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

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: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Placebo; Biological: Nivolumab; Drug: Docetaxel; Drug: Prednisone

• Study Type: Interventional
• Enrollment (Estimated): 984
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

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, 82305-100
      • 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, 100142
      • Local Institution - 0254
    • Beijing, Beijing, China, 100730
      • Local Institution - 0345
    • 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
    • Local Institution - 0146
  • Hong Kong, Hong Kong, 852
    • Local Institution - 0145
  • Hong Kong, Hong Kong, NT
    • Local Institution - 0045
• 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
  • Palmerston North, New Zealand, 4414
    • Local Institution - 0184
  • Tauranga, New Zealand, 3112
    • Local Institution - 0102
• Poland
  • 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
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
      • Local Institution - 0383
• 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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 (PCWG3)	Up to 530 rPFS events	From the date of randomization to the first date of documented progression or death due to any cause, whichever occurs first, approximately 31 months
Overall Survival (OS)		From the date of randomization to the date of death from any cause, approximately 51 months. For participants who are alive, their survival time will be censored at the last date that they were known to be alive

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR) per PCWG3	From the date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first, approximately 31 months
Time to Response per PCWG3 (TTR-PCWG3) determined by BICR	From the date of randomization to the date of the first documented complete response (CR) or partial response (PR), approximately 31 months
Duration of Response (DOR) per PCWG3 determined by BICR	From the date of first response (CR/PR) to the date of first documented radiographic progression, or death due to any cause, approximately 31 months
Prostate-specific antigen (PSA) Response Rate (PSA-RR)	Approximately 31 months
Time to PSA Progression (TTP-PSA)	From date of randomization to the date of PSA progression per PCWG3, approximately 31 months
Incidence of Adverse Events (AEs)	Approximately 31 months
Incidence of Serious Adverse Events (SAEs)	Approximately 31 months
Incidence of AEs leading to discontinuation	Approximately 31 months
Incidence of immune-mediated AEs	Approximately 31 months
Incidence of deaths	Approximately 31 months
Incidence of laboratory abnormalities: Clinical Chemistry Tests	Approximately 31 months
Incidence of laboratory abnormalities: Hematology tests	Approximately 31 months
Incidence of laboratory abnormalities: Serology tests	Approximately 31 months
Median time to pain progression assessed by Brief Pain Inventory-Short Form (BPI-SF)	Approximately 31 months
Incidence of changes from baseline in Physical Exam	Approximately 31 months
Incidence of changes from baseline in vital signs: Respiratory rate	Approximately 31 months
Incidence of changes from baseline in vital signs: Body temperature	Approximately 31 months
Incidence of changes from baseline in vital signs: Blood pressure	Approximately 31 months
Incidence of changes from baseline in vital signs: Heart Rate	Approximately 31 months
Incidence of changes from baseline electrocardiogram (ECG)	Approximately 31 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 30, 2028

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 (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Docetaxel; Nivolumab; Prednisone
• 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