A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)
Status: Recruiting
Location: See all (236) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment. The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
• Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
• Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
• Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
Locations
United States
Alabama
Urology Centers of Alabama
RECRUITING
Homewood
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
Ironwood Cancer & Research Centers
RECRUITING
Gilbert
Ironwood Cancer & Research Centers
RECRUITING
Glendale
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Phoenix
Ironwood Cancer & Research Centers
RECRUITING
Scottsdale
Arizona Urology Specialists (AUS)-Orange Grove
RECRUITING
Tucson
California
Los Angeles Cancer Network
RECRUITING
Anaheim
UCSF Cancer Center Berkeley
RECRUITING
Berkeley
UCSF Cancer Center Burlingame
RECRUITING
Burlingame
Los Angeles Cancer Network
RECRUITING
Fountain Valley
Los Angeles Cancer Network
RECRUITING
Glendale
Los Angeles Cancer Network
RECRUITING
Glendale
Los Angeles Cancer Network
RECRUITING
Los Angeles
Los Angeles Cancer Network
RECRUITING
Los Angeles
Stanford Cancer Center
RECRUITING
Palo Alto
UCSF Investigational Drug Pharmacy
RECRUITING
San Francisco
UCSF Medical Center at Mission Bay
RECRUITING
San Francisco
UCSF Cancer Center San Mateo
RECRUITING
San Mateo
Sutter Santa Rosa
RECRUITING
Santa Rosa
Stanford Health Care Attention: Investigational Pharmacy
RECRUITING
Stanford
Colorado
Colorado Clinical Research
RECRUITING
Lakewood
Florida
University of Miami Sylvester Comprehensive Cancer Center - Aventura
RECRUITING
Aventura
Florida Cancer Specialists
RECRUITING
Bonita Springs
Florida Cancer Specialists
RECRUITING
Bradenton
Florida Cancer Specialists
RECRUITING
Cape Coral
University of Miami Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
RECRUITING
Coral Gables
University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach
RECRUITING
Deerfield Beach
University of Miami Hospital and Clinics - Doral
RECRUITING
Doral
Florida Cancer Specialists
RECRUITING
Fort Myers
Florida Cancer Specialists
RECRUITING
Fort Myers
University of Miami Sylvester Comprehensive Cancer Center - Kendall
RECRUITING
Kendall
University of Miami Hospital and Clinics, Sylvester Cancer Center
RECRUITING
Miami
University of Miami Hospital and Clinics, UHealth Tower
RECRUITING
Miami
University of Miami Sylvester Comprehensive Cancer Center - Griffin Cancer Research Building
RECRUITING
Miami
Florida Cancer Specialists
RECRUITING
N. Venice
Florida Cancer Specialists
RECRUITING
Naples
AdventHealth Hematology and Oncology
RECRUITING
Orlando
AdventHealth Orlando Infusion Center
RECRUITING
Orlando
University of Miami Sylvester Comprehensive Cancer Center - Plantation
RECRUITING
Plantation
Florida Cancer Specialists
RECRUITING
Port Charlotte
Florida Cancer Specialists
RECRUITING
Sarasota
Illinois
Duly Health and Care
RECRUITING
Hinsdale
Duly Health And Care
RECRUITING
Lisle
NextStage Clinical Research-Chicago-(04)
RECRUITING
Lisle
Duly Health and Care
RECRUITING
Westmont
Kentucky
The University of Louisville, James Graham Brown Cancer Center
RECRUITING
Louisville
University of Louisville Hospital
RECRUITING
Louisville
UofL Health Medical Center Northeast
RECRUITING
Louisville
Maine
New England Cancer Specialists
RECRUITING
Topsham
New England Cancer Specialists
RECRUITING
Westbrook
Missouri
VA St. Louis Health Care System
RECRUITING
St Louis
North Carolina
Salisbury VA Medical Center
RECRUITING
Salisbury
New Jersey
AtlantiCare
RECRUITING
Egg Harbor
New York
Circuit Clinical
RECRUITING
Middletown
Circuit Clinical /Crystal Run Healthcare LLP
RECRUITING
Middletown
Crystal Run Healthcare
RECRUITING
Monroe
James J. Peters VA Medical Center
RECRUITING
The Bronx
Pennsylvania
The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists
RECRUITING
Lancaster
South Carolina
AUC Urologists, LLC
RECRUITING
Myrtle Beach
Carolina Urologic Research Center, LLC
RECRUITING
Myrtle Beach
Grand Strand Medical Center
RECRUITING
Myrtle Beach
Parkway Surgery Center
RECRUITING
Myrtle Beach
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Houston Methodist Baytown Hospital
NOT_YET_RECRUITING
Baytown
Houston Methodist Cypress Hospital
NOT_YET_RECRUITING
Cypress
Houston Methodist Clear Lake Hospital
NOT_YET_RECRUITING
Houston
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
Houston Methodist Hospital Infusion
NOT_YET_RECRUITING
Houston
Houston Methodist West Hospital
NOT_YET_RECRUITING
Houston
Houston Methodist Willowbrook Hospital
NOT_YET_RECRUITING
Houston
USA Clinical Trials
RECRUITING
San Antonio
Houston Methodist Sugar Land Hospital
NOT_YET_RECRUITING
Sugar Land
Houston Methodist The Woodlands Hospital
NOT_YET_RECRUITING
The Woodlands
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Harborview Medical Center
RECRUITING
Seattle
University of Washington Medical Center - Montlake
RECRUITING
Seattle
Other Locations
Argentina
Asociación de Beneficencia Hospital Sirio Libanés
RECRUITING
Buenos Aires
Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC)
RECRUITING
Buenos Aires
IMAXE
RECRUITING
Buenos Aires
Centro de Urología (CDU)
RECRUITING
Caba
Centro Medico Privado CEMAIC
RECRUITING
Capital
Hospital Sirio Libanes
RECRUITING
Capital Federal
Instituto Alexander Fleming
RECRUITING
Ciudad Autónoma De Buenos Aires
Imagenes Mdq
RECRUITING
Mar Del Plata
Instituto de Investigaciones Clínicas Mar del Plata
RECRUITING
Mar Del Plata
Australia
Icon Cancer Centre Wesley
RECRUITING
Auchenflower
Monash Health
RECRUITING
Clayton
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Brazil
Crio - Centro Regional Integrado de Oncologia
RECRUITING
Fortaleza
Hospital São Carlos
RECRUITING
Fortaleza
Hospital São Lucas da PUCRS
RECRUITING
Porto Alegre
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
RECRUITING
Santo André
Fundação Faculdade Regional de Medicina de São José do Rio Preto
RECRUITING
São José Do Rio Preto
Hospital de Base de São José do Rio Preto
RECRUITING
São José Do Rio Preto
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
IBCC - Núcleo de Pesquisa e Ensino
RECRUITING
São Paulo
Instituto do Cancer Arnaldo Vieira de Carvalho
RECRUITING
São Paulo
Canada
Arthur J.E. Child Comprehensive Cancer Centre
RECRUITING
Calgary
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Sunnybrook Research Institute
RECRUITING
Toronto
BC Cancer Vancouver
RECRUITING
Vancouver
China
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Fujian Cancer Hospital
RECRUITING
Fuzhou
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Guangzhou First People's Hospital
RECRUITING
Guangzhou
Southern Medical University Nanfang Hospital
RECRUITING
Guangzhou
The Second Affiliated Hospital of Guilin Medical University
RECRUITING
Guilin
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Huai'an First People's Hospital
RECRUITING
Huai'an
The First Hospital of Jiaxing
RECRUITING
Jiaxing
Lanzhou university second hospital
RECRUITING
Lanzhou
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Nantong Tumor Hospital
RECRUITING
Nantong
The first affiliated hospital of Ningbo university
RECRUITING
Ningbo
Tongji Hospital of Tongji University
RECRUITING
Shanghai
The First Hospital of China Medical University
RECRUITING
Shenyang
The First Hospital of China Medical University
RECRUITING
Shenyang
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Wannan Medical College Yijishan Hospital
RECRUITING
Wuhu
Shaanxi Provincial People' Hospital
RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Yantai Yuhuangding Hospital
RECRUITING
Yantai
France
CHRU de Brest
RECRUITING
Brest
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
RECRUITING
Clermont-ferrand
Centre Leon Berard
RECRUITING
Lyon Cedex08
Centre Antoine Lacassagne
RECRUITING
Nice
Centre Antoine-Lacassagne
RECRUITING
Nice
Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire
RECRUITING
Nîmes
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Institut Jean Godinot
RECRUITING
Reims
Centre Hospitalier Privé Saint-Grégoire
RECRUITING
Saint-grégoire
Institut de cancérologie Strasbourg Europe (ICANS)
RECRUITING
Strasbourg
Hôpital Foch
RECRUITING
Suresnes
Oncopole Claudius Regaud
RECRUITING
Toulouse
Gustave Roussy
RECRUITING
Villejuif
Germany
Universitaetsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Urologie Neandertal - Praxis Mettmann
RECRUITING
Mettmann
Universitätsklinikum Münster - Albert Schweitzer Campus
RECRUITING
Münster
Studienpraxis Urologie
RECRUITING
Nürtingen
Universitaetsklinikum Tuebingen
RECRUITING
Tübingen
Greece
Alexandra General Hospital of Athens
RECRUITING
Athens
Athens Medical Center
RECRUITING
Athens
Metropolitan General Hospital
RECRUITING
Athens
University General Hospital ATTIKON - General Hospital of West Attica H AGIA VARVARA
RECRUITING
Chaïdári
Hungary
Országos Onkológiai Intézet
RECRUITING
Budapest
Petz Aladar Egyetemi Oktato Korhaz
RECRUITING
Győr
Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
RECRUITING
Meldola
Ospedale San Raffaele
RECRUITING
Milan
Istituto Nazionale Tumori Regina Elena
RECRUITING
Rome
Japan
Chiba cancer center
RECRUITING
Chiba
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Kanazawa University Hospital
RECRUITING
Kanazawa
National Cancer Center Hospital East
RECRUITING
Kashiwa
Kobe University Hospital
RECRUITING
Kobe
National Hospital Organization Kumamoto Medical Center
RECRUITING
Kumamoto
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
Osaka International Cancer Institute
RECRUITING
Osaka
Hokkaido University Hospital
RECRUITING
Sapporo
National Hospital Organization Hokkaido Cancer Center
RECRUITING
Sapporo
Keio university hospital
RECRUITING
Shinjuku-ku
The University of Osaka Hospital
RECRUITING
Suita
Yamagata University Hospital
RECRUITING
Yamagata
Yokohama City University Medical Center
RECRUITING
Yokohama
Yokosuka Kyosai Hospital
RECRUITING
Yokosuka
Netherlands
Meander Medisch Centrum
RECRUITING
Amersfoort
Tergooi MC
RECRUITING
Hilversum
Frisius Medisch Centrum
RECRUITING
Leeuwarden
Canisius-Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Poland
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego
RECRUITING
Grudziądz
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie
RECRUITING
Koszalin
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
RECRUITING
Krakow
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
RECRUITING
Krakow
MICS Centrum Medyczne Torun
RECRUITING
Torun
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
RECRUITING
Wroclaw
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
National Cancer Center
RECRUITING
Goyang-si
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Asan Medical Center
RECRUITING
Seoul
Ewha Womans University Mokdong Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Slovakia
Narodny onkologicky ustav
RECRUITING
Bratislava
Vychodoslovensky onkologicky ustav, a.s.
RECRUITING
Košice
Univerzitna nemocnica Martin, Onkologicka ambulancia
RECRUITING
Martin
BEKY - MED, s.r.o.
RECRUITING
Prešov
MILAB, s.r.o., Urologicka ambulancia
RECRUITING
Prešov
Fakultna nemocnica Trnava
RECRUITING
Trnava
South Africa
TASK Eden
RECRUITING
George
Wits Clinical Research
RECRUITING
Johannesburg
Cancercare Langenhoven Drive Oncology Centre
RECRUITING
Port Elizabeth
Wilgers Oncology Centre
RECRUITING
Pretoria
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet
RECRUITING
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Althaia, Xarxa Assistencial Universitària de Manresa
RECRUITING
Manresa
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Södersjukhuset
RECRUITING
Stockholm
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
Turkey
Adana City Hospital
RECRUITING
Adana
Ankara University Health Practice and Research Hospitals
RECRUITING
Ankara
Gazi University Health Research and Application Center Gazi Hospital
RECRUITING
Ankara
Gulhane Egitim Arastirma Hastanesi
RECRUITING
Ankara
Memorial Ankara Hastanesi
RECRUITING
Ankara
Istanbul Universitesi Cerrahpasa
RECRUITING
Istanbul
Koç Üniversitesi Hastanesi
RECRUITING
Istanbul
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
RECRUITING
Istanbul
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
RECRUITING
Istanbul
I.E.U. Medical Point Hastanesi
RECRUITING
Izmir
United Kingdom
Royal Blackburn Hospital
RECRUITING
Blackburn
Western General Hospital
RECRUITING
Edinburgh
The Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
University College London Hospital
RECRUITING
London
The Clatterbridge Cancer Centre
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
Singleton Hospital
RECRUITING
Swansea
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2028-10-29
Participants
Target number of participants: 600
Treatments
Experimental: Arm A
Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)
Active_comparator: Arm B
Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days
Related Therapeutic Areas
Sponsors
Leads: Pfizer