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
NCT ID: NCT03036098
Last Updated: 2025-10-24
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1314 participants
INTERVENTIONAL
2017-03-24
2026-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Investigational immunotherapy
Nivolumab
Specified Dose on Specified Days
Ipilimumab
Specified Dose on Specified Days
Arm B: Standard of care chemotherapy
Gemcitabine
Specified Dose on Specified Days
Cisplatin
Specified Dose on Specified Days
Carboplatin
Specified Dose on Specified Days
Arm C: Investigational immunotherapy
Nivolumab
Specified Dose on Specified Days
Gemcitabine
Specified Dose on Specified Days
Cisplatin
Specified Dose on Specified Days
Arm D: Standard of care chemotherapy
Gemcitabine
Specified Dose on Specified Days
Cisplatin
Specified Dose on Specified Days
Interventions
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Nivolumab
Specified Dose on Specified Days
Ipilimumab
Specified Dose on Specified Days
Gemcitabine
Specified Dose on Specified Days
Cisplatin
Specified Dose on Specified Days
Carboplatin
Specified Dose on Specified Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
St 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 - 0009
Buenos Aires, , Argentina
Local Institution - 0134
Córdoba, , Argentina
Local Institution - 0006
Córdoba, , Argentina
Local Institution - 0008
Viedma, , 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
Brasília, Federal District, Brazil
Local Institution - 0021
Ijuí, 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
Florianópolis, Santa Catarina, Brazil
Local Institution - 0018
Barretos, São Paulo, Brazil
Local Institution - 0019
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0053
Halifax, Nova Scotia, Canada
Local Institution - 0064
London, Ontario, Canada
Local Institution - 0054
Québec, Quebec, Canada
Local Institution - 0052
Sherbrooke, Quebec, Canada
Local Institution - 0012
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0010
Santiago, Santiago Metropolitan, Chile
Local Institution - 0106
Vitacura, , Chile
Local Institution - 0171
Beijing, Beijing Municipality, China
Local Institution - 0169
Beijing, Beijing Municipality, China
Local Institution - 0182
Chongqing, Chongqing Municipality, China
Local Institution - 0217
Guiyang, Guizhou, China
Local Institution - 0219
Harbin, Heilongjiang, China
Local Institution - 0180
Wuhan, Hubei, China
Local Institution - 0175
Nanjing, Jiangsu, China
Local Institution - 0177
Nanjing, Jiangsu, China
Local Institution - 0176
Nanjing, 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 Municipality, China
Local Institution - 0162
Shanghai, Shanghai Municipality, China
Local Institution - 0163
Shanghai, Shanghai Municipality, 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 - 0170
Beijing, , China
Local Institution - 0164
Shanghai, , China
Local Institution - 0160
Brno, , Czechia
Local Institution - 0152
Hradec Králové, , Czechia
Local Institution - 0190
Aalborg, , Denmark
Local Institution - 0196
Herlev, , Denmark
Local Institution - 0060
Helsinki, , Finland
Local Institution - 0091
Nîmes, Gard, France
Local Institution - 0089
Lille, , France
Local Institution - 0088
Marseille, , France
Local Institution - 0090
Saint-Priest-en-Jarez, , France
Local Institution - 0092
Suresnes, , France
Local Institution - 0093
Tours, , France
Local Institution - 0094
Villejuif, , France
Local Institution - 0036
Dresden, , Germany
Local Institution - 0048
Essen, , Germany
Local Institution - 0047
Freiburg im Breisgau, , Germany
Local Institution - 0049
Hamburg, , Germany
Local Institution - 0037
Hanover, , Germany
Local Institution - 0041
Jena, , Germany
Local Institution - 0213
Mannheim, , Germany
Local Institution - 0038
Nuremberg, , Germany
Local Institution - 0040
Tübingen, , Germany
Local Institution - 0114
Weiden, , Germany
Local Institution - 0039
Würzburg, , 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
Milan, , Italy
Local Institution - 0110
Napoli, , Italy
Local Institution - 0136
Hirosaki, Aomori, Japan
Local Institution - 0135
Chiba, Chiba, Japan
Local Institution - 0147
Matsuyama, Ehime, Japan
Local Institution - 0140
Fukuoka, Fukuoka, Japan
Local Institution - 0146
Sapporo, Hokkaido, Japan
Local Institution - 0150
Tsukuba, Ibaraki, Japan
Local Institution - 0214
Morioka, Iwate, Japan
Local Institution - 0137
Kita-Gun, Kagawa-ken, Japan
Local Institution - 0141
Niigata, Niigata, Japan
Local Institution - 0143
Okayama, Okayama-ken, Japan
Local Institution - 0144
Osaka, Osaka, Japan
Local Institution - 0139
Sayama, 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, Wakayama, Japan
Local Institution - 0200
Ube, Yamaguchi, Japan
Local Institution - 0129
Mexico City, Mexico City, Mexico
Local Institution - 0154
Mexico City, Mexico City, Mexico
Local Institution - 0130
Tlalpan, Mexico City, Mexico
Local Institution - 0131
Monterrey, Nuevo León, Mexico
Local Institution - 0022
Amsterdam, North 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 - 0031
Lima, , Peru
Local Institution - 0030
Lima, , Peru
Local Institution - 0189
Bydgoszcz, , Poland
Local Institution - 0205
Koszalin, , Poland
Local Institution - 0202
Warsaw, , Poland
Local Institution - 0191
Cluj-Napoca, Cluj, Romania
Local Institution - 0187
Craiova, Dolj, Romania
Local Institution
Moscow, , Russia
Local Institution - 0192
Singapore, Central Singapore, Singapore
Local Institution - 0125
Goyang-si, Gyeonggido, South Korea
Local Institution - 0126
Seongnam-si, , South Korea
Local Institution - 0124
Seoul, , South Korea
Local Institution - 0151
Seoul, , South Korea
Local Institution - 0128
Seoul, , South Korea
Local Institution - 0127
Seoul, , South Korea
Local Institution - 0070
A Coruña, , Spain
Local Institution - 0068
Barcelona, , Spain
Local Institution - 0065
Madrid, , Spain
Local Institution - 0066
Madrid, , Spain
Local Institution - 0209
Santander, , Spain
Local Institution - 0067
Seville, , Spain
Local Institution - 0069
Valencia, , Spain
Local Institution - 0075
Jönköping, , Sweden
Local Institution - 0059
Linköping, , Sweden
Local Institution - 0058
Lund, , Sweden
Local Institution - 0061
Baden, Canton of Aargau, Switzerland
Local Institution - 0042
Chur, , Switzerland
Local Institution - 0156
Kaohsiung City, , Taiwan
Local Institution - 0159
Taichung, , Taiwan
Local Institution - 0158
Taipei, , Taiwan
Local Institution - 0155
Taipei, , Taiwan
Local Institution - 0157
Taoyuan District, , Taiwan
Local Institution - 0194
Ankara, , Turkey (Türkiye)
Local Institution - 0204
Istanbul, , Turkey (Türkiye)
Local Institution - 0193
Izmir, , Turkey (Türkiye)
Countries
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References
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Tomita Y, Ye DW, Fujii A, Takeuchi N. Nivolumab plus gemcitabine-cisplatin for previously untreated unresectable or metastatic urothelial carcinoma: an Asian subgroup analysis from the global phase 3 CheckMate 901 trial. Urol Oncol. 2025 Sep 26:S1078-1439(25)00341-2. doi: 10.1016/j.urolonc.2025.08.022. Online ahead of print.
van der Heijden MS, Sonpavde G, Powles T, Necchi A, Burotto M, Schenker M, Sade JP, Bamias A, Beuzeboc P, Bedke J, Oldenburg J, Chatta G, Urun Y, Ye D, He Z, Valderrama BP, Ku JH, Tomita Y, Filian J, Wang L, Purcea D, Patel MY, Nasroulah F, Galsky MD; CheckMate 901 Trial Investigators. Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma. N Engl J Med. 2023 Nov 9;389(19):1778-1789. doi: 10.1056/NEJMoa2309863. Epub 2023 Oct 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2016-003881-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-901
Identifier Type: -
Identifier Source: org_study_id
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