Bladder Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion Criteria:

Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

861

Study ID:

NCT03661320

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 170 Locations for this study

See Locations Near You

Local Institution - 0022
Tucson Arizona, 85711, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Local Institution - 0021
Littleton Colorado, 80120, United States
Local Institution - 0036
Pensacola Florida, 32503, United States
Local Institution - 0004
Tampa Florida, 33612, United States
Local Institution - 0144
Atlanta Georgia, 30342, United States
Local Institution - 0005
Chicago Illinois, 60637, United States
Local Institution - 0006
Peoria Illinois, 61615, United States
Local Institution - 0181
Columbia Maryland, 21044, United States
Local Institution - 0009
Boston Massachusetts, 02114, United States
Local Institution - 0166
Boston Massachusetts, 02215, United States
Local Institution - 0209
Boston Massachusetts, 02215, United States
Local Institution - 0025
Minneapolis Minnesota, 55404, United States
Local Institution - 0129
Minneapolis Minnesota, 55455, United States
Local Institution - 0183
Omaha Nebraska, 68130, United States
Local Institution - 0001
Omaha Nebraska, 68198, United States
Local Institution - 0024
Las Vegas Nevada, 89169, United States
Local Institution - 0029
Albany New York, 12208, United States
Local Institution - 0069
Lake Success New York, 11042, United States
Local Institution - 0047
New York New York, 10065, United States
Local Institution - 0191
Cleveland Ohio, 44195, United States
Local Institution - 0028
Tigard Oregon, 97223, United States
Local Institution - 0189
Charleston South Carolina, 29425, United States
Local Institution - 0007
Nashville Tennessee, 37232, United States
Local Institution - 0030
Austin Texas, 78731, United States
Local Institution - 0023
Norfolk Virginia, 23502, United States
Local Institution - 0051
Capital Federal Buenos Aires, 1426, Argentina
Local Institution - 0049
Ciudad Autónoma de Buenos Aires Buenos Aires, 1280, Argentina
Local Institution - 0151
Ciudad Autonoma Buenos Aires Distrito Federal, 1118, Argentina
Local Institution - 0131
Garran Australian Capital Territory, 2605, Australia
Local Institution - 0130
Kingswood New South Wales, 2747, Australia
Local Institution - 0157
Macquarie University New South Wales, 2109, Australia
Local Institution - 0043
St Leonards New South Wales, 2065, Australia
Local Institution - 0143
North Adelaide South Australia, 5006, Australia
Local Institution - 0037
Heidelberg Victoria, 3084, Australia
Local Institution - 0038
Murdoch Western Australia, 6150, Australia
Local Institution - 0090
Klagenfurt Am Woerthersee , 9020, Austria
Local Institution - 0091
Krems , 3500, Austria
Local Institution - 0011
Linz , 4020, Austria
Local Institution - 0012
Wien , 1090, Austria
Local Institution - 0060
Bruxelles , 1200, Belgium
Local Institution - 0063
Gent , 9000, Belgium
Local Institution - 0062
Wilrijk , 2610, Belgium
Local Institution - 0094
Fortaleza Ceara, 60130, Brazil
Local Institution - 0099
Ipatinga Minas Gerais, 35160, Brazil
Local Institution - 0092
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0212
Porto Alegre RIO Grande DO SUL, 90035, Brazil
Local Institution - 0097
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0098
Barretos Sao Paulo, 14780, Brazil
Local Institution - 0095
Jau Sao Paulo, 17210, Brazil
Local Institution - 0093
Sao Jose Do Rio Preto Sao Paulo, 15090, Brazil
Local Institution - 0164
Rio De Janeiro , 20231, Brazil
Local Institution - 0214
Sao Paulo , 01221, Brazil
Local Institution - 0159
Kelowna British Columbia, V1Y 5, Canada
Local Institution - 0182
North York Ontario, M2K 1, Canada
Local Institution - 0192
Chicoutimi Quebec, G7H 5, Canada
Local Institution - 0190
Montreal Quebec, H3T 1, Canada
Local Institution - 0053
Santiago Metropolitana, 83300, Chile
Local Institution - 0052
Santiago Metropolitana, 83804, Chile
Local Institution - 0210
Santiago Metropolitana, 84203, Chile
Local Institution - 0054
Santiago Metropolitana, , Chile
Local Institution - 0201
Colombia Bogota, 0, Colombia
Local Institution - 0104
Bucaramanga , 68100, Colombia
Local Institution - 0103
Monteria , 23000, Colombia
Local Institution - 0148
Helsinki , 00029, Finland
Local Institution - 0145
Tampere , 33521, Finland
Local Institution - 0146
Turku , 20251, Finland
Local Institution - 0202
Brest Cedex, 29609, France
Local Institution - 0204
Créteil Val-de-Marne, 94010, France
Local Institution - 0205
Amiens , 80054, France
Local Institution - 0198
Angers , 49100, France
Local Institution - 0101
Besancon , 25000, France
Local Institution - 0217
Bordeaux , 33076, France
Local Institution - 0199
Clermont-ferrand , 63000, France
Local Institution - 0206
La Tronche , 38043, France
Local Institution - 0075
Marseille , 13273, France
Local Institution - 0200
Montpellier Cedex 5 , 34298, France
Local Institution - 0074
Nice , 06189, France
Local Institution - 0163
Paris , 75014, France
Local Institution - 0020
Pierre Benite Cedax , 69495, France
Local Institution - 0188
Saint Herblain Cedex , 44805, France
Local Institution - 0002
Strasbourg Cedex , 67091, France
Local Institution - 0003
TOULOUSE Cedex 9 , 31059, France
Local Institution - 0100
Mainz Rheinland-Pfalz, 55131, Germany
Local Institution - 0078
Aachen , 52074, Germany
Local Institution - 0015
Erfurt , 99028, Germany
Local Institution - 0081
Essen , 45136, Germany
Local Institution - 0086
Frankfurt Main , 60590, Germany
Local Institution - 0080
Goettingen , 37075, Germany
Local Institution - 0013
Herne , 44625, Germany
Local Institution - 0010
Jena , 07747, Germany
Local Institution - 0084
Luebeck , 23538, Germany
Local Institution - 0079
Magdeburg , 39120, Germany
Local Institution - 0082
Muenchen , 81675, Germany
Local Institution - 0016
Nuernberg , 90419, Germany
Local Institution - 0085
Trier , 54292, Germany
Local Institution - 0195
Athens Attikí, 155 6, Greece
Local Institution - 0031
Larissa Thessalía, 411 1, Greece
Local Institution - 0194
Chaidari , 12462, Greece
Local Institution - 0196
Tel Aviv Tel-Aviv, 64239, Israel
Local Institution - 0068
Beer Sheva , 84101, Israel
Local Institution - 0066
Haifa , 31096, Israel
Local Institution - 0067
Ramat Gan , 52621, Israel
Local Institution - 0064
Bari , 70124, Italy
Local Institution - 0193
Forlì , 47014, Italy
Local Institution - 0032
Milano , 20133, Italy
Local Institution - 0065
Modena , 41012, Italy
Local Institution - 0033
Padova , 35128, Italy
Local Institution - 0034
Pisa , 56126, Italy
Local Institution - 0035
Roma , 00168, Italy
Local Institution - 0186
Komaki Aichi, 485-8, Japan
Local Institution - 0184
Sapporo Hokkaido, 00308, Japan
Local Institution - 0177
Sapporo Hokkaido, 060-8, Japan
Local Institution - 0185
Sapporo Hokkaido, 06086, Japan
Local Institution - 0179
Tsukuba-shi Ibaraki, 30585, Japan
Local Institution - 0171
Kita-gun Kagawa, 761-0, Japan
Local Institution - 0169
Yokohama Kanagawa, 222-0, Japan
Local Institution - 0168
Niigata-shi Niigata, 95185, Japan
Local Institution - 0173
Osakasayama Osaka, 589-8, Japan
Local Institution - 0175
Takatsuki City Osaka, 56986, Japan
Local Institution - 0176
Hidaka-shi Saitama, 35012, Japan
Local Institution - 0170
Hamamatasu Shizuoka, 431-3, Japan
Local Institution - 0178
Minato-ku Tokyo, 10584, Japan
Local Institution - 0172
Shinjuku-ku Tokyo, 160-8, Japan
Local Institution - 0174
Fukuoka , 812-8, Japan
Local Institution - 0180
Kyoto , 606-8, Japan
Local Institution - 0137
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Local Institution - 0203
Seongnam-si Kyǒnggi-do, 13620, Korea, Republic of
Local Institution - 0220
Busan , 48108, Korea, Republic of
Local Institution - 0218
Daegu , 41404, Korea, Republic of
Local Institution - 0208
Gyeongsangnam-do , 50612, Korea, Republic of
Local Institution - 0215
Seongnam-si, , 13496, Korea, Republic of
Local Institution - 0140
Seoul , 02841, Korea, Republic of
Local Institution - 0136
Seoul , 03080, Korea, Republic of
Local Institution - 0211
Seoul , 05505, Korea, Republic of
Local Institution - 0138
Seoul , 06351, Korea, Republic of
Local Institution - 0160
La Paz BAJA Californa SUR, 23040, Mexico
Local Institution - 0102
Zapopan Jalisco, 45050, Mexico
Local Institution - 0056
Monterrey Nuevo LEON, 64460, Mexico
Local Institution - 0105
Colima , 28017, Mexico
Local Institution - 0070
Amsterdam , 1066 , Netherlands
Local Institution - 0072
Groningen , 9713 , Netherlands
Local Institution - 0073
Sittard-Geleen , 6162 , Netherlands
Local Institution - 0087
Auckland , 1023, New Zealand
Local Institution - 0089
Christchurch , 8011, New Zealand
Local Institution - 0158
Gralum , 1714, Norway
Local Institution - 0132
Lorenskog , 1478, Norway
Local Institution - 0133
Oslo , 0379, Norway
Local Institution - 0153
Lisboa , 1649-, Portugal
Local Institution - 0152
Porto , 4200-, Portugal
Local Institution - 0219
Cluj-Napoca , 40001, Romania
Local Institution - 0076
Craiova , 20054, Romania
Local Institution - 0058
Sector 2 , 02232, Romania
Local Institution
Saint-Petersburg , 19404, Russian Federation
Local Institution
St Petersburg , 19775, Russian Federation
Local Institution - 0154
Singapore , 16858, Singapore
Local Institution - 0113
Lugo , 27003, Spain
Local Institution - 0111
Madrid , 28007, Spain
Local Institution - 0112
Madrid , 28033, Spain
Local Institution - 0114
Madrid , 28041, Spain
Local Institution - 0156
Malaga , 29010, Spain
Local Institution - 0109
Sevilla , 41013, Spain
Local Institution - 0135
Kaohsiung , 83340, Taiwan
Local Institution - 0165
Taichung , 40721, Taiwan
Local Institution - 0141
Taipei City , 10022, Taiwan
Local Institution - 0139
Taipei , 11217, Taiwan
Local Institution - 0128
Chelmsford Essex, CM1 7, United Kingdom
Local Institution - 0127
York Yorkshire, YO31 , United Kingdom
Local Institution - 0122
Glasgow , G12 0, United Kingdom
Local Institution - 0117
Lancaster , LA1 4, United Kingdom
Local Institution - 0121
London , SE1 9, United Kingdom
Local Institution - 0124
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

861

Study ID:

NCT03661320

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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