A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)
Status: Recruiting
Location: See all (247) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
• Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
• Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease).
• Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).
• Participants must have ECOG PS 0 or 1.
Locations
United States
Alabama
Clearview Cancer Institute
NOT_YET_RECRUITING
Huntsville
Clearview Cancer Institute (Crestwood)
NOT_YET_RECRUITING
Huntsville
Arkansas
Highlands Oncology Group, PA
RECRUITING
Fayetteville
Highlands Oncology Group, PA
RECRUITING
Rogers
Highlands Oncology Group, PA
RECRUITING
Springdale
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
Ironwood Cancer & Research Centers
RECRUITING
Gilbert
Ironwood Cancer & Research Centers
RECRUITING
Glendale
Ironwood Cancer & Research Centers
RECRUITING
Goodyear
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Phoenix
Ironwood Cancer & Research Centers
RECRUITING
Scottsdale
California
UCLA Hematology/Oncology - Alhambra
RECRUITING
Alhambra
UCLA Hematology/Oncology - Atascadero
RECRUITING
Atascadero
Cedars-Sinai Cancer Beverly Hills
NOT_YET_RECRUITING
Beverly Hills
Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location)
NOT_YET_RECRUITING
Beverly Hills
UCLA Hematology/Oncology - Beverly Hills
RECRUITING
Beverly Hills
UCLA Hematology/Oncology - Burbank
RECRUITING
Burbank
UCLA Hematology/Oncology - Encino
RECRUITING
Encino
UCLA Hematology/Oncology - Irvine
RECRUITING
Irvine
UCLA Hematology/Oncology - Laguna Hills
RECRUITING
Laguna Hills
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
NOT_YET_RECRUITING
Los Angeles
Ronald Reagan UCLA Medical Center - Drug Information Center
RECRUITING
Los Angeles
UCLA Department of Medicine - Hematology/Oncology
RECRUITING
Los Angeles
UCLA Hematology/Oncology
RECRUITING
Los Angeles
UCLA Hematology/Oncology - Marina del Rey
RECRUITING
Marina Del Rey
UCLA Hematology/Oncology - Pasadena
RECRUITING
Pasadena
UCLA Hematology/Oncology - Porter Ranch
RECRUITING
Porter Ranch
UCLA Hematology/Oncology - San Luis Obispo
RECRUITING
San Luis Obispo
UCLA Hematology/Oncology - Santa Barbara
RECRUITING
Santa Barbara
UCLA Hematology/Oncology- Santa Monica
RECRUITING
Santa Monica
UCLA Hematology/Oncology - Torrance
RECRUITING
Torrance
UCLA Hematology/Oncology - Santa Clarita
RECRUITING
Valencia
UCLA Hematology/Oncology - Ventura
RECRUITING
Ventura
UCLA Hematology/Oncology - Westlake
RECRUITING
Westlake Village
Colorado
AdventHealth Medical Group Urology of Denver
NOT_YET_RECRUITING
Denver
Illinois
Cancer Care Specialists of Illinois
RECRUITING
Decatur
Cancer Care Specialists of Illinois
RECRUITING
O'fallon
North Carolina
Duke Cancer Center Cary
NOT_YET_RECRUITING
Cary
Duke University
NOT_YET_RECRUITING
Durham
Duke University Medical Center - Duke Cancer Center
NOT_YET_RECRUITING
Durham
Duke University Medical Center - Duke University Hospital (location of scans)
NOT_YET_RECRUITING
Durham
Duke University Medical Center (location of scans)
NOT_YET_RECRUITING
Durham
Duke Cancer Center Raleigh
NOT_YET_RECRUITING
Raleigh
Duke Raleigh Hospital
NOT_YET_RECRUITING
Raleigh
Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)
NOT_YET_RECRUITING
Raleigh
New York
University of Rochester Medical Center
NOT_YET_RECRUITING
Rochester
University of Rochester, Cancer Center Pharmacy (Investigational Product)
NOT_YET_RECRUITING
Rochester
Montefiore Einstein Comprehensive Cancer Center
RECRUITING
The Bronx
Montefiore Medical Center- Montefiore Medical Park
RECRUITING
The Bronx
Ohio
University Hospitals Seidman Cancer Center at UH Avon Health Center
RECRUITING
Avon
TriState Urologic Services PSC Inc. dba The Urology Group
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
University Hospitals Seidman Cancer Center at UH Mentor Health Center
RECRUITING
Mentor
UH Minoff Health Center at Chagrin Highlands
RECRUITING
Orange
Pennsylvania
The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists
RECRUITING
Lancaster
South Carolina
Carolina Urologic Research Center, LLC
RECRUITING
Myrtle Beach
Grand Strand Medical Center
RECRUITING
Myrtle Beach
Parkway Surgery Center
RECRUITING
Myrtle Beach
Tennessee
The West Clinic, PLLC dba West Cancer Center
NOT_YET_RECRUITING
Germantown
Urology Associates, P.C.
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
University of Texas Southwestern Medical Center - Simmons Cancer Center
RECRUITING
Dallas
University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
RECRUITING
Dallas
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
RECRUITING
Dallas
University of Texas Southwestern Simmons Cancer Center - Redbird
RECRUITING
Dallas
University of Texas Southwestern Simmons Cancer Center - Fort Worth
RECRUITING
Fort Worth
US Oncology Investigational Product Center (IPC)
RECRUITING
Irving
University of Texas Southwestern Simmons Cancer Center - Richardson/Plano
RECRUITING
Richardson
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
Blue Ridge Cancer Care
RECRUITING
Blacksburg
Blue Ridge Cancer Care
RECRUITING
Low Moor
Blue Ridge Cancer Care
RECRUITING
Roanoke
Blue Ridge Cancer Care
RECRUITING
Salem
Blue Ridge Cancer Care
RECRUITING
Wytheville
Washington
Northwest Medical Specialties, PLLC
RECRUITING
Bonney Lake
Northwest Medical Specialties, PLLC
RECRUITING
Federal Way
Northwest Medical Specialties, PLLC
RECRUITING
Gig Harbor
Northwest Medical Specialties, PLLC
RECRUITING
Puyallup
Northwest Medical Specialties, PLLC
RECRUITING
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
NOT_YET_RECRUITING
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
NOT_YET_RECRUITING
Madison
Other Locations
Argentina
Centro Oncologico Korben
NOT_YET_RECRUITING
Buenos Aires
Asociación de Beneficencia Hospital Sirio Libanés
NOT_YET_RECRUITING
Ciudad Autonoma De Buenos Aires
Instituto de Oncología de Rosario
NOT_YET_RECRUITING
Rosario
Sanatorio Británico
RECRUITING
Rosario
Australia
Icon Cancer Centre Chermside
NOT_YET_RECRUITING
Chermside
ICON Cancer Centre - Kurralta Park
NOT_YET_RECRUITING
Kurralta Park
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Orange Health Service
NOT_YET_RECRUITING
Orange
Mater Misericordiae Limited Mater Cancer Care Centre
RECRUITING
South Brisbane
Sydney Adventist Hospital
NOT_YET_RECRUITING
Wahroonga
Belgium
AZORG Campus Aalst-Moorselbaan
NOT_YET_RECRUITING
Aalst
Institut Jules Bordet
NOT_YET_RECRUITING
Anderlecht
AZ Maria Middelares
NOT_YET_RECRUITING
Ghent
AZ Sint-Lucas
NOT_YET_RECRUITING
Ghent
Jessa Ziekenhuis
NOT_YET_RECRUITING
Hasselt
UZ Leuven
RECRUITING
Leuven
Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
RECRUITING
Santo André
Bulgaria
MBAL Uni Hospital
NOT_YET_RECRUITING
Panagyurishte
Complex Oncology Center - Plovdiv EOOD
RECRUITING
Plovdiv
Medical Center Futuremeds
RECRUITING
Plovdiv
Canada
Prostate Cancer Centre
RECRUITING
Calgary
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
RECRUITING
Greenfield Park
Centre of Applied Urology Research/Nova Scotia Health Authority
RECRUITING
Halifax
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
NOT_YET_RECRUITING
Québec
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
RECRUITING
Sherbrooke
Diex Recherche Trois-Rivieres
RECRUITING
Trois-rivières
China
Beijing Friendship Hospital Affiliate of Capital University
RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
Chongqing University Cancer Hospital
RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The Third Affiliated Hospital of Southern Medical University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
NOT_YET_RECRUITING
Hangzhou
First Huai'an Hospital Affiliated to Nanjing Medical University
RECRUITING
Huai'an
Qilu Hospital of Shandong University
RECRUITING
Jinan
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
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Suining Central Hospital
RECRUITING
Suining
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
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Finland
Docrates Syöpäsairaala
RECRUITING
Helsinki
Kuopion Yliopistollinen Sairaala
NOT_YET_RECRUITING
Kuopio
Oulun yliopistollinen sairaala
NOT_YET_RECRUITING
Oulu
Tampereen yliopistollinen sairaala
NOT_YET_RECRUITING
Tampere
Turku University Hospital
NOT_YET_RECRUITING
Turku
Vaasan Keskussairaala
RECRUITING
Vaasa
France
Centre Hospitalier de la Côte Basque
NOT_YET_RECRUITING
Bayonne
CHU Besançon
NOT_YET_RECRUITING
Besançon
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
NOT_YET_RECRUITING
Bordeaux
Groupe Vivalto Santé - Clinique Pasteur-Lanroze
NOT_YET_RECRUITING
Brest
Henri Mondor Hospital
NOT_YET_RECRUITING
Créteil
Centre Leon Berard
NOT_YET_RECRUITING
Lyon Cedex08
Centre Antoine-Lacassagne
NOT_YET_RECRUITING
Nice
Centre Hospitalier Lyon Sud
NOT_YET_RECRUITING
Pierre-bénite
Institut Godinot
NOT_YET_RECRUITING
Reims
Institut Jean Godinot
NOT_YET_RECRUITING
Reims
Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
Charité Universitaetsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Urologie Neandertal - Praxis Mettmann
NOT_YET_RECRUITING
Mettmann
Universitätsklinikum Münster - Albert Schweitzer Campus
NOT_YET_RECRUITING
Münster
Studienpraxis Urologie
NOT_YET_RECRUITING
Nürtingen
Universitaetsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Greece
Metropolitan Hospital
NOT_YET_RECRUITING
Athens
Athens Medical Center S.A -European Interbalkan Medical Center
NOT_YET_RECRUITING
Thessaloniki
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky Medical Center
RECRUITING
Tel Aviv
Yitzhak Shamir Medical Center
RECRUITING
Ẕerifin
Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
NOT_YET_RECRUITING
Novara
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
NOT_YET_RECRUITING
Orbassano
Istituto Nazionale Tumori Regina Elena
NOT_YET_RECRUITING
Rome
IRCCS Istituto Clinico Humanitas
NOT_YET_RECRUITING
Rozzano
ASUIT Trento - Santa Chiara Hospital
NOT_YET_RECRUITING
Trento
Centro Ricerche Cliniche di Verona
NOT_YET_RECRUITING
Verona
Japan
Chiba cancer center
RECRUITING
Chiba
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Kanazawa University Hospital
RECRUITING
Kanazawa
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
Reinier de Graaf Ziekenhuis, locatie Delft
RECRUITING
Delft
Tergooi MC
RECRUITING
Hilversum
Canisius-Wilhelmina Ziekenhuis
NOT_YET_RECRUITING
Nijmegen
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Waikato Hospital
RECRUITING
Hamilton
Palmerston North Hospital
RECRUITING
Palmerston North
Tauranga Hospital
RECRUITING
Tauranga
Poland
Szpitale Pomorskie Sp. z o.o.
NOT_YET_RECRUITING
Gdynia
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
NOT_YET_RECRUITING
Koszalin
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
RECRUITING
Krakow
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o .o.
RECRUITING
Krakow
Clinical Best Solutions Sp. z o.o. S.K.
RECRUITING
Lublin
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k
RECRUITING
Poznan
Centrum Medyczne MEDYK
RECRUITING
Rzeszów
Zachodniopomorskie Centrum Onkologii
RECRUITING
Szczecin
Zachodniopomorskie Centrum Onkologii
RECRUITING
Szczecin
EMC Instytut Medyczny S.A.
RECRUITING
Wroclaw
POLIMED CLINIC Sp. z o.o.
NOT_YET_RECRUITING
Wroclaw
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Deagu
National Cancer Center
RECRUITING
Goyang-si
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun-gun
Chungnam national university hospital
RECRUITING
Junggu
Seoul National University Bundang Hospital
RECRUITING
Seongnam
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
NOT_YET_RECRUITING
Bratislava
Vychodoslovensky onkologicky ustav, a.s.
RECRUITING
Košice
MILAB, s.r.o., Urologicka ambulancia
RECRUITING
Prešov
Privatna urologicka ambulancia, s.r.o.
RECRUITING
Trenčín
Spain
Hospital Clínic de Barcelona
NOT_YET_RECRUITING
Barcelona
Parc de Salut Mar - Hospital del Mar
NOT_YET_RECRUITING
Barcelona
Hospital Clinico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
Althaia, Xarxa Assistencial Universitària de Manresa
NOT_YET_RECRUITING
Manresa
Fundación Instituto Valenciano de Oncología
NOT_YET_RECRUITING
Valencia
Hospital General Universitario de Valencia
NOT_YET_RECRUITING
Valencia
CHUVI- Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Switzerland
Inselspital Bern
NOT_YET_RECRUITING
Bern
Kantonsspital Winterthur
NOT_YET_RECRUITING
Winterthur
UniversitätsSpital Zürich
NOT_YET_RECRUITING
Zurich
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
NOT_YET_RECRUITING
Taoyuan District
United Kingdom
Royal Blackburn Hospital
RECRUITING
Blackburn
Velindre Cancer Centre
NOT_YET_RECRUITING
Cardiff
Western General Hospital
NOT_YET_RECRUITING
Edinburgh
Guy's & St Thomas' NHS Foundation Trust
NOT_YET_RECRUITING
London
Imperial College Healthcare NHS Trust, Charing Cross Hospital
RECRUITING
London
Royal Marsden Hospital (Chelsea)
NOT_YET_RECRUITING
London
Maidstone Hospital
NOT_YET_RECRUITING
Maidstone
The Christie NHS Foundation Trust
RECRUITING
Manchester
Derriford Hospital
NOT_YET_RECRUITING
Plymouth
Torbay Hospital
RECRUITING
Torquay
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-09-28
Estimated Completion Date: 2034-12-08
Participants
Target number of participants: 1000
Treatments
Experimental: Arm A
Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
Active_comparator: Arm B
Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
Related Therapeutic Areas
Sponsors
Leads: Pfizer