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:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 190 Locations for this study

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Local Institution
Mobile Alabama, 36608, United States
Local Institution
Chandler Arizona, 85224, United States
Arizona Oncology Associates
Tucson Arizona, 85711, United States More Info
Richard Rosenberg, Site 0022
Contact
520-886-0206
Local Institution
La Jolla California, 92093, United States
Uc Irvine Health
Orange California, 92868, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Local Institution
San Jose California, 95124, United States
Rocky Mountain Cancer Centers Llp
Littleton Colorado, 80120, United States More Info
Manojkumar Bupathi, Site 0021
Contact
303-418-7639
Local Institution
New Haven Connecticut, 06520, United States
Local Institution
Newark Delaware, 19713, United States
Woodlands Medical Specialists, Pa
Pensacola Florida, 32503, United States More Info
Rami Owera, Site 0036
Contact
850-696-0147
Local Institution - 0004
Tampa Florida, 33612, United States
Northside Hospital
Atlanta Georgia, 30342, United States More Info
Crain Garrot, Site 0144
Contact
770-590-8311
University of Chicago Medical Center
Chicago Illinois, 60637, United States More Info
Randy Sweis, Site 0005
Contact
773-702-1152
Illinois Cancer Care
Peoria Illinois, 61615, United States More Info
Madhuri Bajaj, Site 0006
Contact
800-527-6266
Local Institution
Baltimore Maryland, 21201, United States
Maryland Oncology Hematology, P.A.
Columbia Maryland, 21044, United States More Info
Mohit Narang, Site 0181
Contact
410-964-2212
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States More Info
Guru Sonpavde, Site 0166
Contact
205-520-6512
Cancer Center At Milford Regional Medical Center
Boston Massachusetts, 02215, United States More Info
Guru Sonpavde, Site 0209
Contact
205-520-6512
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Guru Sonpavde, Site 0009
Contact
205-520-6512
Minnesota Oncology Hematology
Minneapolis Minnesota, 55404, United States More Info
Samith Kochuparambil, Site 0025
Contact
612-884-6311
Local Institution - 0129
Minneapolis Minnesota, 55455, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States More Info
Ralph Hauke, Site 0183
Contact
402-334-4773
University Of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Benjamin Teply, Site 0001
Contact
617-308-0744
Comprehensive Cancer Centers Of Nevada
Las Vegas Nevada, 89169, United States More Info
Oscar Goodman, Site 0024
Contact
702-952-3400
Local Institution
Camden New Jersey, 08103, United States
New York Oncology Hematology, Pc
Albany New York, 12208, United States More Info
David Shaffer, Site 0029
Contact
518-262-6696
Local Institution - 0069
Lake Success New York, 11042, United States
Columbia University Medical Center (Cumc)
New York New York, 10032, United States More Info
Matthew Dallos, Site 0047
Contact
212-851-4893
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States More Info
Shilpa Gupta, Site 0191
Contact
612-624-5620
Northwest Cancer Specialists, Pc
Tigard Oregon, 97223, United States More Info
Ian Schnadig, Site 0028
Contact
971-708-8700
Medical University Of South Carolina
Charleston South Carolina, 29425, United States More Info
Theodore Gourdin, Site 0189
Contact
803-413-1355
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
Nancy Davis, Site 0007
Contact
615-936-8422
Texas Oncology-Central Austin Cancer Center
Austin Texas, 78731, United States More Info
Jeffrey Yorio, Site 0030
Contact
512-427-9400
Local Institution
Dallas Texas, 75390, United States
Local Institution
Fort Sam Houston Texas, 78234, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States More Info
Mark Fleming, Site 0023
Contact
757-873-9833
Instituto Medico Especializado Alexander Fleming
Capital Federal Buenos Aires, 1426, Argentina More Info
Juan Pablo Sade, Site 0051
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5432218900
Local Institution - 0049
Ciudad Autónoma de Buenos Aires Buenos Aires, 1280, Argentina More Info
Site 0049
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Local Institution - 0151
Ciudad Autonoma Buenos Aires Distrito Federal, 1118, Argentina More Info
Site 0151
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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 More Info
Site 0090
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Local Institution - 0091
Krems , 3500, Austria More Info
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Local Institution - 0011
Linz , 4010, Austria More Info
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Local Institution - 0012
Wien , 1090, Austria More Info
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Local Institution - 0060
Bruxelles , 1200, Belgium More Info
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Local Institution - 0063
Gent , 9000, Belgium More Info
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Local Institution
Leuven , B-300, Belgium
Local Institution - 0062
Wilrijk , 2610, Belgium More Info
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Local Institution - 0094
Fortaleza Ceara, 60130, Brazil More Info
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Local Institution - 0099
Ipatinga Minas Gerais, 35160, Brazil More Info
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Local Institution - 0092
Ijui RIO Grande DO SUL, 98700, Brazil More Info
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Local Institution - 0212
Porto Alegre RIO Grande DO SUL, 90035, Brazil More Info
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Local Institution - 0097
Porto Alegre RIO Grande DO SUL, 90610, Brazil More Info
Site 0097
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Local Institution - 0098
Barretos Sao Paulo, 14780, Brazil More Info
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Local Institution - 0095
Jau Sao Paulo, 17210, Brazil More Info
Site 0095
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Local Institution - 0093
Sao Jose Do Rio Preto Sao Paulo, 15090, Brazil More Info
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Local Institution - 0164
Rio De Janeiro , 20231, Brazil More Info
Site 0164
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Local Institution - 0214
Sao Paulo , 01221, Brazil More Info
Site 0214
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Local Institution
Sao Paulo , 01246, Brazil
Local Institution
Abbotsford British Columbia, V2S 0, Canada
Local Institution - 0159
Kelowna British Columbia, V1Y 5, Canada More Info
Site 0159
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Local Institution - 0182
North York Ontario, M2K 1, Canada More Info
Site 0182
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Local Institution - 0192
Chicoutimi Quebec, G7H 5, Canada More Info
Site 0192
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Local Institution - 0190
Montreal Quebec, H3T 1, Canada More Info
Site 0190
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Local Institution - 0053
Santiago Metropolitana, 83300, Chile More Info
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Local Institution - 0052
Santiago Metropolitana, 83804, Chile More Info
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Local Institution - 0210
Santiago Metropolitana, 84203, Chile More Info
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Local Institution - 0054
Santiago Metropolitana, , Chile More Info
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Local Institution - 0201
Colombia Bogota, 0, Colombia More Info
Site 0201
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Local Institution - 0104
Bucaramanga , 68100, Colombia More Info
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Local Institution - 0103
Monteria , 23000, Colombia More Info
Site 0103
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Local Institution
?lborg , 9000, Denmark
Local Institution
Arhus , 8000, Denmark
Local Institution
Herlev , 2730, Denmark
Local Institution - 0148
Helsinki , 00029, Finland More Info
Site 0148
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Local Institution - 0145
Tampere , 33521, Finland More Info
Site 0145
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Local Institution - 0146
Turku , 20251, Finland More Info
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Local Institution - 0202
Brest Cedex, 29609, France More Info
Site 0202
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Local Institution - 0204
Créteil Val-de-Marne, 94010, France More Info
Site 0204
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Local Institution - 0205
Amiens , 80054, France More Info
Site 0205
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Local Institution - 0198
Angers , 49100, France More Info
Site 0198
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Local Institution - 0101
Besancon Cedex , 25030, France More Info
Site 0101
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Local Institution
Bordeaux , 33075, France
Local Institution - 0217
Bordeaux , 33076, France More Info
Site 0217
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Local Institution - 0199
Clermont-ferrand , 63000, France More Info
Site 0199
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Local Institution - 0206
La Tronche , 38043, France More Info
Site 0206
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Local Institution - 0075
Marseille , 13273, France More Info
Site 0075
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Local Institution - 0200
Montpellier Cedex 5 , 34298, France More Info
Site 0200
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Local Institution - 0074
Nice , 06189, France More Info
Site 0074
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Local Institution - 0163
Paris , 75014, France More Info
Site 0163
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Local Institution - 0020
Pierre Benite Cedax , 69495, France More Info
Site 0020
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Local Institution
Rennes Cedex , 35042, France
Local Institution - 0188
Saint Herblain Cedex , 44805, France More Info
Site 0188
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Local Institution - 0002
Strasbourg Cedex , 67091, France More Info
Site 0002
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Local Institution - 0003
TOULOUSE Cedex 9 , 31059, France More Info
Site 0003
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Local Institution - 0078
Aachen , 52074, Germany More Info
Site 0078
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Local Institution - 0015
Erfurt , 99028, Germany More Info
Site 0015
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Local Institution - 0081
Essen , 45136, Germany More Info
Site 0081
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Local Institution - 0086
Frankfurt Main , 60590, Germany More Info
Site 0086
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Local Institution - 0080
Goettingen , 37075, Germany More Info
Site 0080
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Local Institution
Heidelberg , 69120, Germany
Local Institution - 0013
Herne , 44625, Germany More Info
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Local Institution - 0010
Jena , 07747, Germany More Info
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Local Institution - 0084
Luebeck , 23538, Germany More Info
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Local Institution - 0079
Magdeburg , 39120, Germany More Info
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Local Institution - 0100
Mainz , 55101, Germany More Info
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Local Institution - 0082
Muenchen , 81675, Germany More Info
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Local Institution - 0016
Nuernberg , 90419, Germany More Info
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Local Institution - 0085
Trier , 54292, Germany More Info
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Local Institution - 0031
Larissa Thessalía, 411 1, Greece More Info
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Local Institution
Athens , 11528, Greece
Local Institution - 0194
Chaidari , 12462, Greece More Info
Site 0194
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Local Institution - 0195
Holargos , 15562, Greece More Info
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Local Institution - 0196
Tel Aviv Tel-Aviv, 64239, Israel More Info
Site 0196
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Local Institution - 0068
Beer Sheva , 84101, Israel More Info
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Local Institution - 0066
Haifa , 31096, Israel More Info
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Local Institution - 0067
Ramat Gan , 52621, Israel More Info
Site 0067
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Local Institution - 0064
Bari , 70124, Italy More Info
Site 0064
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Local Institution - 0193
Forlì , 47014, Italy More Info
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Local Institution - 0032
Milano , 20133, Italy More Info
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Local Institution - 0065
Modena , 41012, Italy More Info
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Local Institution - 0033
Padova , 35128, Italy More Info
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Local Institution - 0034
Pisa , 56126, Italy More Info
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Local Institution - 0035
Roma , 00168, Italy More Info
Site 0035
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Local Institution - 0186
Komaki Aichi, 485-8, Japan More Info
Site 0186
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Local Institution - 0184
Sapporo Hokkaido, 00308, Japan More Info
Site 0184
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Local Institution - 0177
Sapporo Hokkaido, 060-8, Japan More Info
Site 0177
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Local Institution - 0185
Sapporo Hokkaido, 06086, Japan More Info
Site 0185
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Local Institution - 0179
Tsukuba-shi Ibaraki, 30585, Japan More Info
Site 0179
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Local Institution - 0171
Kita-gun Kagawa, 761-0, Japan More Info
Site 0171
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Local Institution - 0169
Yokohama Kanagawa, 222-0, Japan More Info
Site 0169
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Local Institution - 0168
Niigata-shi Niigata, 95185, Japan More Info
Site 0168
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Local Institution - 0173
Osakasayama Osaka, 589-8, Japan More Info
Site 0173
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Local Institution - 0175
Takatsuki City Osaka, 56986, Japan More Info
Site 0175
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Local Institution - 0176
Hidaka-shi Saitama, 35012, Japan More Info
Site 0176
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Local Institution - 0170
Hamamatsu-shi Shizuoka, 43131, Japan More Info
Site 0170
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Local Institution - 0178
Minato-ku Tokyo, 10584, Japan More Info
Site 0178
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Local Institution - 0172
Shinjuku-ku Tokyo, 160-8, Japan More Info
Site 0172
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Local Institution - 0174
Fukuoka , 812-8, Japan More Info
Site 0174
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Local Institution - 0180
Kyoto , 606-8, Japan More Info
Site 0180
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Local Institution - 0137
Goyang-si Gyeonggi-do, 10408, Korea, Republic of More Info
Site 0137
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Local Institution - 0203
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of More Info
Site 0203
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Local Institution - 0220
Busan , 48108, Korea, Republic of More Info
Site 0220
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Local Institution - 0218
Daegu , 41404, Korea, Republic of More Info
Site 0218
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Local Institution - 0208
Gyeongsangnam-do , 50612, Korea, Republic of More Info
Site 0208
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Local Institution - 0215
Seongnam-si, , 13496, Korea, Republic of More Info
Site 0215
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Local Institution - 0140
Seoul , 02841, Korea, Republic of More Info
Site 0140
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Local Institution - 0136
Seoul , 03080, Korea, Republic of More Info
Site 0136
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Local Institution - 0211
Seoul , 05505, Korea, Republic of More Info
Site 0211
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Local Institution - 0138
Seoul , 06351, Korea, Republic of More Info
Site 0138
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Local Institution - 0160
La Paz BAJA Californa SUR, 23040, Mexico More Info
Site 0160
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Df Distrito Federal, 06720, Mexico More Info
Site 0161
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Local Institution - 0102
Zapopan Jalisco, 45050, Mexico
Local Institution - 0056
Monterrey Nuevo LEON, 64460, Mexico More Info
Site 0056
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Local Institution - 0105
Colima , 28017, Mexico More Info
Site 0105
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Local Institution - 0070
Amsterdam , 1066 , Netherlands More Info
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Local Institution - 0072
Groningen , 9713 , Netherlands More Info
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Local Institution - 0073
Sittard-Geleen , 6162 , Netherlands More Info
Site 0073
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Local Institution - 0087
Auckland , 1023, New Zealand
Local Institution - 0089
Christchurch , 8011, New Zealand
Local Institution - 0158
Gralum , 1714, Norway More Info
Site 0158
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Local Institution - 0132
Lorenskog , 1478, Norway More Info
Site 0132
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Local Institution - 0133
Oslo , 0379, Norway More Info
Site 0133
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Local Institution - 0153
Lisboa , 1649-, Portugal More Info
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Local Institution - 0152
Porto , 4200-, Portugal More Info
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Local Institution - 0219
Cluj-Napoca , 40001, Romania More Info
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Local Institution - 0076
Craiova , 20034, Romania More Info
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Local Institution - 0058
Sector 2 , 02232, Romania More Info
Site 0058
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Local Institution
Saint-Petersburg , 19404, Russian Federation
Local Institution
St Petersburg , 19775, Russian Federation
Local Institution - 0154
Singapore , 16961, Singapore
Local Institution - 0113
Lugo , 27003, Spain More Info
Site 0113
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Local Institution - 0111
Madrid , 28007, Spain More Info
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Local Institution - 0112
Madrid , 28033, Spain More Info
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Local Institution - 0114
Madrid , 28041, Spain More Info
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Local Institution - 0156
Malaga , 29010, Spain More Info
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Local Institution - 0109
Sevilla , 41013, Spain More Info
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Local Institution - 0135
Kaohsiung , 83340, Taiwan More Info
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Local Institution - 0165
Taichung , 40721, Taiwan More Info
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Local Institution - 0141
Taipei City , 10022, Taiwan More Info
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Local Institution - 0139
Taipei , 11217, Taiwan More Info
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Local Institution - 0128
Chelmsford Essex, CM1 7, United Kingdom More Info
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Local Institution - 0127
York Yorkshire, YO31 , United Kingdom More Info
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Local Institution - 0122
Glasgow , G12 0, United Kingdom More Info
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Local Institution - 0117
Lancaster , LA1 4, United Kingdom More Info
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Local Institution - 0121
London , SE1 9, United Kingdom More Info
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Local Institution - 0124
Oxford , OX3 7, United Kingdom More Info
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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:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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