A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)
Status: Recruiting
Location: See all (223) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.
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 medical or surgical castration.
• ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.
Locations
United States
Arkansas
Highlands Oncology
RECRUITING
Fayetteville
Arkansas Urology - Little Rock
RECRUITING
Little Rock
Highlands Oncology
RECRUITING
Rogers
Highlands Oncology Group
RECRUITING
Springdale
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
Ironwood Cancer & Research Centers
RECRUITING
Gilbert
Ironwood Cancer & Research Centers
RECRUITING
Glendale
Palo Verde Hematology Oncology
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
Arizona Urology Specialists (AUS)-Orange Grove
RECRUITING
Tucson
California
Los Angeles Cancer Network (LACN)
RECRUITING
Anaheim
Los Angeles Cancer Network (LACN)
RECRUITING
Fountain Valley
Los Angeles Cancer Network (LACN)
RECRUITING
Glendale
Los Angeles Cancer Network (LACN)
RECRUITING
Glendale
Adventist Health Physicians Network
RECRUITING
Hidden Valley Lake
Los Angeles Cancer Network (LACN)
RECRUITING
Los Angeles
Los Angeles Cancer Network (LACN)
RECRUITING
Los Angeles
Adventist Health Physicians Network
RECRUITING
Napa
Medical Oncology Associates of San Diego
NOT_YET_RECRUITING
San Diego
Adventist Health St. Helena
RECRUITING
St. Helena
Illinois
Accellacare of Duly
RECRUITING
Lisle
Duly Health and Care (Bone Scintigraphy)
RECRUITING
Lisle
Blessing Hospital
RECRUITING
Quincy
Blessing Physician Services
RECRUITING
Quincy
Duly Health and Care (CT and MRI)
RECRUITING
Westmont
North Carolina
Salisbury VA Medical Center
RECRUITING
Salisbury
Nebraska
Adult & Pediatric Urology, PC
RECRUITING
Omaha
New Mexico
CHRISTUS St. Vincent Regional Cancer Center
RECRUITING
Santa Fe
New York
Montefiore Medical Center - Medical Park
RECRUITING
The Bronx
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
Texas
USA Clinical Trials
RECRUITING
San Antonio
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
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Harborview Medical Center
RECRUITING
Seattle
University of Washington Medical Center - Montlake
RECRUITING
Seattle
Northwest Medical Specialties, PLLC
RECRUITING
Tacoma
Other Locations
Argentina
Asociación de Beneficencia Hospital Sirio Libanés
RECRUITING
Buenos Aires
Centro Medico Fleischer
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
Hospital Privado Universitario de Córdoba
RECRUITING
Córdoba
Imagenes Mdq
RECRUITING
Mar Del Plata
Instituto de Investigaciones Clínicas Mar del Plata
RECRUITING
Mar Del Plata
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
RECRUITING
Barretos
Crio - Centro Regional Integrado de Oncologia
RECRUITING
Fortaleza
Hospital São Carlos
RECRUITING
Fortaleza
Oncocentro Oncologia
RECRUITING
Fortaleza
Oncocentro Servico Medicos e Hospitalares Ltda
RECRUITING
Fortaleza
Liga Norte Riograndense Contra o Câncer
RECRUITING
Natal
Hospital Nossa Senhora da Conceição
RECRUITING
Porto Alegre
Hospital São Lucas da PUCRS
RECRUITING
Porto Alegre
MedPlex Eixo Norte
RECRUITING
Porto Alegre
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
RECRUITING
Salvador
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 Alemao Oswaldo Cruz
RECRUITING
São Paulo
IBCC - Núcleo de Pesquisa e Ensino
RECRUITING
São Paulo
Bulgaria
Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
RECRUITING
Gabrovo
University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
RECRUITING
Pleven
Complex Oncology Center - Plovdiv EOOD
RECRUITING
Plovdiv
University Multiprofile Hospital for Active Treatment Sofiamed
RECRUITING
Sofia
Complex Oncology Center Stara Zagora EOOD
RECRUITING
Stara Zagora
Canada
Prostate Cancer Centre
RECRUITING
Calgary
CIUSSS- saguenay-Lac-Saint-Jean
RECRUITING
Chicoutimi
Cross Cancer Institute
RECRUITING
Edmonton
QEII Health Sciences Centre - Victoria General Site
RECRUITING
Halifax
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Lakeridge Health
RECRUITING
Oshawa
Chile
IC La Serena Research
NOT_YET_RECRUITING
La Serena
Oncovida
RECRUITING
Providencia
Bradfordhill
RECRUITING
Santiago
Centro de Estudios Clínicos SAGA
RECRUITING
Santiago
Clinica Universidad Catolica del Maule
RECRUITING
Talca
Centro de Investigacion Clinica del Sur
RECRUITING
Temuco
China
Cancer Hospital Chinese Academy of Medical Science
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Guangzhou First People's Hospital
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Guilin Medical University
RECRUITING
Guilin
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Inner Mongolia People's Hospital
RECRUITING
Hohhot
Huai'an First People's Hospital
RECRUITING
Huai'an
The First Hospital of Jiaxing
RECRUITING
Jiaxing
Shandong Provincial Hospital
RECRUITING
Jinan
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
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Tongji Hospital of Tongji University
RECRUITING
Shanghai
The Second Affiliated Hospital of Shantou University School of Medicine
RECRUITING
Shantou
First Affiliated Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Weifang People's Hospital
RECRUITING
Weifang
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
The Third Affiliated Hospital of Xinxiang Medical University
RECRUITING
Xinxiang
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Henan Cancer Hospital
RECRUITING
Zhengzhou
Denmark
Næstved Sygehus
RECRUITING
Næstved
Odense Universitetshospital
RECRUITING
Odense
Vejle Sygehus
RECRUITING
Vejle
Finland
Helsinki university hospital
RECRUITING
Helsinki
Kuopion Yliopistollinen Sairaala
RECRUITING
Kuopio
Oulun yliopistollinen sairaala
RECRUITING
Oulu
Tampereen yliopistollinen sairaala
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
RECRUITING
Bordeaux
CHRU de Brest
RECRUITING
Brest
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
RECRUITING
Clermont-ferrand
Clinique Victor Hugo Le Mans
RECRUITING
Le Mans
Centre Leon Berard
RECRUITING
Lyon Cedex08
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Institut Godinot
RECRUITING
Reims
Institut Jean Godinot
RECRUITING
Reims
Centre Hospitalier Privé Saint-Grégoire
RECRUITING
Saint-grégoire
Institut de Cancérologie de l'Ouest
RECRUITING
Saint-herblain
Institut de cancérologie Strasbourg Europe (ICANS)
RECRUITING
Strasbourg
Germany
Universitaetsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
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
University General Hospital ATTIKON - General Hospital of West Attica H AGIA VARVARA
RECRUITING
Chaïdári
University General Hospital of Larissa
RECRUITING
Larissa
University Hospital of Patras
RECRUITING
Pátrai
Hungary
Országos Onkológiai Intézet
RECRUITING
Budapest
Petz Aladar Egyetemi Oktato Korhaz
RECRUITING
Győr
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
RECRUITING
Miskolc
Nograd Varmegyei Szent Lazar Korhaz
RECRUITING
Salgótarján
Italy
Azienda Socio Sanitaria Territoriale di Cremona
RECRUITING
Cremona
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
RECRUITING
Meldola
Ospedale San Raffaele
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale
NOT_YET_RECRUITING
Napoli
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
RECRUITING
Rome
Istituto Nazionale Tumori Regina Elena
RECRUITING
Rome
Azienda Ospedaliera Santa Maria Terni
RECRUITING
Terni
APSS- Presidio Ospedaliero S. Chiara
RECRUITING
Trento
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
RECRUITING
Verona
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
Frisius Medisch Centrum
RECRUITING
Leeuwarden
Canisius-Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Franciscus Gasthuis & Vlietland, Locatie Vlietland
RECRUITING
Schiedam
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Waikato Hospital
RECRUITING
Hamilton
Imed Radiology
RECRUITING
Tauranga
Tauranga Hospital
RECRUITING
Tauranga
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
Clinical Best Solutions
RECRUITING
Lublin
Provita Profamilia
RECRUITING
Piotrkow Trybunalski
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
Chungnam national university hospital
RECRUITING
Junggu
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Slovakia
CUIMED, s.r.o., Urologicka ambulancia
RECRUITING
Bratislava
Univerzitna nemocnica Martin
RECRUITING
Martin
Privatna urologicka ambulancia, s.r.o.
RECRUITING
Trenčín
South Africa
TASK Eden
RECRUITING
George
Cancercare Langenhoven Drive Oncology Centre
RECRUITING
Port Elizabeth
Wilgers Oncology Centre
RECRUITING
Pretoria
Wits Clinical Research
RECRUITING
Soweto
Spain
Institut Català d'Oncologia - L'Hospitalet
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Fundación Instituto Valenciano de Oncología
RECRUITING
Valencia
Sweden
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
Turkey
Ankara University Health Practice and Research Hospitals
RECRUITING
Ankara
Memorial Ankara Hastanesi
RECRUITING
Ankara
Sbü Gülhane Eğitim Ve Araştirma Hastanesi
RECRUITING
Ankara
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
The Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
The Clatterbridge Cancer Centre
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 900
Treatments
Experimental: Arm A
Participants will receive 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