A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Castration-Resistant Prostate Cancer
• Intervention / Treatment: Drug: PF-06821497; Drug: Enzalutamide; Drug: Placebo

Detailed Description

This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting.

This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1120
    • Recruiting
    • IMAXE
  • Buenos Aires, Argentina, C1414
    • Recruiting
    • Centro Medico Fleischer
  • Córdoba, Argentina, X5016KEH
    • Recruiting
    • Hospital Privado Centro Médico de Córdoba
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1120AAT
      • Recruiting
      • Centro de Urología (CDU)
    • Capital Federal, Buenos Aires, Argentina, C1419AHN
      • Recruiting
      • Hospital Sírio Libanês
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Recruiting
      • Instituto de Investigaciones Clinicas Mar Del Plata
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Recruiting
      • Imagenes Mdq
  • Córdoba Province
    • Capital, Córdoba Province, Argentina, X5008HHW
      • Recruiting
      • Centro médico privado Cemaic
• Brazil
  • São Paulo, Brazil, 01221-020
    • Recruiting
    • Instituto do Cancer Arnaldo Vieira de Carvalho
  • São Paulo, Brazil, 04014-002
    • Recruiting
    • IBCC - Núcleo de Pesquisa e Ensino
  • Ceará
    • Fortaleza, Ceará, Brazil, 60336232
      • Recruiting
      • Crio - Centro Regional Integrado de Oncologia
    • Fortaleza, Ceará, Brazil, 60135-237
      • Recruiting
      • Hospital São Carlos
    • Fortaleza, Ceará, Brazil, 60130-241
      • Recruiting
      • Oncocentro Servico Medicos e Hospitalares Ltda
    • Fortaleza, Ceará, Brazil, 60135-237
      • Recruiting
      • Oncocentro Oncologia
    • Fortaleza, Ceará, Brazil, 60170-170
      • Recruiting
      • Instituto D'or de Pesquisa e Ensino
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41253-190
      • Recruiting
      • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
    • Salvador, Estado de Bahia, Brazil, 41810-011
      • Recruiting
      • Hospital Da Bahia
    • Salvador, Estado de Bahia, Brazil, 41950-640
      • Recruiting
      • Clinica Amo - Rio Vermelho
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • Recruiting
      • Hospital Sírio Libanês
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59062-000
      • Recruiting
      • Liga Norte Riograndense Contra O Cancer
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Recruiting
      • Hospital São Lucas da PUCRS
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Recruiting
      • Hospital Nossa Senhora da Conceição
    • Porto Alegre, Rio Grande do Sul, Brazil, 91010-004
      • Recruiting
      • MedPlex Eixo Norte
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784400
      • Recruiting
      • Fundação Pio XII - Hospital de Câncer de Barretos
    • Santo André, São Paulo, Brazil, 09060-650
      • Recruiting
      • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
    • São José do Rio Preto, São Paulo, Brazil, 15090000
      • Recruiting
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto
    • São Paulo, São Paulo, Brazil, 01327-001
      • Recruiting
      • Hospital Alemao Oswaldo Cruz
• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • Active, not recruiting
    • Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
  • Pleven, Bulgaria, 5800
    • Recruiting
    • "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
  • Plovdiv, Bulgaria, 4004
    • Recruiting
    • Complex Oncology Center - Plovdiv EOOD
  • Sofia, Bulgaria, 1797
    • Recruiting
    • University Multiprofile Hospital for Active Treatment Sofiamed
  • Stara Zagora, Bulgaria, 6003
    • Recruiting
    • Complex Oncology Center Stara Zagora EOOD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • Recruiting
      • Prostate Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Recruiting
      • Cross Cancer Institute
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • QEII Health Sciences Centre - Victoria General Site
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Recruiting
      • Lakeridge Health
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Recruiting
      • CIUSSS- saguenay-Lac-Saint-Jean
    • Montreal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre Hospitalier de l'Université de Montréal
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4781156
      • Recruiting
      • Centro de Investigacion Clinica del Sur
  • Coquimbo Region
    • La Serena, Coquimbo Region, Chile, 1720430
      • Recruiting
      • IC La Serena Research
  • Maule Region
    • Talca, Maule Region, Chile, 3465584
      • Recruiting
      • Clinica Universidad Catolica del Maule
  • Santiago Metropolitan
    • Providencia, Santiago Metropolitan, Chile, 7500994
      • Recruiting
      • Oncovida
    • Providencia, Santiago Metropolitan, Chile, 7500836
      • Recruiting
      • Fundacion Arturo Lopez Perez
    • Providencia, Santiago Metropolitan, Chile, 7500966
      • Recruiting
      • Fundacion Arturo Lopez Perez
    • Santiago, Santiago Metropolitan, Chile, 8420383
      • Recruiting
      • Bradfordhill
    • Santiago, Santiago Metropolitan, Chile, 7500653
      • Recruiting
      • Centro de Estudios Clinicos SAGA
    • Santiago, Santiago Metropolitan, Chile, 7500921
      • Recruiting
      • FALP
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520598
      • Recruiting
      • Oncocentro APYS
• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
  • Shenyang, China, 110001
    • Recruiting
    • First Affiliated Hospital of China Medical University
  • Anhui
    • Wuhu, Anhui, China, 241001
      • Recruiting
      • Wannan Medical College Yijishan Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Science
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Recruiting
      • Guangzhou First People's Hospital
    • Shantou, Guangdong, China, 515000
      • Recruiting
      • The Second Affiliated Hospital of Shantou University School of Medicine
  • Guangxi
    • Guilin, Guangxi, China, 541199
      • Recruiting
      • The Second Affiliated Hospital of Guilin Medical University
  • Henan
    • Xinxiang, Henan, China, 453003
      • Recruiting
      • The Third Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010017
      • Recruiting
      • Inner Mongolia People's Hospital
  • Jiangsu
    • Huai'an, Jiangsu, China, 223300
      • Recruiting
      • Huai'an first people's hospital
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    • Nantong, Jiangsu, China, 226361
      • Recruiting
      • Nantong Tumor Hospital
    • Suzhou, Jiangsu, China, 215004
      • Recruiting
      • The Second Affiliated Hospital of Soochow University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital Of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China, 710068
      • Recruiting
      • Shaanxi Provincial People' Hospital
  • Shandong
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Shandong Provincial Hospital
    • Qingdao, Shandong, China, 266003
      • Recruiting
      • The Affiliated Hospital of Qingdao University
    • Weifang, Shandong, China, 261041
      • Recruiting
      • Weifang People's Hospital
    • Yantai, Shandong, China, 264099
      • Recruiting
      • Yantai Yuhuangding Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200065
      • Recruiting
      • Tongji Hospital of Tongji University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Recruiting
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    • Ningbo, Zhejiang, China, 315010
      • Recruiting
      • The First Affiliated Hospital of Ningbo University
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
  • Zhejiang/nanhu
    • Jiaxing, Zhejiang/nanhu, China, 314001
      • Recruiting
      • The First Hospital of Jiaxing
• Czechia
  • Liberec, Czechia, 460 63
    • Recruiting
    • Krajska Nemocnice Liberec
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 708 52
      • Recruiting
      • Fakultni Nemocnice Ostrava
    • Ostrava - Poruba, Moravian-Silesian Region, Czechia, 708 52
      • Recruiting
      • Fakultni Nemocnice Ostrava
  • Olomouc Region
    • Olomouc, Olomouc Region, Czechia, 779 00
      • Recruiting
      • Fakultni nemocnice Olomouc
  • Pardubice Region
    • Pardubice, Pardubice Region, Czechia, 53203
      • Recruiting
      • Multiscan
  • Praha 10
    • Prague, Praha 10, Czechia, 10034
      • Recruiting
      • Fakultní nemocnice Královské Vinohrady
  • Praha 2
    • Prague, Praha 2, Czechia, 120 00
      • Recruiting
      • Urocentrum Praha
  • Praha 4
    • Prague, Praha 4, Czechia, 14059
      • Recruiting
      • Fakultni Thomayerova Nemocnice
• Denmark
  • Region Sjælland
    • Næstved, Region Sjælland, Denmark, 4700
      • Recruiting
      • Næstved Sygehus
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Recruiting
      • Odense Universitetshospital
    • Vejle, Region Syddanmark, Denmark, 7100
      • Recruiting
      • Vejle Sygehus
• Finland
  • Helsinki, Finland, 00290
    • Recruiting
    • Helsinki University Hospital
  • North Ostrobothnia
    • Oulu, North Ostrobothnia, Finland, 90220
      • Recruiting
      • Oulun yliopistollinen sairaala
  • Northern Savonia
    • Kuopio, Northern Savonia, Finland, 70210
      • Recruiting
      • Kuopion Yliopistollinen Sairaala
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Recruiting
      • Tampereen yliopistollinen sairaala
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • Recruiting
      • Turku University Hospital
• France
  • Clermont-Ferrand, France, 63011
    • Recruiting
    • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
  • Reims, France, 51100
    • Recruiting
    • Institut Godinot
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33076
      • Recruiting
      • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
  • Auvergne-Rhône-Alpes
    • Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
      • Recruiting
      • Centre Léon Bérard
  • Bas-rhin
    • Strasbourg, Bas-rhin, France, 67098
      • Recruiting
      • Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
  • Finistère
    • Brest, Finistère, France, 29609
      • Recruiting
      • CHRU de Brest
  • Ille-et-vilaine
    • Saint-Grégoire, Ille-et-vilaine, France, 35760
      • Recruiting
      • Centre Hospitalier Privé Saint-Grégoire
  • Loire-atlantique
    • Saint-Herblain, Loire-atlantique, France, 44805
      • Recruiting
      • Institut de Cancerologie de L'Ouest
  • Marne
    • Reims, Marne, France, 51726
      • Recruiting
      • Institut Jean Godinot
  • Pays de la Loire Region
    • Le Mans, Pays de la Loire Region, France, 72000
      • Recruiting
      • Clinique Victor Hugo Le Mans
  • Rhône
    • Pierre-Bénite, Rhône, France, 69310
      • Recruiting
      • Centre Hospitalier Lyon Sud
• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitaetsklinikum Hamburg-Eppendorf
  • Baden-Wurttemberg
    • Nürtingen, Baden-Wurttemberg, Germany, 72622
      • Recruiting
      • Studienpraxis Urologie
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Recruiting
      • Universitaetsklinikum Tuebingen
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Recruiting
      • Universitätsklinikum Münster - Albert Schweitzer Campus
• Greece
  • Achaḯa
    • Pátrai, Achaḯa, Greece, 26504
      • Recruiting
      • University Hospital of Patras
  • Attikí
    • Athens, Attikí, Greece, 115 28
      • Recruiting
      • Alexandra General Hospital of Athens
    • Athens, Attikí, Greece, 151 25
      • Recruiting
      • Athens Medical Center
    • Chaïdári, Attikí, Greece, 124 62
      • Recruiting
      • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
  • Thessalía
    • Larissa, Thessalía, Greece, 411 10
      • Recruiting
      • University General Hospital of Larissa
• Hungary
  • Borsod-Abauj Zemplen county
    • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
      • Recruiting
      • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
  • Győr-Moson-Sopron
    • Győr, Győr-Moson-Sopron, Hungary, 9024
      • Recruiting
      • Petz Aladar Egyetemi Oktato Korhaz
  • Nógrád megye
    • Salgótarján, Nógrád megye, Hungary, 3100
      • Recruiting
      • Nograd Varmegyei Szent Lazar Korhaz
  • Pest County
    • Budapest, Pest County, Hungary, 1122
      • Recruiting
      • Országos Onkológiai Intézet
• Italy
  • Cremona, Italy, 26100
    • Recruiting
    • Azienda Socio Sanitaria Territoriale di Cremona
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Naples, Italy, 80131
    • Recruiting
    • Istituto Nazionale Tumori Irccs Fondazione Pascale
  • Terni, Italy, 05100
    • Recruiting
    • Azienda Ospedaliera Santa Maria Terni
  • Trento, Italy, 38122
    • Recruiting
    • APSS- Presidio Ospedaliero S. Chiara
  • Verona, Italy, 37134
    • Recruiting
    • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • Recruiting
      • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
    • Rome, Lazio, Italy, 00144
      • Recruiting
      • Istituto Nazionale Tumori Regina Elena
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • IRCCS Istituto Clinico Humanitas
• Japan
  • Fukuoka, Japan, 811-1395
    • Recruiting
    • National Hospital Organization Kyushu Cancer Center
  • Kumamoto, Japan, 860-0008
    • Recruiting
    • National Hospital Organization Kumamoto Medical Center
  • Osaka, Japan, 541-8567
    • Recruiting
    • Osaka International Cancer Institute
  • Yamagata, Japan, 990-9585
    • Recruiting
    • Yamagata University Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Recruiting
      • Chiba Cancer Center
    • Kashiwa, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Recruiting
      • National Hospital Organization Shikoku Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Recruiting
      • Hokkaido University Hospital
    • Sapporo, Hokkaido, Japan, 003-0804
      • Recruiting
      • National Hospital Organization Hokkaido Cancer Center
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0017
      • Recruiting
      • Kobe University Hospital
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Recruiting
      • Kanazawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0024
      • Recruiting
      • Yokohama City University Medical Center
    • Yokosuka, Kanagawa, Japan, 238-8558
      • Recruiting
      • Yokosuka Kyosai Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Recruiting
      • The University of Osaka Hospital
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 1608582
      • Recruiting
      • Keio university hospital
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Recruiting
      • Canisius-Wilhelmina Ziekenhuis
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • Not yet recruiting
      • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
  • Provincie Friesland
    • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
      • Recruiting
      • Frisius Medisch Centrum
  • South Holland
    • Schiedam, South Holland, Netherlands, 3118 JH
      • Recruiting
      • Franciscus Gasthuis & Vlietland, Locatie Vlietland
• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Auckland City Hospital
  • Bay of Plenty
    • Tauranga, Bay of Plenty, New Zealand, 3112
      • Recruiting
      • Tauranga Hospital
    • Tauranga, Bay of Plenty, New Zealand, 3112
      • Recruiting
      • Imed Radiology
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Recruiting
      • Christchurch Hospital
  • Waikato Region
    • Hamilton, Waikato Region, New Zealand, 3204
      • Recruiting
      • Waikato Hospital
• Poland
  • Opole, Poland, 45-061
    • Recruiting
    • SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
  • Kuyavian-Pomeranian Voivodeship
    • Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland, 86-300
      • Recruiting
      • Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-348
      • Recruiting
      • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
    • Krakow, Lesser Poland Voivodeship, Poland, 31-826
      • Recruiting
      • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
      • Recruiting
      • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-011
      • Recruiting
      • Clinical Best Solutions
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Recruiting
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
  • West Pomeranian Voivodeship
    • Koszalin, West Pomeranian Voivodeship, Poland, 75-581
      • Recruiting
      • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie
  • Łódź Voivodeship
    • Piotrkow Trybunalski, Łódź Voivodeship, Poland, 97-300
      • Recruiting
      • Provita Profamilia
• Slovakia
  • Bratislava, Slovakia, 851 05
    • Recruiting
    • CUIMED, s.r.o., Urologicka ambulancia
  • Trenčín, Slovakia, 911 01
    • Recruiting
    • Privatna urologicka ambulancia, s.r.o.
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0081
      • Recruiting
      • Wilgers Oncology Centre
    • Soweto, Gauteng, South Africa, 2013
      • Recruiting
      • Wits Clinical Research
  • Western Cape
    • George, Western Cape, South Africa, 6529
      • Recruiting
      • TASK Eden
• South Korea
  • Jeonranamdo
    • Hwasun, Jeonranamdo, South Korea, 58128
      • Recruiting
      • Chonnam National University Hwasun Hospital
  • Kyǒnggi-do
    • Goyang-si, Kyǒnggi-do, South Korea, 10408
      • Recruiting
      • National Cancer Center
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
      • Recruiting
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 05505
      • Recruiting
      • Asan Medical Center
  • Taegu-kwangyǒkshi
    • Daegu, Taegu-kwangyǒkshi, South Korea, 41404
      • Recruiting
      • Kyungpook National University Chilgok Hospital
  • Taejǒn-kwangyǒkshi
    • Junggu, Taejǒn-kwangyǒkshi, South Korea, 35015
      • Recruiting
      • Chungnam National University Hospital
• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Universitario HM Sanchinarro
  • Catalunya [cataluña]
    • L'Hospitalet de Llobregat, Catalunya [cataluña], Spain, 08908
      • Recruiting
      • Institut Catala d'Oncologia - L'Hospitalet
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Recruiting
      • Hospital Universitario 12 de Octubre
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46009
      • Recruiting
      • Fundacion Instituto Valenciano de Oncologia
• Sweden
  • Stockholms LÄN [se-01]
    • Stockholm, Stockholms LÄN [se-01], Sweden, 11883
      • Recruiting
      • Södersjukhuset
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 407
    • Recruiting
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 100225
    • Recruiting
    • National Taiwan University Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06010
    • Recruiting
    • Sbü Gülhane Eğitim Ve Araştirma Hastanesi
  • Ankara, Turkey (Türkiye), 06620
    • Recruiting
    • Ankara University Health Practice and Research Hospitals
  • Ankara, Turkey (Türkiye), 06520
    • Recruiting
    • Memorial Ankara Hastanesi
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34010
      • Recruiting
      • Koc Universitesi Hastanesi
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34722
      • Recruiting
      • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34899
      • Recruiting
      • Marmara Universitesi Pendik Egitim Arastirma Hastanesi
  • İ̇zmir
    • Izmir, İ̇zmir, Turkey (Türkiye), 009035575
      • Recruiting
      • I.E.U. Medical Point Hastanesi
• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • Recruiting
    • Royal Derby Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Recruiting
    • The Beatson West of Scotland Cancer Centre
  • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    • Not yet recruiting
    • The Clatterbridge Cancer Centre
  • Blackburn WITH Darwen
    • Blackburn, Blackburn WITH Darwen, United Kingdom, BB2 3HH
      • Recruiting
      • Royal Blackburn Hospital
  • Essex
    • Chelmsford, Essex, United Kingdom, CM1 7ET
      • Recruiting
      • Mid and South Essex NHS Foundation Trust
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Ironwood Cancer & Research Centers
    • Gilbert, Arizona, United States, 85297
      • Recruiting
      • Ironwood Cancer & Research Centers
    • Glendale, Arizona, United States, 85304
      • Recruiting
      • Palo Verde Hematology Oncology
    • Glendale, Arizona, United States, 85306
      • Recruiting
      • Ironwood Cancer & Research Centers
    • Goodyear, Arizona, United States, 85395
      • Recruiting
      • Ironwood Cancer & Research Centers
    • Mesa, Arizona, United States, 85202
      • Recruiting
      • Ironwood Cancer & Research Centers
    • Mesa, Arizona, United States, 85206
      • Recruiting
      • Ironwood Cancer & Research Centers
    • Phoenix, Arizona, United States, 85028
      • Recruiting
      • Ironwood Cancer & Research Centers
    • Scottsdale, Arizona, United States, 85260
      • Recruiting
      • Ironwood Cancer & Research Centers
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Recruiting
      • Highlands Oncology
    • Little Rock, Arkansas, United States, 72211
      • Recruiting
      • Arkansas Urology - Little Rock
    • Rogers, Arkansas, United States, 72758
      • Recruiting
      • Highlands Oncology
    • Springdale, Arkansas, United States, 72762
      • Recruiting
      • Highlands Oncology Group
  • California
    • Anaheim, California, United States, 92805
      • Recruiting
      • Los Angeles Cancer Network (LACN)
    • Fountain Valley, California, United States, 92708
      • Recruiting
      • Los Angeles Cancer Network (LACN)
    • Glendale, California, United States, 91204
      • Recruiting
      • Los Angeles Cancer Network (LACN)
    • Glendale, California, United States, 91206
      • Recruiting
      • Los Angeles Cancer Network (LACN)
    • Laguna Hills, California, United States, 92653
      • Recruiting
      • Los Angeles Cancer Network (LACN)
    • Los Angeles, California, United States, 90017
      • Recruiting
      • Los Angeles Cancer Network (LACN)
    • Los Angeles, California, United States, 90067
      • Recruiting
      • Los Angeles Cancer Network (LACN)
    • San Diego, California, United States, 92123
      • Recruiting
      • Medical Oncology Associates of San Diego
  • Illinois
    • Lisle, Illinois, United States, 60532
      • Recruiting
      • Duly Health and Care (Bone Scintigraphy)
    • Lisle, Illinois, United States, 60532
      • Recruiting
      • Accellacare of Duly
    • Quincy, Illinois, United States, 62301
      • Recruiting
      • Blessing Hospital
    • Quincy, Illinois, United States, 62301
      • Recruiting
      • Blessing Physician Services
    • Westmont, Illinois, United States, 60559
      • Recruiting
      • Duly Health and Care (CT and MRI)
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Adult & Pediatric Urology, PC
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Recruiting
      • CHRISTUS St. Vincent Regional Cancer Center
  • New York
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
    • The Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center - Medical Park
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Recruiting
      • Salisbury VA Medical Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Carolina Urologic Research Center, LLC
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Parkway Surgery Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Grand Strand Medical Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • AUC Urologists, LLC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • USA Clinical Trials
  • Washington
    • Bonney Lake, Washington, United States, 98391
      • Recruiting
      • Northwest Medical Specialties, PLLC
    • Federal Way, Washington, United States, 98003
      • Recruiting
      • Northwest Medical Specialties, PLLC
    • Gig Harbor, Washington, United States, 98332
      • Recruiting
      • Northwest Medical Specialties, PLLC
    • Puyallup, Washington, United States, 98373
      • Recruiting
      • Northwest Medical Specialties, PLLC
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington Medical Center - Montlake
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Harborview Medical Center
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.
• Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
• Clinically significant cardiovascular disease.
• Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
• Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.

• Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:

  1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
  2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
• Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
• Inadequate organ function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Participants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)	Drug: PF-06821497; Oral continuous; Other Names: Mevrometostat; Drug: Enzalutamide; Oral continuous; Other Names: Xtandi
Active Comparator: Arm B; Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)	Drug: Enzalutamide; Oral continuous; Other Names: Xtandi; Drug: Placebo; Oral continuous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Progression Free Survival (rPFS)	rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.	Randomization up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause.	Randomization up to approximately 5 years
Time to prostate specific antigen (PSA) progression.	Time from the date of randomization to the date of the first PSA progression. PSA progression is defined as a ≥25% increase in PSA with an absolute increase of ≥2 ng/mL above the nadir (or baseline for participants with no PSA decline), confirmed by a second consecutive PSA value at least 21 days later.	Randomization up to approximately 3 years
Prostate Specific Antigen Response	Proportion of participants with PSA response ≥50% in participants with detectable PSA values at baseline.	Randomization up to approximately 3 years.
Time to first symptomatic skeletal event	Time from randomization to first symptomatic skeletal event (symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first).	Randomization up to approximately 3 years.
Incidence of Adverse Events	Type, incidence, severity [as graded by National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v5.0], seriousness and relationship to study medications of AEs.	Randomization up to approximately 5 years
To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden.	Evaluation of ctDNA burden at baseline and on study.	Baseline up to approximately 3 years.
To evaluate the PK of PF-06821497 when dosed with enzalutamide	PK characterized by pre-dose trough and post-dose plasma concentrations of PF-06821497 at selected visits	Cycle 1 Day 15 to last PK draw at Cycle 6 Day 1 (cycle length is 28 days)
Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)	Analysis of Brief Pain Inventory-Short Form (BPI-SF) will be based on the pain severity score (mean of individual BPI-SF items 3, 4, 5 and 6), the pain interference score (mean of items 9A-9G), and the single BPI-SF Item 3 which asks the patient to rate pain at its worst in the last 24 hours.	Randomization up to approximately 5 years
Change from baseline in BPI-SF Item 3 (Worst Pain) at Cycle 7 Day 1 (Week 25)	Analysis of Brief Pain Inventory-Short Form (BPI-SF) will be based on the pain severity score (mean of individual BPI-SF items 3, 4, 5 and 6), the pain interference score (mean of items 9A-9G), and the single BPI-SF Item 3 which asks the patient to rate pain at its worst in the last 24 hours.	Randomization up to Week 25
Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)	Change from baseline in HRQoL (FACT-P total score) will be presented. The FACT-P total score will be calculated based on the participant responses to the 39 items in the FACT-P questionnaire. Each item is rated on a 0 to 4 Likert-type scale and then combined to produce the FACT-P total score (0-156), with higher scores representing better health-related quality of life.	Randomization up to approximately 5 years
Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)	Participants will self-rate their current state of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression by choosing 1 of 5 possible responses that record the level of severity (no problems, slight problems, moderate problems, severe problems, or extreme problems) within each dimension. The questionnaire also includes a visual analog scale to self-rate general health state on a scale from "the worst health you can imagine" to "the best health you can imagine."	Randomization up to approximately 5 years
Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)	Each selected PRO-CTCAE items will be assessed related to one or more attributes that include counts for the frequency, severity, and/or interference with usual or daily activities.	Randomization up to approximately 5 years
Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P	Defined as the time from randomization to onset of definitive deterioration in FACT-P total score, which is defined as >10 point decrease from baseline and no subsequent observations with a <10 point decrease from baseline FACT-P total score	Randomization up to approximately 5 years
To demonstrate that PF-06821497 in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging Time To Pain Progression (TTPP)	TTPP (alpha protected): assessed using time to first ≥2-point increase from baseline score on BPI-SF Item 3 (Worst Pain) observed at 2 consecutive visits or the initiation of short- or long-acting opioid use for pain	Randomization up to approximately 5 years
Objective Response Rate (ORR)	The objective response rate is defined as the proportion of participants with measurable soft tissue disease at baseline who have a confirmed objective response of complete response (CR) or partial response (PR) per RECIST v1.1 by BICR	Randomization up to approximately 3 years
Duration of Response (DoR) in measurable soft tissue disease	The DoR is defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression per BICR or death due to any cause whichever occurs first.	Randomization up to approximately 3 years.
Time to initiation of antineoplastic therapy.	Time from randomization to first use of new antineoplastic therapy.	Randomization up to approximately 5 years.
Time to initiation of cytotoxic chemotherapy.	Time from randomization to first use of new cytotoxic chemotherapy.	Randomization up to approximately 5 years
Progression free survival on next line of therapy	the time from the date of randomization to the first occurrence of investigator-determined disease progression (PSA progression, progression on imaging, or clinical progression) or death due to any cause, whichever occurs first, while the participant was receiving first subsequent therapy for prostate cancer.	Randomization up to approximately 5 years
Overall side effect burden as measured by the FACT- GP5	The FACT-GP5 question assesses overall side effect burden with the following response options "I am bothered by side effects of treatment," is rated on a 5-point scale ranging from "not at all" (0) to "very much" (4) and counts will be presented.	Randomization to approximately 5 years

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Shore ND, Fizazi K, Schweizer MT, Castro E, Azad AA, George DJ, da Trindade KM, Zeng H, Shrivastava N, Tonkovyd S, Bock A, Nekkalapudi S, Tang Y, Lin S, Agarwal N. Phase III randomized studies of mevrometostat and enzalutamide in metastatic prostate cancer (MEVPRO-1 and MEVPRO-2): trial protocols. Future Oncol. 2026 May 10:1-12. doi: 10.1080/14796694.2026.2667441. Online ahead of print.

Helpful Links

• To obtain contact information for a study center near you, click here.
• www.mevpro2.com

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: safety; pharmacokinetics; efficacy; enzalutamide; mCRPC; pharmacodynamics; EZH2; castrate resistant prostate cancer; Prostrate Cancer; PF-06821497; prostatecancer-study.com; MEVROMETOSTAT; METASTATIC CASTRATION RESISTANT PROSTATE CANCER; enhancer of zeste homologue-2
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Substandard Drugs; Pharmaceutical Preparations; enzalutamide; PF06821497
• Other Study ID Numbers: C2321003; 2024-511652-40-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No