A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
NCT ID: NCT04100018
Last Updated: 2025-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1030 participants
INTERVENTIONAL
2020-02-06
2024-06-25
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
QUADRUPLE
Study Groups
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Arm A: Nivolumab + docetaxel + prednisone
Nivolumab
Specified dose on specified days
Prednisone
Specified dose on specified days
Docetaxel
Specified dose on specified days
Arm B: Placebo + docetaxel + prednisone
Prednisone
Specified dose on specified days
Docetaxel
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Prednisone
Specified dose on specified days
Docetaxel
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
* Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
* Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
* Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
* Men must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
* Active, known, or suspected autoimmune disease
* Condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel
18 Years
MALE
No
Sponsors
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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 - 0305
Mobile, Alabama, United States
Local Institution - 0012
Anchorage, Alaska, United States
Local Institution - 0293
Tucson, Arizona, United States
Local Institution - 0269
Jonesboro, Arkansas, United States
Local Institution - 0179
Orange, California, United States
Local Institution - 0055
Rancho Mirage, California, United States
Local Institution - 0260
Redondo Beach, California, United States
Local Institution - 0081
Santa Monica, California, United States
Local Institution - 0087
Denver, Colorado, United States
Local Institution - 0190
West Haven, Connecticut, United States
Local Institution - 0366
Washington D.C., District of Columbia, United States
Local Institution - 0196
Hollywood, Florida, United States
Local Institution - 0397
Jacksonville, Florida, United States
Local Institution - 0164
Lakeland, Florida, United States
Local Institution - 0181
Orlando, Florida, United States
Local Institution - 0285
Pensacola, Florida, United States
Local Institution - 0177
Weston, Florida, United States
Local Institution - 0117
Atlanta, Georgia, United States
Local Institution - 0126
Marietta, Georgia, United States
Local Institution - 0382
Thomasville, Georgia, United States
Local Institution - 0287
Niles, Illinois, United States
Local Institution - 0183
Fort Wayne, Indiana, United States
Local Institution - 0302
Louisville, Kentucky, United States
Local Institution - 0150
Baltimore, Maryland, United States
Local Institution - 0332
Brandywine, Maryland, United States
Local Institution - 0299
Omaha, Nebraska, United States
Local Institution - 0365
East Brunswick, New Jersey, United States
Local Institution - 0139
Florham Park, New Jersey, United States
Local Institution - 0300
Albany, New York, United States
Local Institution - 0028
Port Jefferson Station, New York, United States
Local Institution - 0333
Columbus, Ohio, United States
Local Institution - 0180
Allentown, Pennsylvania, United States
Local Institution - 0074
Bala-Cynwyd, Pennsylvania, United States
Local Institution - 0292
Pittsburgh, Pennsylvania, United States
Local Institution - 0233
Charleston, South Carolina, United States
Local Institution - 0115
Myrtle Beach, South Carolina, United States
Local Institution - 0149
Germantown, Tennessee, United States
Local Institution - 0286
Austin, Texas, United States
Local Institution - 0303
Dallas, Texas, United States
Local Institution - 0284
Houston, Texas, United States
Local Institution - 0195
Houston, Texas, United States
Local Institution - 0011
San Antonio, Texas, United States
The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center
Tyler, Texas, United States
Local Institution - 0110
Seattle, Washington, United States
Local Institution - 0289
Spokane, Washington, United States
Local Institution - 0129
Mar del Plata, Buenos Aires, Argentina
Local Institution - 0061
Pergamino, Buenos Aires, Argentina
Local Institution - 0153
Parana, Córdoba Province, Argentina
Local Institution - 0393
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0083
Viedma, Río Negro Province, Argentina
Local Institution - 0077
Buenos Aires, , Argentina
Local Institution - 0178
Buenos Aires, , Argentina
Local Institution - 0185
Buenos Aires, , Argentina
Local Institution - 0369
La Rioja, , Argentina
Local Institution - 0394
San Juan, , Argentina
Local Institution - 0152
Gosford, New South Wales, Australia
Local Institution - 0091
Lismore, New South Wales, Australia
Local Institution - 0132
Wahroonga, New South Wales, Australia
Local Institution - 0127
Westmead, New South Wales, Australia
Local Institution - 0006
South Brisbane, Queensland, Australia
Local Institution - 0084
Woolloongabba, Queensland, Australia
Local Institution - 0010
North Adelaide, South Australia, Australia
Local Institution - 0379
Ballarat, Victoria, Australia
Local Institution - 0040
Frankston, Victoria, Australia
Local Institution - 0032
Malvern, Victoria, Australia
Local Institution - 0118
Linz, Upper Austria, Austria
Local Institution - 0038
Salzburg, , Austria
Local Institution - 0157
Vienna, , Austria
Local Institution - 0131
Vienna, , Austria
Local Institution - 0122
Anderlecht, Brussels Capital, Belgium
Local Institution - 0121
Bruges, , Belgium
Local Institution - 0114
Ghent, , Belgium
Local Institution - 0162
Ghent, , Belgium
Local Institution - 0137
Turnhout, , Belgium
Local Institution - 0029
Wilrijk, , Belgium
Local Institution - 0097
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0022
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0100
Curitiba, Paraná, Brazil
Local Institution - 0082
Curitiba, Paraná, Brazil
Local Institution - 0321
Natal, Rio Grande do Norte, Brazil
Local Institution - 0058
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0063
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0056
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0057
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0086
Campinas, São Paulo, Brazil
Local Institution - 0059
Santo André, São Paulo, Brazil
Local Institution - 0096
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0189
Rio de Janeiro, , Brazil
Local Institution - 0060
Rio de Janeiro, , Brazil
Local Institution - 0080
São Paulo, , Brazil
Local Institution - 0273
São Paulo, , Brazil
Local Institution - 0328
São Paulo, , Brazil
Local Institution - 0151
Brampton, Ontario, Canada
Local Institution - 0191
Toronto, Ontario, Canada
Local Institution - 0143
Montreal, Quebec, Canada
Local Institution - 0027
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0026
Santiago, RM, Chile
Local Institution - 0378
Providencia, Santiago Metropolitan, Chile
Local Institution - 0025
Santiago, Santiago Metropolitan, Chile
Local Institution - 0377
Santiago, Santiago Metropolitan, Chile
Local Institution - 0245
Beijing, Beijing Municipality, China
Local Institution - 0140
Beijing, Beijing Municipality, China
Local Institution - 0254
Beijing, Beijing Municipality, China
Local Institution - 0337
Beijing, Beijing Municipality, China
Local Institution - 0345
Beijing, Beijing Municipality, China
Local Institution - 0312
Beijing, Bei, China
Local Institution - 0256
Fuzhou, Fujian, China
Local Institution - 0319
Guangzhou, Guangdong, China
Local Institution - 0320
Baoding Shi, Hebei, China
Local Institution - 0224
Harbin, Heilongjiang, China
Local Institution - 0314
Henan Sheng, Henan, China
Local Institution - 0275
Zhengzhou, Henan, China
Local Institution - 0313
Wuhan, Hubei, China
Local Institution - 0168
Changsha, Hunan, China
Local Institution - 0165
Nanjing, Jiangsu, China
Local Institution - 0317
Nanjing, Jiangsu, China
Local Institution - 0325
Nanjing, Jiangsu, China
Local Institution - 0347
Nanchang, Jiangxi, China
Local Institution - 0330
Nanchang, Jiangxi, China
Local Institution - 0161
Shenyang, Liaoning, China
Local Institution - 0326
Jinan, Shandong, China
Local Institution - 0155
Shanghai, Shanghai Municipality, China
Local Institution - 0353
Xi'an, Shannxi, China
Local Institution - 0253
Chengdu, Sichuan, China
Local Institution - 0310
Ürümqi, Xinjiang, China
Local Institution - 0316
Hangzhou, Zhejiang, China
Local Institution - 0344
Hangzhou, Zhejiang, China
Local Institution - 0108
Brno, , Czechia
Local Institution - 0093
Brno, , Czechia
Local Institution - 0049
Olomouc, , Czechia
Local Institution - 0088
Ostrava, , Czechia
Local Institution - 0050
Prague, , Czechia
Local Institution - 0361
Prague, , Czechia
Local Institution - 0105
Strasbourg, Alsace, France
Local Institution - 0079
Lille, Nord, France
Local Institution - 0167
Le Mans, Sarthe, France
Local Institution - 0107
Angers, , France
Local Institution - 0202
Brest, , France
Local Institution - 0398
Dijon, , France
Local Institution - 0030
Hyères, , France
Local Institution - 0395
Montpellier, , France
Local Institution - 0109
Montpellier, , France
Local Institution - 0384
Nice, , France
Local Institution - 0068
Nîmes, , France
Local Institution - 0381
Paris, , France
Local Institution - 0106
Paris, , France
Local Institution - 0071
Paris, , France
Local Institution - 0133
Pierre-Bénite, , France
Local Institution - 0399
Reims, , France
Local Institution - 0380
Rennes, , France
Local Institution - 0387
Strasbourg, , France
Local Institution - 0271
Villejuif, , France
Local Institution - 0023
Nürtingen, Baden-Wurttemberg, Germany
Local Institution - 0014
Koblenz, Rheinland Pfa, Germany
Local Institution - 0090
Dresden, Saxony, Germany
Local Institution - 0089
Bonn, , Germany
Local Institution - 0376
Düsseldorf, , Germany
Local Institution - 0172
Emmendingen, , Germany
Local Institution - 0142
Erlangen, , Germany
Local Institution - 0018
Frankfurt am Main, , Germany
Local Institution - 0064
Hamburg, , Germany
Local Institution - 0069
Hamburg, , Germany
Local Institution - 0389
Heidelberg, , Germany
Local Institution - 0004
Magdeburg, , Germany
Local Institution - 0372
Marburg, , Germany
Local Institution - 0204
München, , Germany
Local Institution - 0036
Münster, , Germany
Local Institution - 0169
Tübingen, , Germany
Local Institution - 0145
Hong Kong, , Hong Kong
Local Institution - 0045
Hong Kong, , Hong Kong
Local Institution - 0146
Hong Kong, , Hong Kong
Local Institution - 0072
Haifa, , Israel
Local Institution - 0388
Jerusalem, , Israel
Local Institution - 0368
Kfar Saba, , Israel
Local Institution - 0128
Petah Tikva, , Israel
Local Institution - 0135
Ramat Gan, , Israel
Local Institution - 0138
Tel Aviv, , Israel
Local Institution - 0099
Benevento, , Italy
Local Institution - 0001
Bergamo, , Italy
Local Institution - 0111
Bologna, , Italy
Local Institution - 0039
Brescia, , Italy
Local Institution - 0053
Cremona, , Italy
Local Institution - 0066
Milan, , Italy
Local Institution - 0120
Napoli, , Italy
Local Institution - 0070
Orbassano, , Italy
Local Institution - 0037
Parma, , Italy
Local Institution - 0199
Pisa, , Italy
Local Institution - 0046
Rome, , Italy
Local Institution - 0385
Rome, , Italy
Local Institution - 0067
Trento, , Italy
Local Institution - 0362
Nagoya, Aichi-ken, Japan
Local Institution - 0340
Akita, Akita, Japan
Local Institution - 0358
Hirosaki-shi, Aomori, Japan
Local Institution - 0346
Chiba, Chiba, Japan
Local Institution - 0339
Sakura-Shi, Chiba, Japan
Local Institution - 0307
Matsuyama, Ehime, Japan
Local Institution - 0280
Fukuoka, Fukuoka, Japan
Local Institution - 0281
Sapporo, Hokkaido, Japan
Local Institution - 0296
Sapporo, Hokkaido, Japan
Local Institution - 0283
Yokohama, Kanagawa, Japan
Local Institution - 0324
Kumamoto, Kumamoto, Japan
Local Institution - 0342
Kamigyō-ku, Kyoto, Japan
Local Institution - 0355
Kashihara-shi, Nara, Japan
Local Institution - 0343
Osaka, Osaka, Japan
Local Institution - 0323
Ōsaka-sayama, Osaka, Japan
Local Institution - 0309
Hamamatsu, Shizuoka, Japan
Local Institution - 0279
Toyama, Toyama, Japan
Local Institution - 0282
Ube Shi, Yamaguchi, Japan
Local Institution - 0341
Nagasaki, , Japan
Local Institution - 0327
Niigata, , Japan
Local Institution - 0354
Okayama, , Japan
Local Institution - 0338
Osaka, , Japan
Local Institution - 0308
Tokyo, , Japan
Local Institution - 0278
Wakayama, , Japan
Local Institution - 0017
Mexico City, D.F., Mexico
Local Institution - 0015
Zapopan, Jalisco, Mexico
Local Institution - 0016
Zapopan, Jalisco, Mexico
Local Institution - 0062
Morelia, Michoacán, Mexico
Local Institution - 0184
Palmerston North, Manawatu-Wanganui, New Zealand
Local Institution - 0101
Hamilton, , New Zealand
Local Institution - 0102
Tauranga, , New Zealand
Local Institution - 0383
Bydgoszcz, , Poland
Local Institution - 0136
Koszalin, , Poland
Local Institution - 0009
Lodz, , Poland
Local Institution - 0013
Lublin, , Poland
Local Institution - 0065
Poznan, , Poland
Local Institution
Warsaw, , Poland
Local Institution - 0095
Warsaw, , Poland
Local Institution - 0329
Rio Piedras, , Puerto Rico
Local Institution - 0359
San Juan, , Puerto Rico
Local Institution - 0041
Cluj-Napoca, Cluj-Napoca, Romania
Local Institution - 0042
Bucharest, , Romania
Local Institution - 0043
Cluj-Napoca, , Romania
Local Institution - 0020
Constanța, , Romania
Local Institution - 0052
Craiova, , Romania
Local Institution - 0035
Timișoara, , Romania
SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, , Russia
SAHI Republican Clinical Oncology Dispensary of MoH of RT
Kazan', , Russia
Clinical Hospital MEDSI in Otradnoye
Krasnogorsk Moscow Region, , Russia
Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the
Moscow, , Russia
Sechenov University
Moscow, , Russia
P.A. Herzen Moscow Oncology Research Institute
Moscow, , Russia
FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre
Obninsk, , Russia
Budgetary Healthcare Institution of Omsk Region ",Clinical Oncological Dispensary",
Omsk, , Russia
Andros Clinic LLC
Saint Petersburg, , Russia
Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A.
Saint Petersburg, , Russia
Local Institution - 0116
Singapore, , Singapore
Local Institution - 0005
Singapore, , Singapore
Local Institution - 0170
Singapore, , Singapore
Local Institution - 0297
Jung-gu, Daejeon, South Korea
Local Institution - 0186
Songnam-si, Gyeonggi-do, South Korea
Local Institution - 0391
Daegu, , South Korea
Local Institution - 0298
Incheon, , South Korea
Local Institution - 0375
Jeollanam-do, , South Korea
Local Institution - 0374
Seodaemun-Gu, , South Korea
Local Institution - 0370
Seoul, , South Korea
Local Institution - 0171
Seoul, , South Korea
Local Institution - 0193
Seoul, , South Korea
Local Institution - 0187
Seoul, , South Korea
Local Institution - 0373
Seoul, , South Korea
Local Institution - 0158
Yangsan, , South Korea
Local Institution - 0141
Manresa, Barcelona, Spain
Local Institution - 0073
Barcelona, , Spain
Local Institution - 0123
Barcelona, , Spain
Local Institution - 0360
Córdoba, , Spain
Local Institution - 0044
Girona, , Spain
Local Institution - 0034
Lugo, , Spain
Local Institution - 0076
Madrid, , Spain
Local Institution - 0024
Madrid, , Spain
Local Institution - 0003
Madrid, , Spain
Local Institution - 0031
Madrid, , Spain
Local Institution - 0364
Madrid, , Spain
Local Institution - 0124
Sabadell (Barcelona), , Spain
Local Institution - 0363
Seville, , Spain
Local Institution - 0192
Niaosng, Kaohsiung, Taiwan
Local Institution - 0194
Taichung, , Taiwan
Local Institution - 0371
Taichung, , Taiwan
Local Institution - 0386
Tainan City, , Taiwan
Local Institution - 0175
Taipei, , Taiwan
Local Institution - 0188
Taipei, , Taiwan
Local Institution - 0094
Adana, , Turkey (Türkiye)
Local Institution - 0119
Ankara, , Turkey (Türkiye)
Local Institution - 0130
Ankara, , Turkey (Türkiye)
Local Institution - 0113
Istanbul, , Turkey (Türkiye)
Local Institution - 0104
Izmir, , Turkey (Türkiye)
Local Institution - 0112
Malatya, , Turkey (Türkiye)
Local Institution - 0173
London, Greater London, United Kingdom
Local Institution - 0098
Manchester, Lancashire, United Kingdom
Local Institution - 0008
Northwood, Middlesex, United Kingdom
Local Institution - 0051
Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0265
Oxford, Oxfordshire, United Kingdom
Local Institution - 0048
Guildford, Surrey, United Kingdom
Local Institution - 0154
London, , United Kingdom
Countries
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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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2019-002030-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-7DX
Identifier Type: -
Identifier Source: org_study_id
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