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
- Conditions
- Various Advanced Cancer
- Interventions
- Biological: NivolumabOther: Placebo
- Registration Number
- NCT02632409
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 709
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nivolumab Nivolumab Nivolumab dose as specified Placebo Placebo Placebo dose as specified
- Primary Outcome Measures
Name Time Method Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population approximately up to 48 months The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Disease Free Survival (DFS) approximately up to 48 months The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Non-Urothelial Tract Recurrence Free Survival up to 53 months The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Overall Survival in Participants With PD-L1 Expression ≥ 1% on going the time from randomization to the date of death from any cause.
Disease Specific Survival in Participants With PD-L1 Expression ≥ 1% on going the time from randomization to the date of death due to disease (urothelial cancer).
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population up to 53 months The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Overall Survival on going the time from randomization to the date of death from any cause.
Disease Specific Survival on going the time from randomization to the date of death due to disease (urothelial cancer).
Trial Locations
- Locations (187)
Local Institution - 0084
🇮🇹Pisa, Italy
Local Institution - 0074
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 0036
🇬🇧London, United Kingdom
Local Institution
🇨🇳Xi'an, Shan3xi, China
Local Institution - 0191
🇨🇳Beijing, Beijing, China
Local Institution - 0005
🇺🇸San Francisco, California, United States
Local Institution - 0069
🇳🇱Amsterdam, Netherlands
Local Institution - 0181
🇷🇴Timisoara, Timis, Romania
Local Institution - 0038
🇨🇱Vina Del Mar, Valparaiso, Chile
Local Institution - 0092
🇨🇴Bogota, Colombia
Local Institution - 0054
🇮🇪Wilton, Cork, Ireland
Local Institution - 0120
🇮🇱Ramat Gan, Israel
Local Institution - 0143
🇯🇵Chiba, Japan
Local Institution - 0089
🇦🇷Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Local Institution - 0112
🇨🇦Sherbrooke, Quebec, Canada
Local Institution - 0132
🇦🇹Vienna, Austria
Local Institution - 0091
🇨🇴Medellin, Colombia
Local Institution - 0144
🇯🇵Hirosaki, Aomori, Japan
Local Institution - 0158
🇨🇳Kaohsiung, Taiwan
Local Institution - 0179
🇺🇸Tucson, Arizona, United States
Local Institution - 0145
🇯🇵Shinjuku-Ku, Tokyo, Japan
Local Institution - 0055
🇵🇱Gdansk, Poland
Local Institution - 0159
🇨🇳Taichung, Taiwan
Local Institution - 0076
🇬🇧Edinburgh, Midlothian, United Kingdom
Local Institution - 0136
🇦🇹Salzburg, Austria
Local Institution - 0109
🇨🇦Montreal, Quebec, Canada
Local Institution - 0052
🇮🇪Dublin, Ireland
Local Institution - 0121
🇮🇱Jerusalem, Israel
Local Institution - 0119
🇮🇱Zerifin, Israel
Local Institution - 0039
🇲🇽Mexico, Distrito Federal, Mexico
Local Institution - 0041
🇳🇱Nijmegen, Netherlands
Local Institution - 0135
🇨🇭Zuerich, Switzerland
Local Institution - 0184
🇦🇺Frankston, Victoria, Australia
Local Institution - 0150
🇯🇵Niigata-shi, Niigata, Japan
Local Institution - 0146
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0048
🇦🇺Liverpool, New South Wales, Australia
Local Institution - 0072
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0183
🇦🇹Wien, Austria
Local Institution - 0099
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0070
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0193
🇨🇳Shanghai, Shanghai, China
Local Institution - 0021
🇦🇷Berazategui, Buenos Aires, Argentina
Local Institution - 0022
🇦🇷Ciudad Autónoma de BuenosAires, Buenos Aires, Argentina
Local Institution - 0020
🇦🇷San Miguel De Tucuman, Tucuman, Argentina
Local Institution - 0094
🇺🇸Fort Wayne, Indiana, United States
Local Institution - 0177
🇺🇸Las Vegas, Nevada, United States
Local Institution - 0180
🇺🇸Tigard, Oregon, United States
Local Institution - 0071
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0168
🇺🇸Maywood, Illinois, United States
Local Institution - 0234
🇺🇸Norfolk, Virginia, United States
Local Institution - 0137
🇨🇱Temuco, Chile
Local Institution - 0007
🇺🇸Mineola, New York, United States
Local Institution - 0101
🇨🇦Montreal, Canada
Local Institution - 0169
🇺🇸Myrtle Beach, South Carolina, United States
Alaska Urological Institute dba Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Local Institution - 0176
🇺🇸Albany, New York, United States
Local Institution - 0167
🇺🇸Gainesville, Florida, United States
Local Institution - 0030
🇺🇸Miami Beach, Florida, United States
Local Institution - 0051
🇺🇸Burnsville, Minnesota, United States
Local Institution - 0090
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0001
🇺🇸New York, New York, United States
Local Institution - 0011
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0073
🇧🇷Cerqueira Cesar, SAO Paulo, Brazil
Local Institution - 0133
🇦🇹Linz, Austria
Local Institution - 0029
🇧🇪Hasselt, Belgium
Local Institution - 0027
🇧🇪Liege, Belgium
Local Institution - 0198
🇨🇳Fuzhou, Fujian, China
Local Institution - 0046
🇦🇺Waratah, New South Wales, Australia
Local Institution - 0175
🇦🇺Perth, Western Australia, Australia
Local Institution - 0227
🇨🇳Nanning, Guangxi, China
Local Institution - 0229
🇨🇳Chengdu, Sichuan, China
Local Institution - 0196
🇨🇳Wuhan, Hubei, China
Local Institution - 0217
🇨🇳Shanghai, Shanghai, China
Local Institution - 0212
🇨🇳Yantai, Shandong, China
Local Institution - 0108
🇩🇰Aalborg, Denmark
Local Institution - 0220
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0124
🇩🇪Heidelberg, Germany
Local Institution - 0093
🇨🇴Floridablanca, Colombia
Local Institution - 0231
🇧🇷Rio De Janeiro, Brazil
Local Institution - 0097
🇫🇷Suresnes, France
Local Institution - 0106
🇩🇰Aarhus N, Denmark
Local Institution - 0115
🇫🇷La Roche-sur-Yon, France
Local Institution - 0080
🇫🇷Marseille Cedex 9, France
Local Institution - 0188
🇩🇪Marburg, Germany
Local Institution - 0125
🇩🇪Essen, Germany
Local Institution - 0107
🇩🇰Copenhagen, Denmark
Local Institution - 0131
🇩🇪Chemnitz, Germany
Local Institution - 0126
🇩🇪Hamburg, Germany
Local Institution - 0128
🇩🇪Muenster, Germany
Local Institution - 0122
🇩🇪Munich, Germany
Local Institution - 0040
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0204
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0102
🇦🇷Viedma, RIO Negro, Argentina
Local Institution - 0047
🇦🇺St. Leonards, New South Wales, Australia
Local Institution - 0009
🇺🇸Chattanooga, Tennessee, United States
Local Institution - 0192
🇨🇳Beijing, Beijing, China
Local Institution - 0233
🇫🇷Clermont-ferrand, France
Local Institution - 0127
🇩🇪Greifswald, Germany
Local Institution - 0123
🇩🇪Jena, Germany
Local Institution - 0081
🇫🇷Paris, France
Local Institution - 0223
🇨🇳Nanchang, Jiangxi, China
Local Institution - 0185
🇩🇪Nuernberg, Germany
Local Institution - 0111
🇬🇷Thessaloniki, Greece
Local Institution - 0155
🇰🇷Seongnam-si, Korea, Republic of
Local Institution - 0130
🇩🇪Regensburg, Germany
Local Institution - 0156
🇰🇷Seoul, Korea, Republic of
Local Institution - 0118
🇮🇱Haifa, Israel
Local Institution - 0189
🇮🇹Reggio Emilia, Italy
Local Institution - 0085
🇮🇹Roma, Italy
Local Institution - 0162
🇯🇵Fukuoka-shi, Fukuoka, Japan
Local Institution - 0163
🇯🇵Nagasaki-shi, Nagasaki, Japan
Local Institution - 0141
🇯🇵Okayama-city, Okayama, Japan
Local Institution - 0032
🇲🇽Monterrey, Nuevo Leon, Mexico
Local Institution - 0058
🇵🇱Wroclaw, Poland
Local Institution - 0161
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 0149
🇯🇵Osakasayama, Osaka, Japan
Local Institution - 0151
🇯🇵Hamamatasu, Shizuoka, Japan
Local Institution - 0138
🇲🇽Df, Distrito Federal, Mexico
Local Institution - 0034
🇲🇽Mexico City, Distrito Federal, Mexico
Local Institution - 0187
🇵🇱Warsaw, Poland
Local Institution - 0186
🇵🇱Wroclaw, Poland
Local Institution - 0160
🇯🇵Sapporo, Hokkaido, Japan
Local Institution - 0116
🇲🇽Mexico, Distrito Federal, Mexico
Local Institution - 0068
🇳🇱Maastrict, Netherlands
Local Institution - 0024
🇬🇧Sutton, Surrey, United Kingdom
Local Institution - 0147
🇯🇵Shinjuku-ku, Tokyo, Japan
Local Institution - 0154
🇰🇷Seoul, Korea, Republic of
Local Institution - 0140
🇷🇺Moscow, Russian Federation
Local Institution - 0153
🇨🇳Taipei, Taiwan
Local Institution - 0148
🇯🇵Tsukuba-shi, Ibaraki, Japan
Local Institution - 0164
🇯🇵Osaka, Japan
Local Institution - 0043
🇵🇪Lima, Peru
Local Institution - 0096
🇷🇴Craiova, Romania
Local Institution - 0031
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0134
🇨🇭Basel, Switzerland
Local Institution - 0025
🇬🇧Manchester, Greater Manchester, United Kingdom
Local Institution - 0064
🇪🇸Madrid, Spain
Local Institution - 0062
🇪🇸Madrid, Spain
Local Institution - 0063
🇪🇸Madrid, Spain
Local Institution - 0105
🇸🇪Lund, Sweden
Local Institution - 0113
🇫🇷Strasbourg, France
Local Institution - 0098
🇫🇷Villejuif, France
Local Institution - 0004
🇺🇸Rochester, Minnesota, United States
Local Institution - 0003
🇺🇸Omaha, Nebraska, United States
Local Institution - 0044
🇺🇸Portland, Oregon, United States
Local Institution - 0010
🇺🇸Portland, Oregon, United States
Local Institution - 0067
🇪🇸Badalona-barcelona, Spain
Local Institution - 0065
🇪🇸Sevilla, Spain
Local Institution - 0152
🇰🇷Seoul, Korea, Republic of
Local Institution - 0157
🇺🇸Buffalo, New York, United States
Local Institution - 0173
🇺🇸Grand Rapids, Michigan, United States
Local Institution - 0203
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0172
🇺🇸Sacramento, California, United States
Local Institution - 0008
🇺🇸Tampa, Florida, United States
Local Institution - 0061
🇺🇸Clovis, California, United States
Local Institution - 0178
🇺🇸Lakewood, Colorado, United States
Local Institution - 0006
🇺🇸New York, New York, United States
Local Institution - 0197
🇮🇹Bergamo, Italy
Local Institution - 0050
🇦🇺Elizabeth Vale, South Australia, Australia
Local Institution - 0100
🇧🇷São Paulo, Brazil
Local Institution - 0206
🇨🇳Beijing, Beijing, China
Local Institution - 0222
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0210
🇨🇳Chongqing, Chongqing, China
Local Institution - 0066
🇪🇸Barcelona, Spain
Local Institution - 0202
🇨🇳Shanghai, Shanghai, China
Local Institution - 0199
🇨🇳Shanghai, Shanghai, China
Local Institution - 0195
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0230
🇨🇳Wenzhou, Zhejiang, China
Local Institution - 0221
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0219
🇨🇳Chengdu, Sichuan, China
Local Institution - 0110
🇬🇷Athens, Greece
Local Institution - 0129
🇩🇪Stuttgart, Germany
Local Institution - 0082
🇮🇹Milano, Italy
Local Institution - 0088
🇮🇹Arezzo, Italy
Local Institution - 0086
🇮🇹Roma, Italy
Local Institution - 0083
🇮🇹Siena, Italy
Local Institution - 0142
🇯🇵Akita-shi, Akita, Japan
Local Institution - 0057
🇵🇱Lodz, Poland
Local Institution - 0035
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0182
🇷🇴Bucuresti, Romania
Local Institution - 0078
🇷🇴Floresti, Romania
Local Institution - 0232
🇪🇸Santander, Spain
Local Institution - 0059
🇬🇧Sheffield, Yorkshire, United Kingdom
Local Institution - 0114
🇬🇧London, United Kingdom
Local Institution - 0171
🇺🇸New Orleans, Louisiana, United States
Local Institution - 0166
🇺🇸Chapel Hill, North Carolina, United States
Local Institution - 0139
🇨🇦Edmonton, Alberta, Canada
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