A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer (CheckMate 7DX)

May 27, 2025 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1030

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Local Institution - 0178
      • Buenos Aires, Argentina, C1012
        • Local Institution - 0185
      • Buenos Aires, Argentina, 1280
        • Local Institution - 0077
      • La Rioja, Argentina, F5300COE
        • Local Institution - 0369
      • San Juan, Argentina, J5402DIL
        • Local Institution - 0394
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7602CBM
        • Local Institution - 0129
      • Pergamino, Buenos Aires, Argentina, B2700
        • Local Institution - 0061
    • Cordoba
      • Parana, Cordoba, Argentina, 5000
        • Local Institution - 0153
      • Rio Cuarto, Cordoba, Argentina, 5800
        • Local Institution - 0393
    • RIO Negro
      • Viedma, RIO Negro, Argentina, 8500
        • Local Institution - 0083
  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Local Institution - 0152
      • Lismore, New South Wales, Australia, 2480
        • Local Institution - 0091
      • Wahroonga, New South Wales, Australia, 2076
        • Local Institution - 0132
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0127
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Local Institution - 0006
      • Woolloongabba, Queensland, Australia, 4102
        • Local Institution - 0084
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Local Institution - 0010
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Local Institution - 0379
      • Frankston, Victoria, Australia, 3199
        • Local Institution - 0040
      • Malvern, Victoria, Australia, 3144
        • Local Institution - 0032
  • Austria
      • Salzburg, Austria, 5020
        • Local Institution - 0038
      • Wien, Austria, 1020
        • Local Institution - 0157
      • Wien, Austria, 1090
        • Local Institution - 0131
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Local Institution - 0118
  • Belgium
      • Brugge, Belgium, 8000
        • Local Institution - 0121
      • Gent, Belgium, 9000
        • Local Institution - 0114
      • Gent, Belgium, 9000
        • Local Institution - 0162
      • Turnhout, Belgium, 2300
        • Local Institution - 0137
      • Wilrijk, Belgium, 2610
        • Local Institution - 0029
    • Brussel
      • Anderlecht, Brussel, Belgium, 1070
        • Local Institution - 0122
  • Brazil
      • Rio de Janeiro, Brazil, 22250-905
        • Local Institution - 0189
      • Rio de Janeiro, Brazil, 22793-080
        • Local Institution - 0060
      • Sao Paulo, Brazil, 01327-0001
        • Local Institution - 0273
      • Sao Paulo, Brazil, 05652- 900
        • Local Institution - 0328
      • Sao Paulo, Brazil, 01321-001
        • Local Institution - 0080
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110022
        • Local Institution - 0097
      • Belo Horizonte, Minas Gerais, Brazil, 30130090
        • Local Institution - 0022
    • Parana
      • Curitiba, Parana, Brazil, 80810050
        • Local Institution - 0082
      • Curitiba, Parana, Brazil, 80530-010
        • Local Institution - 0100
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
        • Local Institution - 0056
    • RS
      • Porto Alegre, RS, Brazil, 90035-001
        • Local Institution - 0063
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Local Institution - 0321
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700-000
        • Local Institution - 0058
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
        • Local Institution - 0057
    • SAO Paulo
      • Campinas, SAO Paulo, Brazil, 13083 970
        • Local Institution - 0086
    • SP
      • Santo Andre, SP, Brazil, 09060-650
        • Local Institution - 0059
    • Sao Paulo
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Local Institution - 0096
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Local Institution - 0151
      • Toronto, Ontario, Canada, M2K 1E1
        • Local Institution - 0191
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Local Institution - 0143
  • Chile
    • Metropolitana
      • Providencia, Metropolitana, Chile, 1234
        • Local Institution - 0378
      • Santiago de Chile, Metropolitana, Chile
        • Local Institution - 0025
      • Santiago de Chile, Metropolitana, Chile, 7500653
        • Local Institution - 0377
    • RM
      • Santiago, RM, Chile, 7630372
        • Local Institution - 0026
    • Valparaiso
      • Vina del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0027
  • China
    • Bei
      • Beijing, Bei, China, 100071
        • Local Institution - 0312
    • Beijing
      • Beijing, Beijing, China, 100020
        • Local Institution - 0245
      • Beijing, Beijing, China, 100050
        • Local Institution - 0337
      • Beijing, Beijing, China, 100730
        • Local Institution - 0345
      • Beijing, Beijing, China, 100036
        • Local Institution - 0254
      • Beijing Shi, Beijing, China, 100034
        • Local Institution - 0140
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Local Institution - 0256
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Local Institution - 0319
    • Hebei
      • Baoding Shi, Hebei, China, 071000
        • Local Institution - 0320
    • Heilongjiang
      • Harbin Shi, Heilongjiang, China, 150081
        • Local Institution - 0224
    • Henan
      • Henan Sheng, Henan, China, 450003
        • Local Institution - 0314
      • Zhengzhou, Henan, China, 450003
        • Local Institution - 0275
    • Hubei
      • Wu Han, Hubei, China, 430000
        • Local Institution - 0313
    • Hunan
      • Changsha, Hunan, China, 410031
        • Local Institution - 0168
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Local Institution - 0165
      • Nanjing, Jiangsu, China, 210009
        • Local Institution - 0317
      • Nanjing, Jiangsu, China, 210009
        • Local Institution - 0325
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0347
      • Nanchang, Jiangxi, China, 330029
        • Local Institution - 0330
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Local Institution - 0161
    • Shandong
      • Jinan, Shandong, China, 250012
        • Local Institution - 0326
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Local Institution - 0155
    • Shannxi
      • Xian, Shannxi, China, 710061
        • Local Institution - 0353
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0253
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Local Institution - 0310
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution - 0316
      • Hangzhou, Zhejiang, China, 310014
        • Local Institution - 0344
  • Czechia
      • Brno, Czechia, 656 53
        • Local Institution - 0108
      • Brno, Czechia, 656 91
        • Local Institution - 0093
      • Olomouc, Czechia, 779 00
        • Local Institution - 0049
      • Ostrava, Czechia, 70852
        • Local Institution - 0088
      • Prague, Czechia, 180 81
        • Local Institution - 0361
      • Praha, Czechia, 140 59
        • Local Institution - 0050
  • France
      • Angers Cedex 02, France, 49055
        • Local Institution - 0107
      • Brest, France, 29200
        • Local Institution - 0202
      • Dijon, France, 21079
        • Local Institution - 0398
      • Hyeres, France, 83400
        • Local Institution - 0030
      • Montpellier, France, 34070
        • Local Institution - 0395
      • Montpellier, France, 34295
        • Local Institution - 0109
      • Nice cedex 2, France, 06189
        • Local Institution - 0384
      • Nimes Cedex 9, France, 30029
        • Local Institution - 0068
      • Paris, France, 75013
        • Local Institution - 0381
      • Paris, France, 75014
        • Local Institution - 0106
      • Paris, France, 75015
        • Local Institution - 0071
      • Pierre-Benite, France, 69310
        • Local Institution - 0133
      • Reims, France, 51100
        • Local Institution - 0399
      • Rennes, France, 35042 Rennes
        • Local Institution - 0380
      • Strasbourg, France, 67000
        • Local Institution - 0387
      • Villejuif Cedex, France, 94805
        • Local Institution - 0271
    • Alsace
      • Strasbourg, Alsace, France, 67200
        • Local Institution - 0105
    • Nord
      • Lille, Nord, France, 59020
        • Local Institution - 0079
    • Sarthe
      • Le Mans, Sarthe, France, 72000
        • Local Institution - 0167
  • Germany
      • Bonn, Germany, 53127
        • Local Institution - 0089
      • Duesseldorf, Germany, 40225
        • Local Institution - 0376
      • Emmendingen, Germany, 79312
        • Local Institution - 0172
      • Erlangen, Germany, 91054
        • Local Institution - 0142
      • Frankfurt am Main, Germany, 60590
        • Local Institution - 0018
      • Hamburg, Germany, 20246
        • Local Institution - 0064
      • Hamburg, Germany, 22763
        • Local Institution - 0069
      • Heidelberg, Germany, 69120
        • Local Institution - 0389
      • Magdeburg, Germany, 39120
        • Local Institution - 0004
      • Marburg, Germany, 35043
        • Local Institution - 0372
      • Muenchen, Germany, 81675
        • Local Institution - 0204
      • Muenster, Germany, 48149
        • Local Institution - 0036
      • Tuebingen, Germany, 72076
        • Local Institution - 0169
    • Baden-Wuerttemberg
      • Nuertingen, Baden-Wuerttemberg, Germany, 72622
        • Local Institution - 0023
    • Rheinland Pfa
      • Koblenz, Rheinland Pfa, Germany, 56068
        • Local Institution - 0014
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Local Institution - 0090
  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Local Institution - 0145
      • Hong Kong, Hong Kong, NT
        • Local Institution - 0045
      • Hong Kong, Hong Kong
        • Local Institution - 0146
  • Israel
      • Haifa, Israel, 3109601
        • Local Institution - 0072
      • Jerusalem, Israel, 9112001
        • Local Institution - 0388
      • Kfar Saba, Israel, 4428164
        • Local Institution - 0368
      • Petach tikva, Israel, 4941492
        • Local Institution - 0128
      • Ramat Gan, Israel, 5265601
        • Local Institution - 0135
      • Tel Aviv, Israel, 6423906
        • Local Institution - 0138
  • Italy
      • Benevento, Italy, 82100
        • Local Institution - 0099
      • Bergamo, Italy, 24127
        • Local Institution - 0001
      • Bologna, Italy, 40138
        • Local Institution - 0111
      • Brescia, Italy, 25123
        • Local Institution - 0039
      • Cremona, Italy, 26100
        • Local Institution - 0053
      • Milan, Italy, 20141
        • Local Institution - 0066
      • Napoli, Italy, 80131
        • Local Institution - 0120
      • Orbassano, Italy, 10043
        • Local Institution - 0070
      • Parma, Italy, 43126
        • Local Institution - 0037
      • Pisa, Italy, 56126
        • Local Institution - 0199
      • Rome, Italy, 00128
        • Local Institution - 0046
      • Rome, Italy, 00152
        • Local Institution - 0385
      • Trento, Italy, 38122
        • Local Institution - 0067
  • Japan
      • Nagasaki, Japan, 8528501
        • Local Institution - 0341
      • Niigata, Japan, 951-8520
        • Local Institution - 0327
      • Okayama, Japan, 7000914
        • Local Institution - 0354
      • Osaka, Japan, 565-0871
        • Local Institution - 0338
      • Tokyo, Japan, 1608582
        • Local Institution - 0308
      • Wakayama, Japan, 641-8510
        • Local Institution - 0278
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4678602
        • Local Institution - 0362
    • Akita
      • Akita-shi, Akita, Japan, 010-8543
        • Local Institution - 0340
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8563
        • Local Institution - 0358
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Local Institution - 0346
      • Sakura-Shi, Chiba, Japan, 285-8741
        • Local Institution - 0339
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 791-0280
        • Local Institution - 0307
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8128582
        • Local Institution - 0280
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608543
        • Local Institution - 0281
      • Sapporo-shi, Hokkaido, Japan, 608648
        • Local Institution - 0296
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan, 2320024
        • Local Institution - 0283
    • Kumamoto
      • Kumamoto-Shi, Kumamoto, Japan, 860-0008
        • Local Institution - 0324
    • Kyoto
      • Kamigyo-ku, Kyoto, Japan, 602-8566
        • Local Institution - 0342
    • Nara
      • Kashihara-shi, Nara, Japan, 6348522
        • Local Institution - 0355
    • Osaka
      • Osaka Sayama, Osaka, Japan, 5898511
        • Local Institution - 0323
      • Osaka shi, Osaka, Japan, 5418567
        • Local Institution - 0343
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Local Institution - 0309
    • Toyama
      • Toyama-shi, Toyama, Japan, 9300194
        • Local Institution - 0279
    • Yamaguchi
      • Ube shi, Yamaguchi, Japan, 7550046
        • Local Institution - 0282
  • Korea, Republic of
      • Daegu, Korea, Republic of, 42601
        • Local Institution - 0391
      • Incheon, Korea, Republic of, 405-760
        • Local Institution - 0298
      • Jeollanam-do, Korea, Republic of, 58128
        • Local Institution - 0375
      • Seodaemun-Gu, Korea, Republic of, 3722
        • Local Institution - 0374
      • Seoul, Korea, Republic of, 02841
        • Local Institution - 0370
      • Seoul, Korea, Republic of, 03080
        • Local Institution - 0171
      • Seoul, Korea, Republic of, 05505
        • Local Institution - 0193
      • Seoul, Korea, Republic of, 06351
        • Local Institution - 0187
      • Seoul, Korea, Republic of, 6591
        • Local Institution - 0373
      • Yangsan Si, Korea, Republic of, 50612
        • Local Institution - 0158
    • Daejeon
      • Jung-gu, Daejeon, Korea, Republic of, 35015
        • Local Institution - 0297
    • Gyeonggi-do
      • Songnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Local Institution - 0186
  • Mexico
    • D.f.
      • Mexico City, D.f., Mexico, 3100
        • Local Institution - 0017
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45030
        • Local Institution - 0015
      • Zapopan, Jalisco, Mexico, 45070
        • Local Institution - 0016
    • Michoacan
      • Morelia, Michoacan, Mexico, 58260
        • Local Institution - 0062
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Local Institution - 0101
      • Tauranga, New Zealand, 3112
        • Local Institution - 0102
    • Manawatu-Wanganui
      • Palmerston North, Manawatu-Wanganui, New Zealand, 4414
        • Local Institution - 0184
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Local Institution - 0383
      • Koszalin, Poland, 75-581
        • Local Institution - 0136
      • Lodz, Poland, 93-513
        • Local Institution - 0009
      • Lublin, Poland, 20-090
        • Local Institution - 0013
      • Poznan, Poland, 60-848
        • Local Institution - 0065
      • Warsaw, Poland, 02 797
        • Local Institution
      • Warszawa, Poland, 04-073
        • Local Institution - 0095
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Local Institution - 0329
      • San Juan, Puerto Rico, 00927
        • Local Institution - 0359
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0042
      • Cluj Napoca, Romania, 400015
        • Local Institution - 0043
      • Constanta, Romania, 900591
        • Local Institution - 0020
      • Craiova, Romania, 200347
        • Local Institution - 0052
      • Timisoara, Romania, 300425
        • Local Institution - 0035
    • Cluj-Napoca
      • Cluj, Cluj-Napoca, Romania, 400015
        • Local Institution - 0041
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
      • Kazan, Russian Federation, 163045
        • SAHI Republican Clinical Oncology Dispensary of MoH of RT
      • Krasnogorsk Moscow Region, Russian Federation, 143442
        • Clinical Hospital MEDSI in Otradnoye
      • Moscow, Russian Federation, 119435
        • Sechenov University
      • Moscow, Russian Federation, 115478
        • Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the
      • Moscow, Russian Federation, 125284
        • P.A. Herzen Moscow Oncology Research Institute
      • Obninsk, Russian Federation, 249036
        • FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre
      • Omsk, Russian Federation, 644013
        • Budgetary Healthcare Institution of Omsk Region &quot,Clinical Oncological Dispensary&quot,
      • Saint-Petersburg, Russian Federation, 197136
        • Andros Clinic LLC
      • Saint-Petersburg, Russian Federation, 197758
        • Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A.
  • Singapore
      • Singapore, Singapore, 169610
        • Local Institution - 0116
      • Singapore, Singapore, 258499
        • Local Institution - 0005
      • Singapore, Singapore, 308430
        • Local Institution - 0170
  • Spain
      • Barcelona, Spain, 08916
        • Local Institution - 0073
      • Barcelona, Spain, 8908
        • Local Institution - 0123
      • Cordoba, Spain, 14004
        • Local Institution - 0360
      • Girona, Spain, 17007
        • Local Institution - 0044
      • Lugo, Spain, 27003
        • Local Institution - 0034
      • Madrid, Spain, 28006
        • Local Institution - 0076
      • Madrid, Spain, 28033
        • Local Institution - 0024
      • Madrid, Spain, 28034
        • Local Institution - 0003
      • Madrid, Spain, 28041
        • Local Institution - 0031
      • Madrid, Spain, 28222
        • Local Institution - 0364
      • Sabadell (Barcelona), Spain, 08208
        • Local Institution - 0124
      • Sevilla, Spain, 41013
        • Local Institution - 0363
    • Barcelona
      • Manresa, Barcelona, Spain, 8243
        • Local Institution - 0141
  • Taiwan
      • Taichung, Taiwan, 404
        • Local Institution - 0194
      • Taichung, Taiwan, 40705
        • Local Institution - 0371
      • Tainan, Taiwan, 704
        • Local Institution - 0386
      • Taipei, Taiwan, 10002
        • Local Institution - 0175
      • Taipei, Taiwan, 111217
        • Local Institution - 0188
    • Kaohsiung
      • Niaosng, Kaohsiung, Taiwan, 833
        • Local Institution - 0192
  • Turkey
      • Adana, Turkey, 01330
        • Local Institution - 0094
      • Ankara, Turkey, 06620
        • Local Institution - 0119
      • Ankara, Turkey, 6100
        • Local Institution - 0130
      • Istanbul, Turkey, 34098
        • Local Institution - 0113
      • Izmir, Turkey, 35575
        • Local Institution - 0104
      • Malatya, Turkey, 44280
        • Local Institution - 0112
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • Local Institution - 0154
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution - 0173
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M20 4BX
        • Local Institution - 0098
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Local Institution - 0008
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Local Institution - 0051
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX4 6LB
        • Local Institution - 0265
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Local Institution - 0048
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608-1753
        • Local Institution - 0305
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Local Institution - 0012
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Local Institution - 0293
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Local Institution - 0269
    • California
      • Orange, California, United States, 92868
        • Local Institution - 0179
      • Rancho Mirage, California, United States, 92270
        • Local Institution - 0055
      • Redondo Beach, California, United States, 90277
        • Local Institution - 0260
      • Santa Monica, California, United States, 90404
        • Local Institution - 0081
    • Colorado
      • Denver, Colorado, United States, 80211-5222
        • Local Institution - 0087
    • Connecticut
      • West Haven, Connecticut, United States, 06516-5907
        • Local Institution - 0190
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-3017
        • Local Institution - 0366
    • Florida
      • Hollywood, Florida, United States, 33021
        • Local Institution - 0196
      • Jacksonville, Florida, United States, 32256
        • Local Institution - 0397
      • Lakeland, Florida, United States, 33805
        • Local Institution - 0164
      • Orlando, Florida, United States, 32806
        • Local Institution - 0181
      • Pensacola, Florida, United States, 32503
        • Local Institution - 0285
      • Weston, Florida, United States, 33331
        • Local Institution - 0177
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0117
      • Marietta, Georgia, United States, 30060
        • Local Institution - 0126
      • Thomasville, Georgia, United States, 31792
        • Local Institution - 0382
    • Illinois
      • Niles, Illinois, United States, 60714
        • Local Institution - 0287
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Local Institution - 0183
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Local Institution - 0302
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Local Institution - 0150
      • Brandywine, Maryland, United States, 20613
        • Local Institution - 0332
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 0299
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Local Institution - 0365
      • Florham Park, New Jersey, United States, 07932
        • Local Institution - 0139
    • New York
      • Albany, New York, United States, 12208
        • Local Institution - 0300
      • Port Jefferson Station, New York, United States, 11776
        • Local Institution - 0028
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0333
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103-6218
        • Local Institution - 0180
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Local Institution - 0074
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0292
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Local Institution - 0233
      • Myrtle Beach, South Carolina, United States, 29572-4607
        • Local Institution - 0115
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Local Institution - 0149
    • Texas
      • Austin, Texas, United States, 75251
        • Local Institution - 0286
      • Dallas, Texas, United States, 75251
        • Local Institution - 0303
      • Houston, Texas, United States, 77024-2843
        • Local Institution - 0284
      • Houston, Texas, United States, 77030-3721
        • Local Institution - 0195
      • San Antonio, Texas, United States, 78229
        • Local Institution - 0011
      • Tyler, Texas, United States, 75701
        • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 0110
      • Spokane, Washington, United States, 99208
        • Local Institution - 0289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologic confirmation of adenocarcinoma of the prostate without small cell features
  • 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 brain metastases
  • 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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Nivolumab + docetaxel + prednisone
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558-01
  • OPDIVO,
Drug: Docetaxel
Specified dose on specified days
Drug: Prednisone
Specified dose on specified days
Placebo Comparator: Arm B: Placebo + docetaxel + prednisone
Other: Placebo
Specified dose on specified days
Drug: Docetaxel
Specified dose on specified days
Drug: Prednisone
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)
Time Frame: from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)
rPFS for randomized participants is the time between randomization and the first date of documented progression or death due to any cause, whichever occurs first. The rPFS was censored at the last radiographic tumor assessment up to the start of subsequent cancer therapy for those without progression or death. It was also censored at the date of last radiographic tumor assessment prior to the missed tumor assessments for participants who had progressive disease (PD) or death immediately after more than one consecutive missed tumor assessments. Radiographic progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)
Overall Survival (OS)
Time Frame: From randomization to the date of death from any cause (Up to approximately 31 months)
OS for all randomized participants is the time between randomization and the date of death from any cause. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.
From randomization to the date of death from any cause (Up to approximately 31 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to PSA Progression (TTP-PSA)
Time Frame: from randomization to the date of PSA Progression (Up to approximately 31 months)
Time to PSA Progression (TTP-PSA) is the time between randomization to the date of PSA progression per PCWG3 in randomized participants. PSA Progression: For participants with an initial PSA decline from baseline, the date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir are documented and confirmed by a second consecutive PSA value at least 3 weeks later. For participants with no PSA decline from baseline, the date of PSA progression is date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from baseline are documented at or beyond Week 13. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. Censored at date of last PSA evaluation on/prior to start of subsequent cancer therapy.
from randomization to the date of PSA Progression (Up to approximately 31 months)
Number of Participants With Endocrine Immune-Mediated Adverse Events
Time Frame: From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Time Frame: From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Time Frame: From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
Blood samples were collected for conducting specific thyroid test. Baseline is defined as evaluations or events that occur before the date and time of the first dose of study treatment. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF)
Time Frame: From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months
The BPI-SF is an instrument to assess pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire designed to assess severity and impact of pain on daily function. Participants rate severity of pain at its "worst," "least," and "average" in last 24 hours using an 11-point numerical rating scale with anchors of "no pain" and "pain as bad. The participant's assessment of pain with BPI-SF Item number 3 (pain symptoms at their worst over the last 24 hours) form basis for analysis. Time to pain progression is time between date of randomization and date of first increase in worst pain intensity. Pain progression occurred if an increase in worst pain intensity of >= 2 points is observed from baseline and maintained over 2 consecutive time periods. Baseline was evaluations or events that occur before date and time of first dose of study treatment or evaluations on same date and time of first dose of study treatment were also considered as baseline.
From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
Time Frame: From date of randomization to the date of objectively documented progression per PCWG3 or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 52 months)
Objective Response Rate per PCWG3 (ORR-PCWG3) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
From date of randomization to the date of objectively documented progression per PCWG3 or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 52 months)
Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
Time Frame: From randomization to the date of the first documented CR or PR (Up to approximately 52 months)
Time to Response per PCWG3 (TTR-PCWG3) is the time from randomization to the date of the first documented CR or PR per PCWG3, as determined by BICR. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From randomization to the date of the first documented CR or PR (Up to approximately 52 months)
Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
Time Frame: From randomization date to the date of first documented radiographic progression or death due to any cause whichever occurs first (Up to approximately 52 months)
Duration of Response per PCWG3 (DOR-PCWG3) is time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3,as determined by BICR, or death due to any cause whichever occurs first. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Radiographic progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
From randomization date to the date of first documented radiographic progression or death due to any cause whichever occurs first (Up to approximately 52 months)
Prostate-specific Antigen (PSA) Response Rate (PSA-RR)
Time Frame: Up to approximately 52 months
PSA Response Rate (PSA-RR) is the percentage of randomized participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
Up to approximately 52 months
Number of Participants With Adverse Events
Time Frame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
Number of Participants With Serious Adverse Events
Time Frame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death or Is life-threatening or requires inpatient hospitalization or causes prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
Number of Participants With Adverse Events Leading to Discontinuation
Time Frame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
Number of Participants With Select Adverse Events
Time Frame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
Number of Participants Who Died
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
Time Frame: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)
The severity of laboratory test results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 0 is defined as absence of an AE or within normal limits; Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening. Number of participants with worst grade change results to Grade 3 or Grade 4 laboratory test results is presented. E.g., the row title HEMOGLOBIN Grade 0 to Grade 3, Grade 0 is baseline and Grade 3 is post baseline.
From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2020

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 25, 2024

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-7DX
  • 2019-002030-36 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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