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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

    October 18, 2021

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: Biological: Nivolumab
    Drug: Prednisone
    Drug: Docetaxel
    Other: Placebo
  • 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 Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic 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. 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
  • 2. 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 ]
  • 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
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
UCLA Medical Center
Los Angeles

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, 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
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
Cleveland Clinic
Weston

United States, Georgia
Blood Marrow Transplant Group of Georgia at Northside Hospital (Cumming)
Atlanta

United States, Georgia
Local Institution
Marietta

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
Clinton

United States, Massachusetts
Local Institution
Boston

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
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
West Cancer Center
Memphis

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
Spokane

Argentina, Buenos Aires
Hospital Privado de Comunidad
Mar del Plata

Argentina, Cordoba
Local Institution
Rio Cuarto

Argentina, RIO Negro
Clinica Viedma
Viedma

Argentina, Santa FE
Local Institution
Rosario

Argentina
Hospital Britanico de Buenos Aires
Buenos Aires

Argentina
Centro de Investigacion Pergamino SA - Clinica Pergamino
Buenos Aires

Argentina
IDIM-Instituto de Diagnostico e Investigaciones Metabolicas
Buenos Aires

Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires

Argentina
Local Institution
Cordoba

Argentina
Fundacion Richardet Longo FRL
Cordoba

Argentina
Local Institution
La Rioja

Australia, New South Wales
Gosford Hospital
Gosford

Australia, New South Wales
Lismore Base hospital
Lismore

Australia, New South Wales
Adventist HealthCare
Wahroonga

Australia, New South Wales
Westmead Hospital
Westmead

Australia, Queensland
Integrated Clinical Oncology Network Pty Ltd (ICON)
South Brisbane

Australia, Queensland
Princess Alexandra Hospital
Woolloongabba

Australia, South Australia
Adelaide Oncology and Haematology
North Adelaide

Australia, Victoria
Ballarat Base Hospital
Ballarat

Australia, Victoria
Psehog Pty Ltd
Frankston

Australia, Victoria
Cabrini Haematology and Oncology Centre
Malvern

Austria
Krankenhaus der Elisabethinen Linz GmbH
Linz

Austria
Uniklinikum Salzburg Universitatsklinik fur Urologie und Andrologie
Salzburg

Austria
Local Institution
Vienna

Austria
Krankenhaus Barmherzige Brueder Wien
Wien

Austria
Medizinische Universtaet Wien
Wien

Belgium
Hopital Universitaire Erasme
Anderlecht

Belgium
Az Sint-Jan-Campus Sint-Jan
Brugge

Belgium
AZ Sint-Lucas
Gent

Belgium
Universitair Ziekenhuis Gent
Gent

Belgium
Local Institution
Kortrijk

Belgium
Az Turnhout Campus Sint-Elizabeth
Turnhout

Belgium
GZA St. Augustinus
Wilrijk

Brazil, Minas Gerais
Local Institution
Belo Horizonte

Brazil, Minas Gerais
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte

Brazil, Parana
Centro de Pesquisas do IOP
Curitiba

Brazil, Parana
CIONC - Centro Integrado de Oncologia de Curitiba
Curitiba

Brazil, RIO Grande DO Norte
Liga Norte Riograndense Contra o Cancer
Natal

Brazil, RIO Grande DO SUL
Hospital de Caridade de Ijui
Ijui

Brazil, RIO Grande DO SUL
Hospital Moinhos de Vento
Porto Alegre

Brazil, Rio Grande Do Sul
Hospital de Clinicas de Porto Alegre HCPA
Porto Alegre

Brazil, RIO Grande DO SUL
Hospital Mae de Deus
Porto Alegre

Brazil, SAO Paulo
Local Institution
Barretos

Brazil, SAO Paulo
Universidade Estadual De Campinas Unicamp
Campinas

Brazil, SAO Paulo
FMABC - Cepho
Santo Andre

Brazil, SAO Paulo
Hospital de Base de Sao Jose do Rio Preto
Sao Jose do Rio Preto

Brazil, SAO Paulo
Real e Benemrita Associao Portuguesa de Beneficencia Portuguesa de Sao Paulo
So Paulo

Brazil
Centro de Tratamento de Tumores Botafogo - CTTB
Rio de Janeiro

Brazil
Local Institution
Rio de Janeiro

Brazil
Local Institution
Sao Paulo

Brazil
Hospital Alemao Oswaldo Cruz
Sao Paulo

Brazil
Hospital israelita Albert Einstein
Sao Paulo

Canada, Ontario
William Osler Health System
Brampton

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montreal

Canada, Saskatchewan
Local Institution
Saskatoon

Canada
Local Institution
Quebec

Chile, Metropolitana
Local Institution
Santiago de Chile

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Clinica Oncologica IRAM
Santiago

Chile, Metropolitana
Bradford Hill Centro de Investigacion Clinica
Santiago

Chile, Valparaiso
Oncocentro Apys
Vina del Mar

China, Beijing
Local Institution
Beijing Shi

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Chongqing
Local Institution
Chongqing

China, Fujian
Local Institution
Fuzhou

China, Guangdong
Local Institution
Guangzhou

China, Hebei
Local Institution
Baoding Shi

China, Heilongjiang
Local Institution
Harbin

China, Henan
Local Institution
Zhengzhou

China, Henan
Local Institution
Zhengzhou

China, Hubei
Local Institution
Wuhan

China, Hubei
Local Institution
Wuhan

China, Hunan
Local Institution
Changsha

China, Jiangsu
Local Institution
Nanjing

China, Jiangsu
Local Institution
Nanjing

China, Jiangsu
Local Institution
Nanjing

China, Jiangxi
Local Institution
Nanchang Shi

China, Jiangxi
Local Institution
Nanchang

China, Liaoning
Local Institution
Shenyang

China, Shan3xi
Local Institution
Xian Shi

China, Shandong
Local Institution
Jinan

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution
Chengdu

China, Xinjiang
Local Institution
Urumqi

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Hangzhou

Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno

Czechia
Masarykuv onkologicky ustav
Brno

Czechia
Fakultni nemocnice Olomouc
Olomouc

Czechia
University Hospital Ostrava
Ostrava

Czechia
Local Institution
Prague 2

Czechia
Local Institution
Prague 8 - Liben

Czechia
Thomayerova nemocnice
Prague

France
Institut de Cancerologie de l Ouest
Angers Cedex 02

France
Clinique Pasteur - CFRO
Brest

France
Hopital Prive Toulon Hyeres
Hyeres

France
Clinique Victor Hugo
Le Mans

France
Centre Oscar Lambret
Lille

France
Hopital Saint Eloi
Montpellier

France
Centre Hospitalier Universitaire de Nimes Institut de Cancerologie du Gard Oncologie Medicale
Nimes Cedex 9

France
LInstitut Mutualiste Montsouris
Paris

France
Hopital Europeen Georges Pompidou
Paris

France
Hospices Civils de Lyon - Centre hospitalier Lyon Sud
Pierre Benite Cedex

France
ICANS-Institut de cancerologie Strasbourg Europe
Strasbourg

France
Institut Gustave-Roussy
Villejuif Cedex

Germany
Local Institution
Berlin

Germany
Universitaetsklinikum Bonn
Bonn

Germany
Universitaetsklinikum Carl Gustav Carus
Dresden

Germany
Local Institution
Emmendingen

Germany
Universitaetsklinikum Erlangen
Erlangen

Germany
Local Institution
Essen

Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main

Germany
Uni Hamburg-Eppendorf
Hamburg

Germany
Asklepios Klinik Altona
Hamburg

Germany
InVO -Institut fur Versorgungsforschung in der Onkologie GbR
Koblenz

Germany
Local Institution
Koeln

Germany
Local Institution
Luebeck

Germany
Otto-von-Guericke-Universitaet Magdeburg - Universitaetsklinikum Magdeburg A.Oe.
Magdeburg

Germany
Universitaetsklinikum Muenster
Muenster

Germany
Local Institution
Munich

Germany
Local Institution
Nuertingen

Germany
Universitaetsklinikum Tuebingen
Tubingen

Hong Kong
Local Institution
Hong Kong

Hong Kong
Local Institution
Hong Kong

Hong Kong
Local Institution
Hong Kong

Israel
Local Institution
Haifa

Israel
Local Institution
Petach tikva

Israel
Local Institution
Tel Aviv

Israel
Local Institution
Tel Hashomer Ramat Gan

Israel
Local Institution
Zefat

Italy
Guz City Clinical Hospital #57
Benevento

Italy
ASST Papa Giovanni XXIII
Bergamo

Italy
A.O.U. Policlinico Sant Orsola-Malpighi
Bologna

Italy
Asst Spedali Civili Di Brescia
Brescia

Italy
ASST Istituti Ospitalieri
Cremona

Italy
Local Institution
Milano

Italy
Istituto Europeo di Oncologia
Milan

Italy
Local Institution
Modena

Italy
IRCCS Istituto Nazionale dei tumori Fondazione G. Pascale
Napoli

Italy
A.O.U. San Luigi Gonzaga
Orbassano

Italy
Azienda Ospedaliero Universitaria Di Parma
Parma

Italy
Local Institution
Pisa

Italy
Local Institution
Roma

Italy
Local Institution
Terni

Italy
Ospedale Santa Chiara
Trento

Japan, Aichi
Nagoya City University Hospital
Nagoya-shi

Japan, Akita
Akita University Hospital
Akita-Shi

Japan, Aomori
Hirosaki University Hospital
Hirosaki-Shi

Japan, Chiba
Chiba Cancer Center
Chiba-shi

Japan, Chiba
Toho University - Sakura Hospital Medical Center
Sakura Shi

Japan, Ehime
National Hospital Organization Shikoku Cancer Center
Matsuyama-Shi

Japan, Fukuoka
Local Institution
Fukuoka-shi

Japan, Hokkaido
Sapporo Medical University Hospital
Sapporo shi

Japan, Hokkaido
Hokkaido University Hospital
Sapporo-shi

Japan, Kanagawa
Yokohama City University Medical Center
Yokohama

Japan, Kumamoto
Kumamoto Medical Center
Kumamoto Shi

Japan, Kyoto
Kyoto Prefectural University of Medicine
Kyoto-shi

Japan, Nagasaki
Nagasaki University Hospital (NUH)
Nagasaki Shi

Japan, Nara
Nara Medical University Hospital
Kashihara city

Japan, Niigata
Niigata University Medical and Dental Hospital
Niigata shi

Japan, Okayama
Okayama University Hospital
Okayama city

Japan, Osaka
Kindai University Hospital
Osaka Sayama

Japan, Osaka
Osaka International Cancer Institute
Osaka shi

Japan, Osaka
Osaka University Hospital
Suita

Japan, Shizuoka
Hamamatsu University Hospital
Hamamatsu Shi

Japan, Tokyo
Keio University Hospital
Shinjuku-Ku

Japan, Wakayama
Wakayama Medical University Hospital
Wakayama Shi

Japan, Yamaguchi
Yamaguchi University Hospital
Ube shi

Japan
Toyama University Hospital
Toyama

Korea, Republic of
Local Institution
Daejeon

Korea, Republic of
Local Institution
Incheon

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Songnam-si

Korea, Republic of
Local Institution
Yangsan Si

Mexico, Distrito Federal
Local Institution
Ciudad de Mexico

Mexico, Jalisco
Local Institution
Zapopan

Mexico, Michoacan
Local Institution
Morelia

Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Aguascalientes

New Zealand
Local Institution
Hamilton

New Zealand
Local Institution
Palmerston North

New Zealand
Local Institution
Tauranga

Poland
Szpital Wojewodzki im. M. Kopernika w Koszalinie
Koszalin

Poland
WWCOiT Copernicus Memorial Hospital
Lodz

Poland
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
Lublin

Poland
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k.
Poznan

Poland
Local Institution
Warsaw

Poland
Szpital Grochowski im. dr med. Rafala Masztaka Sp. z o.o
Warszawa

Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras

Puerto Rico
Fundacion de Investigacion
San Juan

Romania
Institutul Oncologic Bucuresti IOB
Bucharest

Romania
Prof. Dr. Al.Chiricuta Oncologic Institute Cluj Napoca
Cluj Napoca

Romania
Institutul Oncologic Prof. Dr. I. Chiricuta
Cluj

Romania
Spitalul Clinic Judetean de Urgenta Constanta
Constanta

Romania
Centrul de Oncologie Sf. Nectarie
Craiova

Romania
Oncomed SRL
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
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
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
Singapore

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Spain
ICO Badalona
Barcelona

Spain
Institut Catala D 39 Oncologia Duran I Reynals
Barcelona

Spain
Hospital Universitario Reina Sofia
Cordoba

Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona

Spain
HULA
Lugo

Spain
Hospital Universitario La Princesa
Madrid

Spain
Hospital MD Anderson
Madrid

Spain
Hospital Universitario Ramon y Cajal
Madrid

Spain
Hospital Universitario 12 de Octubre
Madrid

Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid

Spain
Althaia Xarxa Assistencial De Manresa
Manresa

Spain
Corporacio Sanitaria Parc Tauli
Sabadell

Spain
Hospital Universitario Virgen del Rocio
Sevilla

Taiwan
Local Institution
Niaosng

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taipei

Turkey
Cukurova Universitesi Tip Fakultesi
Adana

Turkey
Local Institution
Ankara

Turkey
Hacettepe University Cancer Institute
Ankara

Turkey
Local Institution
Edirne

Turkey
Local Institution
Istanbul

Turkey
Medical Park - Izmir Hastanesi
Izmir

Turkey
Inonu University Turgut Ozal Medical Center
Malatya

United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Guildford

United Kingdom
Local Institution
Lancaster

United Kingdom
Local Institution
Leicester

United Kingdom
Local Institution
London

United Kingdom
UCLH NHS Foundation Trust
London

United Kingdom
Local Institution
London

United Kingdom
The Royal Marsden Nhs Trust
London

United Kingdom
The Christie NHS Foundation Trust
Manchester

United Kingdom
Mount Vernon Hospital
Northwood

United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham

United Kingdom
Local Institution
Oxford

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: October 18, 2021
  • Last Verified: October 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Prostatic Neoplasms