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A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
Sponsor: Bristol-Myers Squibb
Summary
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).
Official title: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
855
Start Date
2018-11-06
Completion Date
2027-12-30
Last Updated
2026-02-03
Healthy Volunteers
No
Interventions
Nivolumab
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Cisplatin
Specified dose on specified days
Locations (172)
Local Institution - 0022
Tucson, Arizona, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Local Institution - 0021
Littleton, Colorado, United States
Local Institution - 0036
Pensacola, Florida, United States
Local Institution - 0004
Tampa, Florida, United States
Local Institution - 0144
Atlanta, Georgia, United States
Local Institution - 0005
Chicago, Illinois, United States
Local Institution - 0006
Peoria, Illinois, United States
Local Institution - 0181
Columbia, Maryland, United States
Local Institution - 0009
Boston, Massachusetts, United States
Local Institution - 0166
Boston, Massachusetts, United States
Local Institution - 0209
Boston, Massachusetts, United States
Local Institution - 0025
Minneapolis, Minnesota, United States
Local Institution - 0129
Minneapolis, Minnesota, United States
Local Institution - 0183
Omaha, Nebraska, United States
Local Institution - 0001
Omaha, Nebraska, United States
Local Institution - 0024
Las Vegas, Nevada, United States
Local Institution - 0029
Albany, New York, United States
Local Institution - 0069
Lake Success, New York, United States
Local Institution - 0047
New York, New York, United States
Local Institution - 0191
Cleveland, Ohio, United States
Local Institution - 0028
Tigard, Oregon, United States
Local Institution - 0189
Charleston, South Carolina, United States
Local Institution - 0007
Nashville, Tennessee, United States
Local Institution - 0030
Austin, Texas, United States
Local Institution - 0023
Norfolk, Virginia, United States
Local Institution - 0051
Capital Federal, Buenos Aires, Argentina
Local Institution - 0049
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0151
Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina
Local Institution - 0131
Garran, Australian Capital Territory, Australia
Local Institution - 0130
Kingswood, New South Wales, Australia
Local Institution - 0157
Macquarie University, New South Wales, Australia
Local Institution - 0043
St Leonards, New South Wales, Australia
Local Institution - 0143
North Adelaide, South Australia, Australia
Local Institution - 0037
Heidelberg, Victoria, Australia
Local Institution - 0038
Murdoch, Western Australia, Australia
Local Institution - 0090
Klagenfurt, Austria
Local Institution - 0091
Krems, Austria
Local Institution - 0011
Linz, Austria
Local Institution - 0012
Vienna, Austria
Local Institution - 0060
Brussels, Belgium
Local Institution - 0063
Ghent, Belgium
Local Institution - 0062
Wilrijk, Belgium
Local Institution - 0094
Fortaleza, Ceará, Brazil
Local Institution - 0099
Ipatinga, Minas Gerais, Brazil
Local Institution - 0092
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0212
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0097
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0098
Barretos, São Paulo, Brazil
Local Institution - 0095
Jaú, São Paulo, Brazil
Local Institution - 0093
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0164
Rio de Janeiro, Brazil
Local Institution - 0214
São Paulo, Brazil
Local Institution - 0159
Kelowna, British Columbia, Canada
Local Institution - 0182
North York, Ontario, Canada
Local Institution - 0192
Chicoutimi, Quebec, Canada
Local Institution - 0190
Montreal, Quebec, Canada
Local Institution - 0053
Santiago, Santiago Metropolitan, Chile
Local Institution - 0052
Santiago, Santiago Metropolitan, Chile
Local Institution - 0210
Santiago, Santiago Metropolitan, Chile
Local Institution - 0054
Santiago, Santiago Metropolitan, Chile
Local Institution - 0201
Colombia, Bogota D.C., Colombia
Local Institution - 0104
Bucaramanga, Colombia
Local Institution - 0103
Montería, Colombia
Local Institution - 0148
Helsinki, Finland
Local Institution - 0145
Tampere, Finland
Local Institution - 0146
Turku, Finland
Local Institution - 0202
Brest, Finistère, France
Local Institution - 0204
Créteil, Val-de-Marne, France
Local Institution - 0205
Amiens, France
Local Institution - 0198
Angers, France
Local Institution - 0101
Besançon, France
Local Institution - 0217
Bordeaux, France
Local Institution - 0199
Clermont-Ferrand, France
Local Institution - 0206
La Tronche, France
Local Institution - 0075
Marseille, France
Local Institution - 0200
Montpellier, France
Local Institution - 0074
Nice, France
Local Institution - 0163
Paris, France
Local Institution - 0020
Pierre Benite Cedax, France
Local Institution - 0188
Saint-Herblain, France
Local Institution - 0002
Strasbourg, France
Local Institution - 0003
Toulouse, France
Local Institution - 0100
Mainz, Rhineland-Palatinate, Germany
Local Institution - 0078
Aachen, Germany
Local Institution - 0015
Erfurt, Germany
Local Institution - 0081
Essen, Germany
Local Institution - 0086
Frankfurt am Main, Germany
Local Institution - 0080
Göttingen, Germany
Local Institution - 0013
Herne, Germany
Local Institution - 0010
Jena, Germany
Local Institution - 0084
Lübeck, Germany
Local Institution - 0079
Magdeburg, Germany
Local Institution - 0082
München, Germany
Local Institution - 0016
Nuremberg, Germany
Local Institution - 0085
Trier, Germany
Local Institution - 0195
Athens, Attikí, Greece
Local Institution - 0031
Larissa, Thessalía, Greece
Local Institution - 0194
Chaïdári, Greece
Local Institution - 0196
Tel Aviv, Tel Aviv, Israel
Local Institution - 0068
Beersheba, Israel
Local Institution - 0066
Haifa, Israel
Local Institution - 0067
Ramat Gan, Israel
Local Institution - 0064
Bari, Italy
Local Institution - 0193
Meldola (FC), Italy
Local Institution - 0032
Milan, Italy
Local Institution - 0065
Modena, Italy
Local Institution - 0033
Padova, Italy
Local Institution - 0034
Pisa, Italy
Local Institution - 0035
Roma, Italy
Local Institution - 0186
Komaki, Aichi-ken, Japan
Local Institution - 0184
Sapporo, Hokkaido, Japan
Local Institution - 0177
Sapporo, Hokkaido, Japan
Local Institution - 0185
Sapporo, Hokkaido, Japan
Local Institution - 0179
Tsukuba, Ibaraki, Japan
Local Institution - 0171
Kita-gun, Kagawa-ken, Japan
Local Institution - 0169
Yokohama, Kanagawa, Japan
Local Institution - 0168
Niigata, Niigata, Japan
Local Institution - 0173
Sayama, Osaka, Japan
Local Institution - 0175
Takatsuki, Osaka, Japan
Local Institution - 0176
Hidaka-shi, Saitama, Japan
Local Institution - 0170
Hamamatasu, Shizuoka, Japan
Local Institution - 0178
Minato-ku, Tokyo, Japan
Local Institution - 0172
Shinjuku-ku, Tokyo, Japan
Local Institution - 0174
Fukuoka, Japan
Local Institution - 0180
Kyoto, Japan
Local Institution - 0160
La Paz, BAJA Californa SUR, Mexico
Local Institution - 0102
Zapopan, Jalisco, Mexico
Local Institution - 0056
Monterrey, Nuevo León, Mexico
Local Institution - 0105
Colima, Mexico
Local Institution - 0070
Amsterdam, Netherlands
Local Institution - 0072
Groningen, Netherlands
Local Institution - 0073
Sittard-Geleen, Netherlands
Local Institution - 0087
Auckland, New Zealand
Local Institution - 0089
Christchurch, New Zealand
Local Institution - 0158
Grålum, Norway
Local Institution - 0132
Lorenskog, Norway
Local Institution - 0133
Oslo, Norway
Local Institution - 0153
Lisbon, Portugal
Local Institution - 0152
Porto, Portugal
Local Institution - 0219
Cluj-Napoca, Romania
Local Institution - 0076
Craiova, Romania
Local Institution - 0058
Sector 2, Romania
Local Institution
Saint Petersburg, Russia
Local Institution
Saint Petersburg, Russia
Local Institution - 0154
Singapore, Singapore
Local Institution - 0137
Goyang-si, Gyeonggi-do, South Korea
Local Institution - 0203
Seongnam-si, Kyǒnggi-do, South Korea
Local Institution - 0220
Busan, South Korea
Local Institution - 0218
Daegu, South Korea
Local Institution - 0208
Gyeongsangnam-do, South Korea
Local Institution - 0215
Seongnam-si, South Korea
Local Institution - 0140
Seoul, South Korea
Local Institution - 0136
Seoul, South Korea
Local Institution - 0211
Seoul, South Korea
Local Institution - 0138
Seoul, South Korea
Local Institution - 0113
Lugo, Spain
Local Institution - 0111
Madrid, Spain
Local Institution - 0112
Madrid, Spain
Local Institution - 0114
Madrid, Spain
Local Institution - 0156
Málaga, Spain
Local Institution - 0109
Seville, Spain
Local Institution - 0135
Kaohsiung City, Taiwan
Local Institution - 0165
Taichung, Taiwan
Local Institution - 0141
Taipei, Taiwan
Local Institution - 0139
Taipei, Taiwan
Local Institution - 0128
Chelmsford, Essex, United Kingdom
Local Institution - 0127
York, Yorkshire, United Kingdom
Local Institution - 0122
Glasgow, United Kingdom
Local Institution - 0117
Lancaster, United Kingdom
Local Institution - 0121
London, United Kingdom
Local Institution - 0124
Oxford, United Kingdom