Chile
Local Institution - 0191
Beijing Beijing, 10000, China
Local Institution - 0206
Beijing Beijing, 10003, China
Local Institution - 0192
Beijing Beijing, 10005, China
Local Institution - 0210
Chongqing Chongqing, 40003, China
Local Institution - 0198
Fuzhou Fujian, 35000, China
Local Institution - 0222
Guangzhou Guangdong, 51023, China
Local Institution - 0203
Guangzhou Guangdong, 51028, China
Local Institution - 0227
Nanning Guangxi, 53002, China
Local Institution - 0196
Wuhan Hubei, 43003, China
Local Institution - 0220
Nanjing Jiangsu, 21000, China
Local Institution - 0204
Nanjing Jiangsu, 21002, China
Local Institution - 0223
Nanchang Jiangxi, 33000, China
Local Institution
Xi'an Shan3xi, 71006, China
Local Institution - 0212
Yantai Shandong, 26400, China
Local Institution - 0193
Shanghai Shanghai, 20003, China
Local Institution - 0202
Shanghai Shanghai, 20003, China
Local Institution - 0199
Shanghai Shanghai, 20004, China
Local Institution - 0217
Shanghai Shanghai, 20004, China
Local Institution - 0229
Chengdu Sichuan, 61004, China
Local Institution - 0219
Chengdu Sichuan, 61007, China
Local Institution - 0221
Hangzhou Zhejiang, 31000, China
Local Institution - 0195
Hangzhou Zhejiang, 31001, China
Local Institution - 0230
Wenzhou Zhejiang, 32500, China
Local Institution - 0092
Bogota , 0, Colombia
Local Institution - 0093
Floridablanca , 68100, Colombia
Local Institution - 0091
Medellin , 05003, Colombia
Local Institution - 0108
Aalborg , 9100, Denmark
Local Institution - 0106
Aarhus N , 8200, Denmark
Local Institution - 0107
Copenhagen , 2100, Denmark
Local Institution - 0233
Clermont-ferrand , 63000, France
Local Institution - 0115
La Roche-sur-Yon , 85000, France
Local Institution - 0080
Marseille Cedex 9 , 13273, France
Local Institution - 0081
Paris , 75475, France
Local Institution - 0113
Strasbourg , 67200, France
Local Institution - 0097
Suresnes , 92151, France
Local Institution - 0098
Villejuif , 94800, France
Local Institution - 0131
Chemnitz , 09130, Germany
Local Institution - 0125
Essen , 45136, Germany
Local Institution - 0127
Greifswald , 17475, Germany
Local Institution - 0126
Hamburg , 20246, Germany
Local Institution - 0124
Heidelberg , 69126, Germany
Local Institution - 0123
Jena , 07747, Germany
Local Institution - 0188
Marburg , 35043, Germany
Local Institution - 0128
Muenster , 48149, Germany
Local Institution - 0122
Munich , 81675, Germany
Local Institution - 0185
Nuernberg , 90419, Germany
Local Institution - 0130
Regensburg , 93053, Germany
Local Institution - 0129
Stuttgart , 70174, Germany
Local Institution - 0110
Athens , 11528, Greece
Local Institution - 0111
Thessaloniki , 54007, Greece
Local Institution - 0054
Wilton Cork, 0, Ireland
Local Institution - 0052
Dublin , , Ireland
Local Institution - 0118
Haifa , 31096, Israel
Local Institution - 0121
Jerusalem , 91120, Israel
Local Institution - 0120
Ramat Gan , 52621, Israel
Local Institution - 0119
Zerifin , 70300, Israel
Local Institution - 0088
Arezzo , 52100, Italy
Local Institution - 0197
Bergamo , 24127, Italy
Local Institution - 0082
Milano , 20133, Italy
Local Institution - 0084
Pisa , 56126, Italy
Local Institution - 0189
Reggio Emilia , 42100, Italy
Local Institution - 0085
Roma , 00144, Italy
Local Institution - 0086
Roma , 00152, Italy
Local Institution - 0083
Siena , 53100, Italy
Local Institution - 0142
Akita-shi Akita, 01085, Japan
Local Institution - 0144
Hirosaki Aomori, 03685, Japan
Local Institution - 0162
Fukuoka-shi Fukuoka, 81285, Japan
Local Institution - 0161
Sapporo-shi Hokkaido, 06086, Japan
Local Institution - 0160
Sapporo Hokkaido, 060-8, Japan
Local Institution - 0148
Tsukuba-shi Ibaraki, 30585, Japan
Local Institution - 0163
Nagasaki-shi Nagasaki, 85285, Japan
Local Institution - 0150
Niigata-shi Niigata, 95185, Japan
Local Institution - 0141
Okayama-city Okayama, 700-8, Japan
Local Institution - 0149
Osakasayama Osaka, 589-8, Japan
Local Institution - 0151
Hamamatasu Shizuoka, 431-3, Japan
Local Institution - 0146
Bunkyo-ku Tokyo, 11386, Japan
Local Institution - 0145
Shinjuku-Ku Tokyo, 16085, Japan
Local Institution - 0147
Shinjuku-ku Tokyo, 16286, Japan
Local Institution - 0143
Chiba , 260-8, Japan
Local Institution - 0164
Osaka , 54185, Japan
Local Institution - 0155
Seongnam-si , 13620, Korea, Republic of
Local Institution - 0154
Seoul , 03722, Korea, Republic of
Local Institution - 0152
Seoul , 05505, Korea, Republic of
Local Institution - 0156
Seoul , 06351, Korea, Republic of
Local Institution - 0138
Df Distrito Federal, 06720, Mexico
Local Institution - 0034
Mexico City Distrito Federal, 14080, Mexico
Local Institution - 0116
Mexico Distrito Federal, 06700, Mexico
Local Institution - 0039
Mexico Distrito Federal, 14080, Mexico
Local Institution - 0035
Guadalajara Jalisco, 44270, Mexico
Local Institution - 0032
Monterrey Nuevo Leon, 64460, Mexico
Local Institution - 0069
Amsterdam , 1105 , Netherlands
Local Institution - 0068
Maastrict , 6229 , Netherlands
Local Institution - 0041
Nijmegen , 6500 , Netherlands
Local Institution - 0043
Lima , Lima , Peru
Local Institution - 0055
Gdansk , 80-21, Poland
Local Institution - 0057
Lodz , 93-51, Poland
Local Institution - 0187
Warsaw , 02-79, Poland
Local Institution - 0058
Wroclaw , 50-55, Poland
Local Institution - 0186
Wroclaw , 53-41, Poland
Local Institution - 0182
Bucuresti , 02138, Romania
Local Institution - 0096
Craiova , 20034, Romania
Local Institution - 0078
Floresti , 40728, Romania
Local Institution - 0181
Timisoara, Timis , 30023, Romania
Local Institution - 0140
Moscow , 12528, Russian Federation
Local Institution - 0031
Saint-Petersburg , 19775, Russian Federation
Local Institution - 0067
Badalona-barcelona , 08916, Spain
Local Institution - 0066
Barcelona , 08035, Spain
Local Institution - 0064
Madrid , 28007, Spain
Local Institution - 0062
Madrid , 28034, Spain
Local Institution - 0063
Madrid , 28041, Spain
Local Institution - 0232
Santander , 39008, Spain
Local Institution - 0065
Sevilla , 41013, Spain
Local Institution - 0105
Lund , 221 8, Sweden
Local Institution - 0134
Basel , 4031, Switzerland
Local Institution - 0135
Zuerich , 8038, Switzerland
Local Institution - 0158
Kaohsiung , 807, Taiwan
Local Institution - 0159
Taichung , 404, Taiwan
Local Institution - 0153
Taipei , 100, Taiwan
Local Institution - 0025
Manchester Greater Manchester, M20 4, United Kingdom
Local Institution - 0076
Edinburgh Midlothian, EH4 2, United Kingdom
Local Institution - 0024
Sutton Surrey, SM2 5, United Kingdom
Local Institution - 0059
Sheffield Yorkshire, S10 2, United Kingdom
Local Institution - 0036
London , SE1 9, United Kingdom
Local Institution - 0114
London , SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

709

Study ID:

NCT02632409

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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