Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer
- Conditions
- Urothelial Cancer
- Interventions
- Registration Number
- NCT03036098
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1322
- Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra
- No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Women and men must agree to follow specific methods of contraception, if applicable
- Disease that is suitable for local therapy administered with curative intent
- Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm D: Standard of care chemotherapy Gemcitabine - Arm C: Investigational immunotherapy Cisplatin - Arm A: Investigational immunotherapy Nivolumab - Arm C: Investigational immunotherapy Nivolumab - Arm A: Investigational immunotherapy Ipilimumab - Arm B: Standard of care chemotherapy Carboplatin - Arm B: Standard of care chemotherapy Gemcitabine - Arm B: Standard of care chemotherapy Cisplatin - Arm C: Investigational immunotherapy Gemcitabine - Arm D: Standard of care chemotherapy Cisplatin -
- Primary Outcome Measures
Name Time Method Overall survival (OS) in cisplatin-ineligible randomized participants Up to 55 months Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) Up to 52 months Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC Up to 64 months Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC Up to 64 months
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants Up to 55 months Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC) Up to 64 months Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants Up to 55 months European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC Up to 64 months Overall survival (OS) in all randomized participants Up to 55 months European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants Up to 55 months Progression-free survival (PFS) by BICR by PD-L1 expression at >=1% by immunohistochemistry (IHC) Up to 64 months Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants Up to 55 months
Trial Locations
- Locations (174)
Local Institution - 0001
🇺🇸Anchorage, Alaska, United States
Local Institution - 0115
🇺🇸Fresno, California, United States
St Joseph Heritage Healthcare
🇺🇸Santa Rosa, California, United States
Local Institution - 0051
🇺🇸Boca Raton, Florida, United States
Local Institution - 0087
🇺🇸Fort Lauderdale, Florida, United States
Local Institution - 0062
🇺🇸Jacksonville, Florida, United States
Local Institution - 0004
🇺🇸Athens, Georgia, United States
Local Institution - 0033
🇺🇸Thomasville, Georgia, United States
Local Institution - 0046
🇺🇸Chicago, Illinois, United States
Local Institution - 0117
🇺🇸New Orleans, Louisiana, United States
Local Institution - 0056
🇺🇸Boston, Massachusetts, United States
Local Institution - 0073
🇺🇸Boston, Massachusetts, United States
Local Institution - 0208
🇺🇸Boston, Massachusetts, United States
Local Institution - 0207
🇺🇸Milford, Massachusetts, United States
Local Institution - 0063
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0002
🇺🇸Burnsville, Minnesota, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Local Institution - 0032
🇺🇸Kansas City, Missouri, United States
Local Institution - 0095
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0057
🇺🇸Manchester, New Hampshire, United States
Local Institution - 0084
🇺🇸Albuquerque, New Mexico, United States
Local Institution - 0083
🇺🇸Buffalo, New York, United States
Local Institution - 0014
🇺🇸Mineola, New York, United States
Local Institution - 0072
🇺🇸New York, New York, United States
Local Institution - 0116
🇺🇸Durham, North Carolina, United States
Local Institution - 0082
🇺🇸Columbus, Ohio, United States
Local Institution - 0104
🇺🇸Portland, Oregon, United States
Local Institution - 0013
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0086
🇺🇸Kirkland, Washington, United States
Local Institution - 0005
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0007
🇦🇷Mar Del Plata, Buenos Aires, Argentina
Local Institution - 0008
🇦🇷Viedma, RIO Negro, Argentina
Local Institution - 0009
🇦🇷Buenos Aires, Argentina
Local Institution - 0134
🇦🇷Cordoba, Argentina
Local Institution - 0006
🇦🇷Cordoba, Argentina
Local Institution - 0096
🇦🇺Waratah, New South Wales, Australia
Local Institution - 0099
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0188
🇦🇺South Brisbane, Queensland, Australia
Local Institution - 0120
🇦🇺Tugun, Queensland, Australia
Local Institution - 0101
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0100
🇦🇺Doubleview, Western Australia, Australia
Local Institution - 0017
🇧🇷Brasilia, Distrito Federal, Brazil
Local Institution - 0021
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0119
🇧🇷Passo Fundo, RIO Grande DO SUL, Brazil
Local Institution - 0020
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0016
🇧🇷Florianopolis, Santa Catarina, Brazil
Local Institution - 0018
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0019
🇧🇷Sao Jose Do Rio Preto, Sao Paulo, Brazil
Local Institution - 0053
🇨🇦Halifax, Nova Scotia, Canada
Local Institution - 0064
🇨🇦London, Ontario, Canada
Local Institution - 0054
🇨🇦Quebec City, Quebec, Canada
Local Institution - 0052
🇨🇦Sherbrooke, Quebec, Canada
Local Institution - 0010
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0012
🇨🇱Vina del Mar, Valparaiso, Chile
Local Institution - 0106
🇨🇱Vitacura, Chile
Local Institution - 0171
🇨🇳Beijing, Beijing, China
Local Institution - 0169
🇨🇳Beijing, Beijing, China
Local Institution - 0182
🇨🇳Chongqing, Chongqing, China
Local Institution - 0217
🇨🇳Guiyang, Guizhou, China
Local Institution - 0219
🇨🇳Harbin, Heilongjiang, China
Local Institution - 0180
🇨🇳Wuhan, Hubei, China
Local Institution - 0177
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0176
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0175
🇨🇳Nanjng, Jiangsu, China
Local Institution - 0186
🇨🇳Changchun, Jilin, China
Local Institution - 0220
🇨🇳Taiyuan, Shan1xi, China
Local Institution - 0216
🇨🇳Yantai, Shandong, China
Local Institution - 0167
🇨🇳Shanghai, Shanghai, China
Local Institution - 0162
🇨🇳Shanghai, Shanghai, China
Local Institution - 0163
🇨🇳Shanghai, Shanghai, China
Local Institution - 0184
🇨🇳Chengdu, Sichuan, China
Local Institution - 0173
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0174
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0172
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0091
🇫🇷Nîmes, Gard, France
Local Institution - 0170
🇨🇳Beijing, China
Local Institution - 0164
🇨🇳Shanghai, China
Local Institution - 0160
🇨🇿Brno, Czechia
Local Institution - 0152
🇨🇿Hradec Kralove, Czechia
Local Institution - 0190
🇩🇰Aalborg, Denmark
Local Institution - 0196
🇩🇰Herlev, Denmark
Local Institution - 0060
🇫🇮Helsinki, Finland
Local Institution - 0089
🇫🇷Lille, France
Local Institution - 0088
🇫🇷Marseille Cedex 9, France
Local Institution - 0090
🇫🇷St Priest En Jarez, France
Local Institution - 0092
🇫🇷Suresnes, France
Local Institution - 0093
🇫🇷Tours Cedex, France
Local Institution - 0094
🇫🇷Villejuif, France
Local Institution - 0036
🇩🇪Dresden, Germany
Local Institution - 0048
🇩🇪Essen, Germany
Local Institution - 0047
🇩🇪Freiburg, Germany
Local Institution - 0049
🇩🇪Hamburg, Germany
Local Institution - 0037
🇩🇪Hannover, Germany
Local Institution - 0041
🇩🇪Jena, Germany
Local Institution - 0213
🇩🇪Mannheim, Germany
Local Institution - 0038
🇩🇪Nuernberg, Germany
Local Institution - 0040
🇩🇪Tuebingen, Germany
Local Institution - 0114
🇩🇪Weiden, Germany
Local Institution - 0039
🇩🇪Wuerzburg, Germany
Local Institution - 0102
🇬🇷Athens, Greece
Local Institution - 0103
🇬🇷Ioannina, Ípeiros, Greece
Local Institution - 0199
🇮🇱Kfar Saba, Israel
Local Institution - 0198
🇮🇱Ramat Gan, Israel
Local Institution - 0108
🇮🇹Arezzo, Italy
Local Institution - 0197
🇮🇹Faenza, Italy
Local Institution - 0111
🇮🇹Forlì, Italy
Local Institution - 0109
🇮🇹Grosseto, Italy
Local Institution - 0107
🇮🇹Milano, Italy
Local Institution - 0110
🇮🇹Napoli, Italy
Local Institution - 0136
🇯🇵Hirosaki, Aomori, Japan
Local Institution - 0135
🇯🇵Chiba-shi, Chiba, Japan
Local Institution - 0147
🇯🇵Matsuyama-shi, Ehime, Japan
Local Institution - 0140
🇯🇵Fukuoka-shi, Fukuoka, Japan
Local Institution - 0146
🇯🇵Sapporo-city, Hokkaido, Japan
Local Institution - 0150
🇯🇵Tsukuba-shi, Ibaraki, Japan
Local Institution - 0214
🇯🇵Morioka-shi, Iwate, Japan
Local Institution - 0137
🇯🇵Kita-Gun, Kagawa, Japan
Local Institution - 0141
🇯🇵Niigata-shi, Niigata, Japan
Local Institution - 0143
🇯🇵Okayama-shi, Okayama, Japan
Local Institution - 0144
🇯🇵Osaka-shi, Osaka, Japan
Local Institution - 0139
🇯🇵Osakasayama, Osaka, Japan
Local Institution - 0145
🇯🇵Takatsuki-shi, Osaka, Japan
Local Institution - 0201
🇯🇵Hamamatasu, Shizuoka, Japan
Local Institution - 0149
🇯🇵Adachi-ku, Tokyo, Japan
Local Institution - 0148
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0142
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0138
🇯🇵Shinjuku-Ku, Tokyo, Japan
Local Institution - 0215
🇯🇵Wakayama-shi, Wakayama, Japan
Local Institution - 0200
🇯🇵Ube City, Yamaguchi, Japan
Local Institution - 0125
🇰🇷Goyang-si, Gyeonggido, Korea, Republic of
Local Institution - 0126
🇰🇷Seongnam-si, Korea, Republic of
Local Institution - 0124
🇰🇷Seoul, Korea, Republic of
Local Institution - 0151
🇰🇷Seoul, Korea, Republic of
Local Institution - 0128
🇰🇷Seoul, Korea, Republic of
Local Institution - 0127
🇰🇷Seoul, Korea, Republic of
Local Institution - 0129
🇲🇽Ciudad de Mexico, Distrito Federal, Mexico
Local Institution - 0154
🇲🇽Mexico City, Distrito Federal, Mexico
Local Institution - 0130
🇲🇽Tlalpan, Distrito Federal, Mexico
Local Institution - 0131
🇲🇽Monterrey, Nuevo Leon, Mexico
Local Institution - 0022
🇳🇱Amsterdam, Noord-Holland, Netherlands
Local Institution - 0055
🇳🇱Enschede, Netherlands
Local Institution - 0024
🇳🇱Groningen, Netherlands
Local Institution - 0026
🇳🇱Leeuwarden, Netherlands
Local Institution - 0074
🇳🇴Bergen, Norway
Local Institution - 0081
🇳🇴Lorenskog, Norway
Local Institution - 0030
🇵🇪Lima, Peru
Local Institution - 0031
🇵🇪Lima, Peru
Local Institution - 0189
🇵🇱Bydgoszcz, Poland
Local Institution - 0205
🇵🇱Koszalin, Poland
Local Institution - 0202
🇵🇱Warszawa, Poland
Local Institution - 0191
🇷🇴Cluj-Napoca, Cluj, Romania
Local Institution - 0187
🇷🇴Craiova, Dolj, Romania
Local Institution
🇷🇺Moscow, Russian Federation
Local Institution - 0192
🇸🇬Singapore, Central Singapore, Singapore
Local Institution - 0070
🇪🇸A Coruna, Spain
Local Institution - 0068
🇪🇸Barcelona, Spain
Local Institution - 0065
🇪🇸Madrid, Spain
Local Institution - 0066
🇪🇸Madrid, Spain
Local Institution - 0209
🇪🇸Santander, Spain
Local Institution - 0067
🇪🇸Sevilla, Spain
Local Institution - 0069
🇪🇸Valencia, Spain
Local Institution - 0075
🇸🇪Jonkoping, Sweden
Local Institution - 0059
🇸🇪Linkoping, Sweden
Local Institution - 0058
🇸🇪Lund, Sweden
Local Institution - 0061
🇨🇭Baden, Aargau, Switzerland
Local Institution - 0042
🇨🇭Chur, Switzerland
Local Institution - 0156
🇨🇳Kaohsiung, Taiwan
Local Institution - 0159
🇨🇳Taichung, Taiwan
Local Institution - 0158
🇨🇳Taipei, Taiwan
Local Institution - 0155
🇨🇳Taipei, Taiwan
Local Institution - 0157
🇨🇳Taoyuan, Taiwan
Local Institution - 0194
🇹🇷Ankara, Turkey
Local Institution - 0204
🇹🇷Istanbul, Turkey
Local Institution - 0193
🇹🇷Izmir, Turkey