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

  • Clinicaltrials.gov identifier

    NCT04100018

  • Recruitment Status

    Recruiting

  • First Posted

    September 23, 2019

  • Last update posted

    September 14, 2022

Study Description

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.

  • Condition or Disease:Prostate Cancer
  • Intervention/Treatment: Drug: Docetaxel
    Other: Placebo
    Biological: Nivolumab
    Drug: Prednisone
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 984 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
  • Actual Study Start Date: February 2020
  • Estimated Primary Completion Date: April 2023
  • Estimated Study Completion Date: August 2027

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death from any cause, approximately 38 months. For participants who are alive, their survival time will be censored at the last date that they were known to be alive ]
  • 2. Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: From the date of randomization to the first date of documented progression or death due to any cause, whichever occurs first, approximately 25 months ]
    Up to 433 rPFS events
  • Secondary Outcome Measures: 1. Objective Response Rate (ORR) per PCWG3 [ Time Frame: From the date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first, approximately 25 months ]
  • 2. Time to Response per PCWG3 (TTR-PCWG3) determined by BICR [ Time Frame: From the date of randomization to the date of the first documented complete response (CR) or partial response (PR), approximately 25 months ]
  • 3. Duration of Response (DOR) per PCWG3 determined by BICR [ Time Frame: From the date of first response (CR/PR) to the date of first documented radiographic progression, or death due to any cause, approximately 25 months ]
  • 4. Prostate-specific antigen (PSA) Response Rate (PSA-RR) [ Time Frame: Approximately 25 months ]
  • 5. Time to PSA Progression (TTP-PSA) [ Time Frame: From date of randomization to the date of PSA progression per PCWG3, approximately 25 months ]
  • 6. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 25 months ]
  • 7. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 25 months ]
  • 8. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 25 months ]
  • 9. Incidence of immune-mediated AEs [ Time Frame: Approximately 25 months ]
  • 10. Incidence of deaths [ Time Frame: Approximately 25 months ]
  • 11. Incidence of laboratory abnormalities: Clinical Chemistry Tests [ Time Frame: Approximately 25 months ]
  • 12. Incidence of laboratory abnormalities: Hematology tests [ Time Frame: Approximately 25 months ]
  • 13. Incidence of laboratory abnormalities: Serology tests [ Time Frame: Approximately 25 months ]
  • 14. Median time to pain progression assessed by Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Approximately 25 months ]
  • 15. Incidence of changes from baseline in Physical Exam [ Time Frame: Approximately 25 months ]
  • 16. Incidence of changes from baseline in vital signs: Respiratory rate [ Time Frame: Approximately 25 months ]
  • 17. Incidence of changes from baseline in vital signs: Body temperature [ Time Frame: Approximately 25 months ]
  • 18. Incidence of changes from baseline in vital signs: Blood pressure [ Time Frame: Approximately 25 months ]
  • 19. Incidence of changes from baseline in vital signs: Heart Rate [ Time Frame: Approximately 25 months ]
  • 20. Incidence of changes from baseline electrocardiogram (ECG) [ Time Frame: Approximately 25 months ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

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 #.

Locations

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 &quot,Clinical Oncological Dispensary&quot,
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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04100018 History of Changes
  • Other Study ID Numbers: CA209-7DX, 2019-002030-36
  • First Posted: September 23, 2019 Key Record Dates
  • Last Update Posted: September 14, 2022
  • Last Verified: September 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Prostatic Neoplasms
    Genital Neoplasms, Male
    Urogenital Neoplasms
    Neoplasms by Site
    Neoplasms
    Prostatic Diseases