Prostate Cancer Clinical Trial

A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

984

Study ID:

NCT04100018

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 283 Locations for this study

See Locations Near You

Local Institution - 0305
Mobile Alabama, 36608, United States
Local Institution - 0012
Anchorage Alaska, 99503, United States
Local Institution - 0293
Tucson Arizona, 85724, United States
Local Institution - 0269
Jonesboro Arkansas, 72401, United States
Local Institution - 0179
Orange California, 92868, United States
Local Institution - 0055
Rancho Mirage California, 92270, United States
Local Institution - 0260
Redondo Beach California, 90277, United States
Local Institution - 0081
Santa Monica California, 90404, United States
Local Institution - 0087
Denver Colorado, 80211, United States
Local Institution - 0190
West Haven Connecticut, 06516, United States
Local Institution - 0366
Washington District of Columbia, 20010, United States
Local Institution - 0196
Hollywood Florida, 33021, United States
Local Institution - 0397
Jacksonville Florida, 32256, United States
Local Institution - 0164
Lakeland Florida, 33805, United States
Local Institution - 0181
Orlando Florida, 32806, United States
Local Institution - 0285
Pensacola Florida, 32503, United States
Local Institution - 0177
Weston Florida, 33331, United States
Local Institution - 0117
Atlanta Georgia, 30342, United States
Local Institution - 0126
Marietta Georgia, 30060, United States
Local Institution - 0382
Thomasville Georgia, 31792, United States
Local Institution - 0287
Niles Illinois, 60714, United States
Local Institution - 0183
Fort Wayne Indiana, 46804, United States
Local Institution - 0302
Louisville Kentucky, 40202, United States
Local Institution - 0150
Baltimore Maryland, 21201, United States
Local Institution - 0332
Brandywine Maryland, 20613, United States
Local Institution - 0299
Omaha Nebraska, 68130, United States
Local Institution - 0365
East Brunswick New Jersey, 08816, United States
Local Institution - 0139
Florham Park New Jersey, 07932, United States
Local Institution - 0300
Albany New York, 12208, United States
Local Institution - 0028
Port Jefferson Station New York, 11776, United States
Local Institution - 0333
Columbus Ohio, 43210, United States
Local Institution - 0180
Allentown Pennsylvania, 18103, United States
Local Institution - 0074
Bala-Cynwyd Pennsylvania, 19004, United States
Local Institution - 0292
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 0233
Charleston South Carolina, 29414, United States
Local Institution - 0115
Myrtle Beach South Carolina, 29572, United States
Local Institution - 0149
Germantown Tennessee, 38138, United States
Local Institution - 0286
Austin Texas, 75251, United States
Local Institution - 0303
Dallas Texas, 75251, United States
Local Institution - 0284
Houston Texas, 77024, United States
Local Institution - 0195
Houston Texas, 77030, United States
Local Institution - 0011
San Antonio Texas, 78229, United States
The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center
Tyler Texas, 75701, United States
Local Institution - 0110
Seattle Washington, 98109, United States
Local Institution - 0289
Spokane Washington, 99208, United States
Local Institution - 0129
Mar del Plata Buenos Aires, B7602, Argentina
Local Institution - 0061
Pergamino Buenos Aires, B2700, Argentina
Local Institution - 0153
Parana Cordoba, 5000, Argentina
Local Institution - 0393
Rio Cuarto Cordoba, 5800, Argentina
Local Institution - 0083
Viedma RIO Negro, 8500, Argentina
Local Institution - 0077
Buenos Aires , 1280, Argentina
Local Institution - 0178
Buenos Aires , 1426, Argentina
Local Institution - 0185
Buenos Aires , C1012, Argentina
Local Institution - 0369
La Rioja , F5300, Argentina
Local Institution - 0394
San Juan , J5402, Argentina
Local Institution - 0152
Gosford New South Wales, 2250, Australia
Local Institution - 0091
Lismore New South Wales, 2480, Australia
Local Institution - 0132
Wahroonga New South Wales, 2076, Australia
Local Institution - 0127
Westmead New South Wales, 2145, Australia
Local Institution - 0006
South Brisbane Queensland, 4101, Australia
Local Institution - 0084
Woolloongabba Queensland, 4102, Australia
Local Institution - 0010
North Adelaide South Australia, 5006, Australia
Local Institution - 0379
Ballarat Victoria, 3350, Australia
Local Institution - 0040
Frankston Victoria, 3199, Australia
Local Institution - 0032
Malvern Victoria, 3144, Australia
Local Institution - 0118
Linz Upper Austria, 4020, Austria
Local Institution - 0038
Salzburg , 5020, Austria
Local Institution - 0157
Wien , 1020, Austria
Local Institution - 0131
Wien , 1090, Austria
Local Institution - 0122
Anderlecht Brussel, 1070, Belgium
Local Institution - 0121
Brugge , 8000, Belgium
Local Institution - 0114
Gent , 9000, Belgium
Local Institution - 0162
Gent , 9000, Belgium
Local Institution - 0137
Turnhout , 2300, Belgium
Local Institution - 0029
Wilrijk , 2610, Belgium
Local Institution - 0097
Belo Horizonte Minas Gerais, 30110, Brazil
Local Institution - 0022
Belo Horizonte Minas Gerais, 30130, Brazil
Local Institution - 0082
Curitiba Parana, 80810, Brazil
Local Institution - 0100
Curitiba Parana, 82305, Brazil
Local Institution - 0321
Natal Rio Grande Do Norte, 59075, Brazil
Local Institution - 0058
Ijui Rio Grande Do Sul, 98700, Brazil
Local Institution - 0056
Porto Alegre RIO Grande DO SUL, 90035, Brazil
Local Institution - 0057
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Local Institution - 0063
Porto Alegre RS, 90035, Brazil
Local Institution - 0086
Campinas SAO Paulo, 13083, Brazil
Local Institution - 0096
Sao Jose Do Rio Preto Sao Paulo, 15090, Brazil
Local Institution - 0059
Santo Andre SP, 09060, Brazil
Local Institution - 0189
Rio de Janeiro , 22250, Brazil
Local Institution - 0060
Rio de Janeiro , 22793, Brazil
Local Institution - 0080
Sao Paulo , 01321, Brazil
Local Institution - 0273
Sao Paulo , 01327, Brazil
Local Institution - 0328
Sao Paulo , 05652, Brazil
Local Institution - 0151
Brampton Ontario, L6R 3, Canada
Local Institution - 0191
Toronto Ontario, M2K 1, Canada
Local Institution - 0143
Montreal Quebec, H2X 0, Canada
Local Institution - 0378
Providencia Metropolitana, 1234, Chile
Local Institution - 0025
Santiago de Chile Metropolitana, 0, Chile
Local Institution - 0377
Santiago de Chile Metropolitana, 75006, Chile
Local Institution - 0026
Santiago RM, 76303, Chile
Local Institution - 0027
Vina del Mar Valparaiso, 25205, Chile
Local Institution - 0140
Beijing Shi Beijing, 10003, China
Local Institution - 0245
Beijing Beijing, 10002, China
Local Institution - 0337
Beijing Beijing, 10005, China
Local Institution - 0254
Beijing Beijing, 10014, China
Local Institution - 0345
Beijing Beijing, 10073, China
Local Institution - 0312
Beijing Bei, 10007, China
Local Institution - 0256
Fuzhou Fujian, 35000, China
Local Institution - 0319
Guangzhou Guangdong, 51000, China
Local Institution - 0320
Baoding Shi Hebei, 07100, China
Local Institution - 0224
Harbin Shi Heilongjiang, 15008, China
Local Institution - 0314
Henan Sheng Henan, 45000, China
Local Institution - 0275
Zhengzhou Henan, 45000, China
Local Institution - 0313
Wu Han Hubei, 43000, China
Local Institution - 0168
Changsha Hunan, 41003, China
Local Institution - 0165
Nanjing Jiangsu, 21000, China
Local Institution - 0317
Nanjing Jiangsu, 21000, China
Local Institution - 0325
Nanjing Jiangsu, 21000, China
Local Institution - 0347
Nanchang Jiangxi, 33000, China
Local Institution - 0330
Nanchang Jiangxi, 33002, China
Local Institution - 0161
Shenyang Liaoning, 11004, China
Local Institution - 0326
Jinan Shandong, 25001, China
Local Institution - 0155
Shanghai Shanghai, 20003, China
Local Institution - 0353
Xian Shannxi, 71006, China
Local Institution - 0253
Chengdu Sichuan, 61004, China
Local Institution - 0310
Urumqi Xinjiang, 83001, China
Local Institution - 0316
Hangzhou Zhejiang, 31000, China
Local Institution - 0344
Hangzhou Zhejiang, 31001, China
Local Institution - 0108
Brno , 656 5, Czechia
Local Institution - 0093
Brno , 656 9, Czechia
Local Institution - 0049
Olomouc , 779 0, Czechia
Local Institution - 0088
Ostrava , 70852, Czechia
Local Institution - 0361
Prague , 180 8, Czechia
Local Institution - 0050
Praha , 140 5, Czechia
Local Institution - 0105
Strasbourg Alsace, 67200, France
Local Institution - 0079
Lille Nord, 59020, France
Local Institution - 0167
Le Mans Sarthe, 72000, France
Local Institution - 0107
Angers Cedex 02 , 49055, France
Local Institution - 0202
Brest , 29200, France
Local Institution - 0398
Dijon , 21079, France
Local Institution - 0030
Hyeres , 83400, France
Local Institution - 0395
Montpellier , 34070, France
Local Institution - 0109
Montpellier , 34295, France
Local Institution - 0384
Nice cedex 2 , 06189, France
Local Institution - 0068
Nimes Cedex 9 , 30029, France
Local Institution - 0381
Paris , 75013, France
Local Institution - 0106
Paris , 75014, France
Local Institution - 0071
Paris , 75015, France
Local Institution - 0133
Pierre-Benite , 69310, France
Local Institution - 0399
Reims , 51100, France
Local Institution - 0380
Rennes , 35042, France
Local Institution - 0387
Strasbourg , 67000, France
Local Institution - 0271
Villejuif Cedex , 94805, France
Local Institution - 0023
Nuertingen Baden-Wuerttemberg, 72622, Germany
Local Institution - 0014
Koblenz Rheinland Pfa, 56068, Germany
Local Institution - 0090
Dresden Saxony, 01307, Germany
Local Institution - 0089
Bonn , 53127, Germany
Local Institution - 0376
Duesseldorf , 40225, Germany
Local Institution - 0172
Emmendingen , 79312, Germany
Local Institution - 0142
Erlangen , 91054, Germany
Local Institution - 0018
Frankfurt am Main , 60590, Germany
Local Institution - 0064
Hamburg , 20246, Germany
Local Institution - 0069
Hamburg , 22763, Germany
Local Institution - 0389
Heidelberg , 69120, Germany
Local Institution - 0004
Magdeburg , 39120, Germany
Local Institution - 0372
Marburg , 35043, Germany
Local Institution - 0204
Muenchen , 81675, Germany
Local Institution - 0036
Muenster , 48149, Germany
Local Institution - 0169
Tuebingen , 72076, Germany
Local Institution - 0146
Hong Kong , 0, Hong Kong
Local Institution - 0145
Hong Kong , 852, Hong Kong
Local Institution - 0045
Hong Kong , NT, Hong Kong
Local Institution - 0072
Haifa , 31096, Israel
Local Institution - 0388
Jerusalem , 91120, Israel
Local Institution - 0368
Kfar Saba , 44281, Israel
Local Institution - 0128
Petach tikva , 49414, Israel
Local Institution - 0135
Ramat Gan , 52656, Israel
Local Institution - 0138
Tel Aviv , 64239, Israel
Local Institution - 0099
Benevento , 82100, Italy
Local Institution - 0001
Bergamo , 24127, Italy
Local Institution - 0111
Bologna , 40138, Italy
Local Institution - 0039
Brescia , 25123, Italy
Local Institution - 0053
Cremona , 26100, Italy
Local Institution - 0066
Milan , 20141, Italy
Local Institution - 0120
Napoli , 80131, Italy
Local Institution - 0070
Orbassano , 10043, Italy
Local Institution - 0037
Parma , 43126, Italy
Local Institution - 0199
Pisa , 56126, Italy
Local Institution - 0046
Rome , 00128, Italy
Local Institution - 0385
Rome , 00152, Italy
Local Institution - 0067
Trento , 38122, Italy
Local Institution - 0362
Nagoya-shi Aichi, 46786, Japan
Local Institution - 0340
Akita-shi Akita, 010-8, Japan
Local Institution - 0358
Hirosaki-shi Aomori, 036-8, Japan
Local Institution - 0346
Chiba-shi Chiba, 260-8, Japan
Local Institution - 0339
Sakura-Shi Chiba, 285-8, Japan
Local Institution - 0307
Matsuyama-shi Ehime, 791-0, Japan
Local Institution - 0280
Fukuoka-shi Fukuoka, 81285, Japan
Local Institution - 0296
Sapporo-shi Hokkaido, 60864, Japan
Local Institution - 0281
Sapporo Hokkaido, 06085, Japan
Local Institution - 0283
Yokohama-shi Kanagawa, 23200, Japan
Local Institution - 0324
Kumamoto-Shi Kumamoto, 860-0, Japan
Local Institution - 0342
Kamigyo-ku Kyoto, 602-8, Japan
Local Institution - 0355
Kashihara-shi Nara, 63485, Japan
Local Institution - 0323
Osaka Sayama Osaka, 58985, Japan
Local Institution - 0343
Osaka shi Osaka, 54185, Japan
Local Institution - 0309
Hamamatsu Shizuoka, 431-3, Japan
Local Institution - 0279
Toyama-shi Toyama, 93001, Japan
Local Institution - 0282
Ube shi Yamaguchi, 75500, Japan
Local Institution - 0341
Nagasaki , 85285, Japan
Local Institution - 0327
Niigata , 951-8, Japan
Local Institution - 0354
Okayama , 70009, Japan
Local Institution - 0338
Osaka , 565-0, Japan
Local Institution - 0308
Tokyo , 16085, Japan
Local Institution - 0278
Wakayama , 641-8, Japan
Local Institution - 0297
Jung-gu Daejeon, 35015, Korea, Republic of
Local Institution - 0186
Songnam-si Gyeonggi-do, 13620, Korea, Republic of
Local Institution - 0391
Daegu , 42601, Korea, Republic of
Local Institution - 0298
Incheon , 405-7, Korea, Republic of
Local Institution - 0375
Jeollanam-do , 58128, Korea, Republic of
Local Institution - 0374
Seodaemun-Gu , 3722, Korea, Republic of
Local Institution - 0370
Seoul , 02841, Korea, Republic of
Local Institution - 0171
Seoul , 03080, Korea, Republic of
Local Institution - 0193
Seoul , 05505, Korea, Republic of
Local Institution - 0187
Seoul , 06351, Korea, Republic of
Local Institution - 0373
Seoul , 6591, Korea, Republic of
Local Institution - 0158
Yangsan Si , 50612, Korea, Republic of
Local Institution - 0017
Mexico City D.f., 3100, Mexico
Local Institution - 0015
Zapopan Jalisco, 45030, Mexico
Local Institution - 0016
Zapopan Jalisco, 45070, Mexico
Local Institution - 0062
Morelia Michoacan, 58260, Mexico
Local Institution - 0101
Hamilton , 3204, New Zealand
Local Institution - 0184
Palmerston North , 4414, New Zealand
Local Institution - 0102
Tauranga , 3112, New Zealand
Local Institution - 0383
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Local Institution - 0136
Koszalin , 75-58, Poland
Local Institution - 0009
Lodz , 93-51, Poland
Local Institution - 0013
Lublin , 20-09, Poland
Local Institution - 0065
Poznan , 60-84, Poland
Local Institution
Warsaw , 02 79, Poland
Local Institution - 0095
Warszawa , 04-07, Poland
Local Institution - 0329
Rio Piedras , 00935, Puerto Rico
Local Institution - 0359
San Juan , 00927, Puerto Rico
Local Institution - 0041
Cluj Cluj-Napoca, 40001, Romania
Local Institution - 0042
Bucharest , 02232, Romania
Local Institution - 0043
Cluj Napoca , 40001, Romania
Local Institution - 0020
Constanta , 90059, Romania
Local Institution - 0052
Craiova , 20034, Romania
Local Institution - 0035
Timisoara , 30042, Romania
SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk , 16304, Russian Federation
SAHI Republican Clinical Oncology Dispensary of MoH of RT
Kazan , 16304, Russian Federation
Clinical Hospital MEDSI in Otradnoye
Krasnogorsk Moscow Region , 14344, Russian Federation
Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the
Moscow , 11547, Russian Federation
Sechenov University
Moscow , 11943, Russian Federation
P.A. Herzen Moscow Oncology Research Institute
Moscow , 12528, Russian Federation
FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre
Obninsk , 24903, Russian Federation
Budgetary Healthcare Institution of Omsk Region ",Clinical Oncological Dispensary",
Omsk , 64401, Russian Federation
Andros Clinic LLC
Saint-Petersburg , 19713, Russian Federation
Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A.
Saint-Petersburg , 19775, Russian Federation
Local Institution - 0116
Singapore , 16961, Singapore
Local Institution - 0005
Singapore , 25849, Singapore
Local Institution - 0170
Singapore , 30843, Singapore
Local Institution - 0141
Manresa Barcelona, 8243, Spain
Local Institution - 0073
Barcelona , 08916, Spain
Local Institution - 0123
Barcelona , 8908, Spain
Local Institution - 0360
Cordoba , 14004, Spain
Local Institution - 0044
Girona , 17007, Spain
Local Institution - 0034
Lugo , 27003, Spain
Local Institution - 0076
Madrid , 28006, Spain
Local Institution - 0024
Madrid , 28033, Spain
Local Institution - 0003
Madrid , 28034, Spain
Local Institution - 0031
Madrid , 28041, Spain
Local Institution - 0364
Madrid , 28222, Spain
Local Institution - 0124
Sabadell (Barcelona) , 08208, Spain
Local Institution - 0363
Sevilla , 41013, Spain
Local Institution - 0192
Niaosng Kaohsiung, 833, Taiwan
Local Institution - 0194
Taichung , 404, Taiwan
Local Institution - 0371
Taichung , 40705, Taiwan
Local Institution - 0386
Tainan , 704, Taiwan
Local Institution - 0175
Taipei , 10002, Taiwan
Local Institution - 0188
Taipei , 11121, Taiwan
Local Institution - 0094
Adana , 01330, Turkey
Local Institution - 0119
Ankara , 06620, Turkey
Local Institution - 0130
Ankara , 6100, Turkey
Local Institution - 0113
Istanbul , 34098, Turkey
Local Institution - 0104
Izmir , 35575, Turkey
Local Institution - 0112
Malatya , 44280, Turkey
Local Institution - 0173
London Greater London, SW3 6, United Kingdom
Local Institution - 0098
Manchester Lancashire, M20 4, United Kingdom
Local Institution - 0008
Northwood Middlesex, HA6 2, United Kingdom
Local Institution - 0051
Nottingham Nottinghamshire, NG5 1, United Kingdom
Local Institution - 0265
Oxford Oxfordshire, OX4 6, United Kingdom
Local Institution - 0048
Guildford Surrey, GU2 7, United Kingdom
Local Institution - 0154
London , NW1 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

984

Study ID:

NCT04100018

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.