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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
Sponsor: Bristol-Myers Squibb
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.
Official title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1314
Start Date
2017-03-24
Completion Date
2026-10-20
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
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
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
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 - 0010
Santiago, Santiago Metropolitan, Chile
Local Institution - 0012
Viña del Mar, Valparaiso, 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