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NCT04100018
Recruiting
September 23, 2019
September 14, 2022
Brief 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.
N/A
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A: Nivolumab + docetaxel + prednisone |
Biological: Nivolumab Specified dose on specified days Drug: Prednisone Specified dose on specified days Drug: Docetaxel Specified dose on specified days |
| Placebo Comparator: Arm B: Placebo + docetaxel + prednisone |
Drug: Prednisone Specified dose on specified days Drug: Docetaxel Specified dose on specified days Other: Placebo Specified dose on specified days |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Alabama
Local Institution - 0305
Mobile
United States, Alaska
Alaska Urological Associates, Apc
Anchorage
United States, Arizona
Local Institution
Phoenix
United States, Arizona
Local Institution
Scottsdale
United States, Arizona
Local Institution
Tucson
United States, Arizona
The University of Arizona Cancer Center
Tucson
United States, Arkansas
St. Bernards Medical Center
Jonesboro
United States, California
University of California, Irvine
Orange
United States, California
Desert Hematology Oncology Medical Group Inc. - Main Office
Rancho Mirage
United States, California
Torrance Health Association DBA Cancer Care Associates
Redondo Beach
United States, California
UCLA Medical Center
Santa Monica
United States, Colorado
The Urology Center of Colorado
Denver
United States, Connecticut
Va Connecticut Healthcare System
West Haven
United States, District of Columbia
Local Institution
Washington
United States, District of Columbia
Medstar Washington Hospital Center
Washington
United States, Florida
Memorial Regional Cancer Center
Hollywood
United States, Florida
Local Institution
Jacksonville
United States, Florida
Lakeland Regional Cancer Center
Lakeland
United States, Florida
Orlando Health Inc., UF Health Cancer Center
Orlando
United States, Florida
Woodlands Medical Specialists, Pa
Pensacola
United States, Florida
Local Institution
Port Saint Lucie
United States, Florida
$Form.Name
Weston
United States, Georgia
Northside Hospital
Atlanta
United States, Georgia
Local Institution
Marietta
United States, Georgia
Lewis Hall Singletary Oncology Center
Thomasville
United States, Illinois
Illinois Cancer Specialists
Niles
United States, Indiana
Ft. Wayne Med Onco-Hema Inc
Fort Wayne
United States, Kansas
Local Institution
Fairway
United States, Kentucky
Norton Cancer Institute
Louisville
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore
United States, Maryland
Maryland Oncology Hematology
Brandywine
United States, Massachusetts
Local Institution
Boston
United States, Mississippi
Local Institution
Jackson
United States, Nebraska
GU Research Network/Urology Cancer Center
Omaha
United States, New Jersey
Regional Cancer Care Associates LLC
East Brunswick
United States, New Jersey
Summit Medical Group
Florham Park
United States, New Jersey
Local Institution
Ridgewood
United States, New York
New York Oncology Hematology, P.C.
Albany
United States, New York
Englander Institute Weill Cornell Medicine
New York
United States, New York
Local Institution
New York
United States, New York
Local Institution
New York
United States, New York
New York Cancer and Blood Specialists
Port Jefferson Station
United States, New York
Local Institution
Poughkeepsie
United States, Ohio
Ohio State University
Columbus
United States, Pennsylvania
Lehigh Valley Health Network
Allentown
United States, Pennsylvania
MidLantic Urology
Bala-Cynwyd
United States, Pennsylvania
Local Institution
Philadelphia
United States, Pennsylvania
University of Pittsburgh Cancer Inst.
Pittsburgh
United States, South Carolina
Charleston Hematology Oncology Associates CHOA
Charleston
United States, South Carolina
Local Institution
Myrtle Beach
United States, Tennessee
The West Cancer Center
Germantown
United States, Texas
Texas Oncology, P.A.
Austin
United States, Texas
Local Institution
Dallas
United States, Texas
Texas Oncology, P.A.
Dallas
United States, Texas
(USOR) Texas Oncology, P.A.
Houston
United States, Texas
University of Texas MD Anderson Cancer Clinic
Houston
United States, Texas
Urology San Antonio P.A.
San Antonio
United States, Texas
The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center
Tyler
United States, Washington
Local Institution
Seattle
United States, Washington
Seattle Cancer Care Alliance
Seattle
United States, Washington
Local Institution - 0289
Spokane
Argentina, Buenos Aires
Local Institution - 0129
Mar del Plata
Argentina, Cordoba
Local Institution - 0393
Rio Cuarto
Argentina, RIO Negro
Local Institution - 0083
Viedma
Argentina, Santa FE
Local Institution
Rosario
Argentina
Local Institution - 0061
Buenos Aires
Argentina
Local Institution - 0185
Buenos Aires
Argentina
Local Institution - 0077
Buenos Aires
Argentina
Local Institution - 0178
Buenos Aires
Argentina
Local Institution - 0390
Cordoba
Argentina
Local Institution - 0153
Cordoba
Argentina
Local Institution - 0369
La Rioja
Argentina
Local Institution
San Juan
Australia, New South Wales
Local Institution - 0152
Gosford
Australia, New South Wales
Lismore Base hospital
Lismore
Australia, New South Wales
Local Institution - 0132
Wahroonga
Australia, New South Wales
Local Institution - 0127
Westmead
Australia, Queensland
Local Institution - 0006
South Brisbane
Australia, Queensland
Local Institution - 0084
Woolloongabba
Australia, South Australia
Local Institution - 0010
North Adelaide
Australia, Victoria
Ballarat Base Hospital
Ballarat
Australia, Victoria
Local Institution - 0040
Frankston
Australia, Victoria
Local Institution - 0032
Malvern
Austria
Local Institution - 0118
Linz
Austria
Local Institution - 0038
Salzburg
Austria
Local Institution
Vienna
Austria
Local Institution - 0157
Wien
Austria
Local Institution - 0131
Wien
Belgium, Brussel
Local Institution - 0122
Anderlecht
Belgium
Local Institution - 0121
Brugge
Belgium
Local Institution - 0114
Gent
Belgium
Local Institution - 0162
Gent
Belgium
Local Institution
Kortrijk
Belgium
Local Institution - 0137
Turnhout
Belgium
Local Institution - 0029
Wilrijk
Brazil, Minas Gerais
Local Institution - 0097
Belo Horizonte
Brazil, Minas Gerais
Local Institution - 0022
Belo Horizonte
Brazil, Parana
Local Institution - 0082
Curitiba
Brazil, Parana
Centro de Pesquisas do IOP
Curitiba
Brazil, RIO Grande DO Norte
Local Institution - 0321
Natal
Brazil, Rio Grande Do Sul
Local Institution - 0058
Ijui
Brazil, RIO Grande DO SUL
Local Institution - 0063
Porto Alegre
Brazil, Rio Grande Do Sul
Local Institution - 0056
Porto Alegre
Brazil, RIO Grande DO SUL
Local Institution - 0057
Porto Alegre
Brazil, SAO Paulo
Local Institution
Barretos
Brazil, SAO Paulo
Local Institution - 0086
Campinas
Brazil, SAO Paulo
Local Institution - 0096
Sao Jose Do Rio Preto
Brazil, SAO Paulo
Local Institution - 0080
So Paulo
Brazil, SP
Local Institution - 0059
Santo Andre
Brazil
Local Institution - 0189
Rio de Janeiro
Brazil
Local Institution - 0060
Rio de Janeiro
Brazil
Local Institution
Sao Paulo
Brazil
Local Institution - 0273
Sao Paulo
Brazil
Local Institution - 0328
Sao Paulo
Canada, Ontario
Local Institution - 0151
Brampton
Canada, Ontario
North York General Hospital
Toronto
Canada, Quebec
Local Institution
Montreal
Canada, Saskatchewan
Local Institution
Saskatoon
Canada
Local Institution
Quebec
Chile, Metropolitana
Local Institution - 0378
Santiago
Chile, Metropolitana
Local Institution - 0377
Santiago
Chile, Metropolitana
Local Institution - 0026
Santiago
Chile, Metropolitana
Local Institution - 0025
Santiago
Chile, Valparaiso
Local Institution - 0027
Vina del Mar
China, Beijing
Local Institution
Beijing Shi
China, Beijing
Local Institution
Beijing
China, Beijing
Local Institution - 0254
Beijing
China, Beijing
Local Institution - 0312
Beijing
China, Beijing
Local Institution
Beijing
China, Beijing
Local Institution - 0245
Beijing
China, Beijing
Local Institution - 0345
Beijing
China, Chongqing
Local Institution
Chongqing
China, Fujian
Local Institution - 0256
Fuzhou
China, Guangdong
Local Institution - 0319
Guangzhou
China, Hebei
Local Institution
Baoding Shi
China, Heilongjiang
Local Institution - 0224
Harbin
China, Henan
Local Institution - 0314
Zhengzhou
China, Henan
Local Institution - 0275
Zhengzhou
China, Hubei
Local Institution
Wuhan
China, Hubei
Local Institution - 0313
Wuhan
China, Hunan
Local Institution - 0168
Changsha
China, Jiangsu
Local Institution - 0165
Nanjing
China, Jiangsu
Local Institution - 0317
Nanjing
China, Jiangsu
Local Institution - 0325
Nanjing
China, Jiangxi
Local Institution - 0347
Nanchang Shi
China, Jiangxi
Local Institution
Nanchang
China, Liaoning
Local Institution - 0161
Shenyang
China, Shan1xi
Local Institution
Xi'an
China, Shandong
Local Institution
Jinan
China, Shanghai
Local Institution - 0155
Shanghai
China, Shanghai
Local Institution
Shanghai
China, Sichuan
Local Institution - 0253
Chengdu
China, Xinjiang
Local Institution - 0310
Urumqi
China, Zhejiang
Local Institution
Hangzhou
China, Zhejiang
Local Institution - 0344
Hangzhou
Czechia
Local Institution - 0093
Brno
Czechia
Local Institution - 0108
Brno
Czechia
Local Institution - 0049
Olomouc
Czechia
Local Institution - 0349
Ostrava
Czechia
Local Institution - 0088
Ostrava
Czechia
Local Institution
Prague 2
Czechia
Local Institution - 0050
Prague
Czechia
Local Institution - 0361
Prague
France, Nord
Local Institution - 0079
Lille
France, Sarthe
Local Institution - 0167
Le Mans
France
Local Institution - 0107
Angers Cedex 02
France
Local Institution - 0202
Brest
France
Local Institution - 0398
Dijon
France
Hopital Prive Toulon Hyeres
Hyeres
France
Local Institution - 0395
Montpellier
France
Local Institution - 0109
Montpellier
France
Local Institution - 0384
Nice cedex 2
France
Local Institution - 0068
Nimes Cedex 9
France
Local Institution - 0381
Paris
France
Local Institution - 0106
Paris
France
Local Institution - 0071
Paris
France
Local Institution - 0133
Pierre-Benite
France
Local Institution - 0399
Reims
France
Local Institution - 0380
Rennes Cedes
France
Local Institution - 0387
Strasbourg
France
Local Institution - 0105
Strasbourg
France
Local Institution - 0271
Villejuif Cedex
Germany, Rheinland Pfa
Local Institution - 0014
Koblenz
Germany
Local Institution
Berlin
Germany
Local Institution - 0089
Bonn
Germany
Local Institution - 0090
Dresden
Germany
Local Institution - 0376
Duesseldorf
Germany
Local Institution
Emmendingen
Germany
Local Institution - 0142
Erlangen
Germany
Local Institution
Essen
Germany
Local Institution - 0018
Frankfurt am Main
Germany
Local Institution - 0064
Hamburg
Germany
Asklepios Klinik Altona
Hamburg
Germany
Local Institution - 0389
Heidelberg
Germany
Local Institution
Koeln
Germany
Local Institution
Luebeck
Germany
Local Institution - 0004
Magdeburg
Germany
Local Institution - 0372
Marburg
Germany
Local Institution - 0036
Muenster
Germany
Local Institution - 0204
München
Germany
Local Institution - 0023
Nuertingen
Germany
Local Institution - 0169
Tuebingen
Hong Kong
Local Institution - 0146
Hong Kong
Hong Kong
Local Institution
Hong Kong
Hong Kong
Local Institution
Hong Kong
Israel
Local Institution - 0072
Haifa
Israel
Local Institution - 0388
Jerusalem
Israel
Local Institution - 0368
Kfar Saba
Israel
Local Institution - 0128
Petach tikva
Israel
Local Institution - 0135
Ramat Gan
Israel
Local Institution - 0138
Tel Aviv
Israel
Local Institution
Zefat
Italy
Local Institution - 0099
Benevento
Italy
Local Institution - 0001
Bergamo
Italy
A.O.U. Policlinico Sant Orsola-Malpighi
Bologna
Italy
Local Institution - 0039
Brescia
Italy
ASST Istituti Ospitalieri
Cremona
Italy
Local Institution - 0230
Milano
Italy
Local Institution - 0066
Milano
Italy
Local Institution
Modena
Italy
Local Institution - 0120
Napoli
Italy
Local Institution - 0070
Orbassano
Italy
Local Institution - 0037
Parma
Italy
Local Institution - 0199
Pisa
Italy
Local Institution - 0046
Roma
Italy
Local Institution - 0385
Rome
Italy
Local Institution - 0228
Terni
Italy
Local Institution - 0067
Trento
Japan, Aichi
Local Institution - 0362
Nagoya
Japan, Akita
Local Institution - 0340
Akita-shi
Japan, Aomori
Local Institution - 0358
Hirosaki-shi
Japan, Chiba
Local Institution - 0346
Chiba-shi
Japan, Chiba
Local Institution - 0339
Sakura Shi
Japan, Ehime
Local Institution - 0307
Matsuyama-Shi
Japan, Fukuoka
Local Institution
Fukuoka-shi
Japan, Hokkaido
Local Institution - 0281
Sapporo shi
Japan, Hokkaido
Local Institution - 0296
Sapporo-shi
Japan, Kanagawa
Local Institution - 0283
Yokohama-shi
Japan, Kumamoto
Local Institution - 0324
Kumamoto Shi
Japan, Kyoto
Local Institution - 0342
Kamigyo-ku
Japan, Nagasaki
Local Institution - 0341
Nagasaki Shi
Japan, Nara
Local Institution - 0355
Kashihara city
Japan, Niigata
Local Institution - 0327
Niigata shi
Japan, Okayama
Local Institution - 0354
Okayama-city
Japan, Osaka
Local Institution - 0323
Osaka Sayama
Japan, Osaka
Local Institution - 0343
Osaka-shi
Japan, Osaka
Local Institution - 0338
Suita
Japan, Shizuoka
Local Institution - 0309
Hamamatsu Shi
Japan, Tokyo
Local Institution - 0308
Shinjuku-Ku
Japan, Wakayama
Local Institution - 0278
Wakayama Shi
Japan, Yamaguchi
Yamaguchi University Hospital
Ube shi
Japan
Local Institution - 0279
Toyama
Korea, Republic of, Daejeon
Local Institution - 0297
Jung-gu
Korea, Republic of, Gyeonggi-do
Local Institution - 0186
Songnam-si
Korea, Republic of
Local Institution - 0391
Daegu
Korea, Republic of
Local Institution - 0298
Incheon
Korea, Republic of
Local Institution - 0375
Jeollanam-do
Korea, Republic of
Local Institution - 0374
Seodaemun-Gu
Korea, Republic of
Local Institution - 0370
Seoul
Korea, Republic of
Local Institution - 0171
Seoul
Korea, Republic of
Local Institution - 0193
Seoul
Korea, Republic of
Local Institution - 0187
Seoul
Korea, Republic of
Local Institution - 0373
Seoul
Korea, Republic of
Local Institution - 0158
Yangsan Si
Mexico, Distrito Federal
Local Institution
Ciudad de Mexico
Mexico, Jalisco
Local Institution - 0016
Zapopan
Mexico, Michoacan
Local Institution
Morelia
Mexico
Local Institution - 0015
Aguascalientes
New Zealand
Local Institution - 0101
Hamilton
New Zealand
Local Institution - 0184
Palmerston North
New Zealand
Local Institution
Tauranga
Poland
Local Institution - 0383
Bydgoszcz
Poland
Local Institution - 0136
Koszalin
Poland
Local Institution - 0009
Lodz
Poland
Local Institution - 0013
Lublin
Poland
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k.
Poznan
Poland
Local Institution
Warsaw
Poland
Local Institution - 0095
Warszawa
Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras
Puerto Rico
Fundacion De Investigacion
San Juan
Romania, Cluj-Napoca
Local Institution - 0041
Cluj
Romania
Local Institution - 0042
Bucharest
Romania
Local Institution - 0043
Cluj Napoca
Romania
Local Institution - 0020
Constanta
Romania
Local Institution - 0052
Craiova
Romania
Local Institution - 0035
Timisoara
Russian Federation
SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk
Russian Federation
Local Institution
Ivanovo
Russian Federation
SAHI Republican Clinical Oncology Dispensary of MoH of RT
Kazan
Russian Federation
Clinical Hospital MEDSI in Otradnoye
Krasnogorsk Moscow Region
Russian Federation
Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the
Moscow
Russian Federation
Local Institution
Moscow
Russian Federation
Sechenov University
Moscow
Russian Federation
Local Institution
Moscow
Russian Federation
P.A. Herzen Moscow Oncology Research Institute
Moscow
Russian Federation
FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre
Obninsk
Russian Federation
Budgetary Healthcare Institution of Omsk Region ",Clinical Oncological Dispensary",
Omsk
Russian Federation
Local Institution
Ryazan
Russian Federation
Andros Clinic LLC
Saint-Petersburg
Russian Federation
Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A.
Saint-Petersburg
Singapore
Local Institution - 0116
Singapore
Singapore
Local Institution
Singapore
Singapore
Local Institution
Singapore
Singapore
Local Institution - 0170
Singapore
Spain, Barcelona
Local Institution - 0141
Manresa
Spain, Barcelona
Local Institution - 0124
Sabadell
Spain
Local Institution - 0073
Barcelona
Spain
Institut Catala D 39 Oncologia Duran I Reynals
Barcelona
Spain
Local Institution - 0360
Cordoba
Spain
Local Institution - 0044
Girona
Spain
Local Institution - 0034
Lugo
Spain
Local Institution - 0076
Madrid
Spain
Local Institution - 0024
Madrid
Spain
Local Institution - 0003
Madrid
Spain
Local Institution - 0031
Madrid
Spain
Local Institution - 0364
Madrid
Spain
Local Institution - 0363
Sevilla
Taiwan, Kaohsiung
Local Institution - 0192
Niaosng
Taiwan
Local Institution - 0194
Taichung
Taiwan
Local Institution - 0371
Taichung
Taiwan
Local Institution
Tainan
Taiwan
Local Institution - 0175
Taipei
Taiwan
Local Institution - 0188
Taipei
Turkey
Local Institution - 0094
Adana
Turkey
Local Institution - 0119
Ankara
Turkey
Local Institution - 0130
Ankara
Turkey
Local Institution
Edirne
Turkey
Local Institution
Istanbul
Turkey
Local Institution - 0104
Izmir
Turkey
Local Institution - 0112
Malatya
United Kingdom, Greater London
Local Institution - 0173
London
United Kingdom, Lancashire
Local Institution - 0098
Manchester
United Kingdom, Leicestershire
Local Institution - 0264
Leicester
United Kingdom, Middlesex
Local Institution - 0008
Northwood
United Kingdom, Nottinghamshire
Local Institution - 0051
Nottingham
United Kingdom, Oxfordshire
Local Institution - 0265
Oxford
United Kingdom
Local Institution - 0048
Guildford
United Kingdom
Local Institution
Lancaster
United Kingdom
Local Institution
London
United Kingdom
Local Institution - 0154
London
United Kingdom
Local Institution
London
United Kingdom
Local Institution
Preston
United Kingdom
Local Institution
Southampton
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb