AzTrials
AzTrials

Metastatic Castration-Resistant Prostate CancerPhase 3NCT06629779

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

A Phase 3 study testing PF-06821497 and Enzalutamide in people with Metastatic Castration-Resistant Prostate Cancer, run by Pfizer at 231 sites in 27 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
PF-06821497 and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
900 participants
Where
231 sitesin 27 countries
Study dates
22 Oct 2024to 30 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
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  • Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
  • 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.

Trial locations and contacts

231 sites in 27 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

231 sites in 27 countries

United States39 sites, 39 recruiting

  • Los Angeles Cancer Network (LACN)

    Anaheim, California, 92805

    Recruiting

  • Northwest Medical Specialties, PLLC

    Bonney Lake, Washington, 98391

    Recruiting

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

    Recruiting

  • Highlands Oncology

    Fayetteville, Arkansas, 72703

    Recruiting

  • Northwest Medical Specialties, PLLC

    Federal Way, Washington, 98003

    Recruiting

  • Los Angeles Cancer Network (LACN)

    Fountain Valley, California, 92708

    Recruiting

  • Northwest Medical Specialties, PLLC

    Gig Harbor, Washington, 98332

    Recruiting

  • Ironwood Cancer & Research Centers

    Gilbert, Arizona, 85297

    Recruiting

  • Palo Verde Hematology Oncology

    Glendale, Arizona, 85304

    Recruiting

  • Ironwood Cancer & Research Centers

    Glendale, Arizona, 85306

    Recruiting

  • Los Angeles Cancer Network (LACN)

    Glendale, California, 91204

    Recruiting

  • Los Angeles Cancer Network (LACN)

    Glendale, California, 91206

    Recruiting

  • Ironwood Cancer & Research Centers

    Goodyear, Arizona, 85395

    Recruiting

  • Los Angeles Cancer Network (LACN)

    Laguna Hills, California, 92653

    Recruiting

  • Arkansas Urology - Little Rock

    Little Rock, Arkansas, 72211

    Recruiting

  • Los Angeles Cancer Network (LACN)

    Los Angeles, California, 90017

    Recruiting

  • Los Angeles Cancer Network (LACN)

    Los Angeles, California, 90067

    Recruiting

  • Ironwood Cancer & Research Centers

    Mesa, Arizona, 85202

    Recruiting

  • Ironwood Cancer & Research Centers

    Mesa, Arizona, 85206

    Recruiting

  • AUC Urologists, LLC

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Parkway Surgery Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Ironwood Cancer & Research Centers

    Phoenix, Arizona, 85028

    Recruiting

  • Northwest Medical Specialties, PLLC

    Puyallup, Washington, 98373

    Recruiting

  • Blessing Hospital

    Quincy, Illinois, 62301

    Recruiting

  • Blessing Physician Services

    Quincy, Illinois, 62301

    Recruiting

  • Highlands Oncology

    Rogers, Arkansas, 72758

    Recruiting

  • USA Clinical Trials

    San Antonio, Texas, 78229

    Recruiting

  • Medical Oncology Associates of San Diego

    San Diego, California, 92123

    Recruiting

  • CHRISTUS St. Vincent Regional Cancer Center

    Santa Fe, New Mexico, 87505

    Recruiting

  • Ironwood Cancer & Research Centers

    Scottsdale, Arizona, 85260

    Recruiting

  • Harborview Medical Center

    Seattle, Washington, 98104

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Recruiting

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

    Recruiting

  • Montefiore Medical Center - Medical Park

    The Bronx, New York, 10461

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

Other trials in United States

China30 sites, 30 recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

    Recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

    Recruiting

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541199

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Recruiting

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, 010017

    Recruiting

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223300

    Recruiting

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang/nanhu, 314001

    Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

    Recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226361

    Recruiting

  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang, 315010

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

    Recruiting

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

    Recruiting

  • The Second Affiliated Hospital of Shantou University School of Medicine

    Shantou, Guangdong, 515000

    Recruiting

  • First Affiliated Hospital of China Medical University

    Shenyang, 110001

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

    Recruiting

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211

    Recruiting

  • Weifang People's Hospital

    Weifang, Shandong, 261041

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Recruiting

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Recruiting

  • Shaanxi Provincial People' Hospital

    Xi'an, Shaanxi, 710068

    Recruiting

  • The Third Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453003

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Recruiting

Other trials in China

Brazil19 sites, 19 recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784400

    Recruiting

  • Hospital Sirio Libanes

    Brasília, Federal District, 70200-730

    Recruiting

  • Oncocentro Servico Medicos e Hospitalares Ltda

    Fortaleza, Ceará, 60130-241

    Recruiting

  • Hospital São Carlos

    Fortaleza, Ceará, 60135-237

    Recruiting

  • Oncocentro Oncologia

    Fortaleza, Ceará, 60135-237

    Recruiting

  • Instituto D'Or de Pesquisa e Ensino

    Fortaleza, Ceará, 60170-170

    Recruiting

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336232

    Recruiting

  • Liga Norte Riograndense Contra o Câncer

    Natal, Rio Grande do Norte, 59062-000

    Recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

    Recruiting

  • MedPlex Eixo Norte

    Porto Alegre, Rio Grande do Sul, 91010-004

    Recruiting

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande do Sul, 91350-200

    Recruiting

  • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador

    Salvador, Estado de Bahia, 41253-190

    Recruiting

  • Clinica Amo - Rio Vermelho

    Salvador, Estado de Bahia, 41950- 640

    Recruiting

  • Clinica Amo - Rio Vermelho

    Salvador, Estado de Bahia, 41950-640

    Recruiting

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, São Paulo, 09060-650

    Recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090000

    Recruiting

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327-001

    Recruiting

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, 01221-020

    Recruiting

  • IBCC - Núcleo de Pesquisa e Ensino

    São Paulo, 04014-002

    Recruiting

Other trials in Brazil

Japan15 sites

  • Chiba cancer center

    Chiba, Chiba, 260-8717

    Active, not recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

    Active, not recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

    Active, not recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Active, not recruiting

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

    Active, not recruiting

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

    Active, not recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

    Active, not recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Active, not recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

    Active, not recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Active, not recruiting

  • Keio university hospital

    Shinjuku-ku, Tokyo, 1608582

    Active, not recruiting

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871

    Active, not recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    Active, not recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

    Active, not recruiting

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa, 238-8558

    Active, not recruiting

Other trials in Japan

France11 sites, 11 recruiting

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine, 33076

    Recruiting

  • CHRU de Brest

    Brest, Finistère, 29609

    Recruiting

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

    Clermont-Ferrand, 63011

    Recruiting

  • Clinique Victor Hugo Le Mans

    Le Mans, Pays de la Loire Region, 72000

    Recruiting

  • Centre Leon Berard

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373

    Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhône, 69310

    Recruiting

  • Institut Jean Godinot

    Reims, Marne, 51726

    Recruiting

  • Institut Godinot

    Reims, 51100

    Recruiting

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire, Ille-et-vilaine, 35760

    Recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire-atlantique, 44805

    Recruiting

  • Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

    Strasbourg, Bas-rhin, 67098

    Recruiting

Other trials in France

Chile10 sites, 9 recruiting

  • IC La Serena Research

    La Serena, Coquimbo Region, 1720430

    Recruiting

  • Fundación Arturo López Pérez

    Providencia, Santiago Metropolitan, 7500836

    Recruiting

  • Fundacion Arturo Lopez Perez

    Providencia, Santiago Metropolitan, 7500966

    Recruiting

  • Oncovida

    Providencia, Santiago Metropolitan, 7500994

    Recruiting

  • Centro de Estudios Clínicos SAGA

    Santiago, Santiago Metropolitan, 7500653

    Recruiting

  • FALP

    Santiago, Santiago Metropolitan, 7500921

    Recruiting

  • Bradfordhill

    Santiago, Santiago Metropolitan, 8420383

    Active, not recruiting

  • Clinica Universidad Catolica del Maule

    Talca, Maule Region, 3465584

    Recruiting

  • Centro de Investigacion Clinica del Sur

    Temuco, Araucania, 4781156

    Recruiting

  • Oncocentro Apys

    Viña del Mar, Valparaiso, 2520598

    Recruiting

Other trials in Chile

Italy10 sites, 8 recruiting

  • Azienda Socio Sanitaria Territoriale di Cremona

    Cremona, 26100

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-Romagna, 47014

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

    Active, not recruiting

  • Istituto Nazionale Tumori Regina Elena

    Rome, Lazio, 00144

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Rome, Lazio, 00168

    Active, not recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Milano, 20089

    Recruiting

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100

    Recruiting

  • APSS- Presidio Ospedaliero S. Chiara

    Trento, 38122

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

    Verona, 37134

    Recruiting

Other trials in Italy

Argentina8 sites, 8 recruiting

  • IMAXE

    Buenos Aires, C1120

    Recruiting

  • Centro Medico Fleischer

    Buenos Aires, C1414

    Recruiting

  • Centro de Urología (CDU)

    CABA, Buenos Aires, C1120AAT

    Recruiting

  • Centro Medico Privado CEMAIC

    Capital, Córdoba Province, X5008HHW

    Recruiting

  • Hospital Sirio Libanes

    Capital Federal, Buenos Aires, C1419AHN

    Recruiting

  • Hospital Privado Centro Médico de Córdoba

    Córdoba, X5016KEH

    Recruiting

  • Imagenes Mdq

    Mar del Plata, Buenos Aires, B7600FZO

    Recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZO

    Recruiting

Other trials in Argentina

Czechia8 sites

  • Krajská nemocnice Liberec

    Liberec, 460 63

    Active, not recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region, 779 00

    Active, not recruiting

  • Fakultní nemocnice Ostrava

    Ostrava - Poruba, Moravian-Silesian Region, 708 52

    Active, not recruiting

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52

    Active, not recruiting

  • Multiscan

    Pardubice, Pardubice Region, 53203

    Active, not recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Praha 10, 10034

    Active, not recruiting

  • Urocentrum Praha

    Prague, Praha 2, 120 00

    Active, not recruiting

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 14059

    Active, not recruiting

Other trials in Czechia

Poland8 sites, 8 recruiting

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie

    Koszalin, West Pomeranian Voivodeship, 75-581

    Recruiting

  • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

    Krakow, Lesser Poland Voivodeship, 30-348

    Recruiting

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-826

    Recruiting

  • Clinical Best Solutions

    Lublin, Lublin Voivodeship, 20-011

    Recruiting

  • SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

    Opole, 45-061

    Recruiting

  • Provita Profamilia

    Piotrkow Trybunalski, Łódź Voivodeship, 97-300

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

    Warsaw, Masovian Voivodeship, 02-781

    Recruiting

  • 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

    Wroclaw, Lower Silesian Voivodeship, 50-981

    Recruiting

Other trials in Poland

South Korea8 sites, 8 recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, Taegu-kwangyǒkshi, 41404

    Recruiting

  • National Cancer Center

    Goyang-si, Kyǒnggi-do, 10408

    Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeonranamdo, 58128

    Recruiting

  • Chungnam national university hospital

    Junggu, Taejǒn-kwangyǒkshi, 35015

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722

    Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05505

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351

    Recruiting

Other trials in South Korea

Turkey (Türkiye)7 sites, 7 recruiting

  • Sbü Gülhane Eğitim Ve Araştirma Hastanesi

    Ankara, 06010

    Recruiting

  • Memorial Ankara Hastanesi

    Ankara, 06520

    Recruiting

  • Ankara University Health Practice and Research Hospitals

    Ankara, 06620

    Recruiting

  • Koç Üniversitesi Hastanesi

    Istanbul, İ̇stanbul, 34010

    Recruiting

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, İ̇stanbul, 34722

    Recruiting

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Istanbul, İ̇stanbul, 34899

    Recruiting

  • I.E.U. Medical Point Hastanesi

    Izmir, İ̇zmir, 009035575

    Recruiting

Other trials in Turkey (Türkiye)

Canada6 sites, 6 recruiting

  • Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

    Recruiting

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6

    Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • QEII Health Sciences Centre - Victoria General Site

    Halifax, Nova Scotia, B3H 2Y9

    Recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3E4

    Recruiting

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9

    Recruiting

Other trials in Canada

Finland5 sites, 5 recruiting

  • Helsinki university hospital

    Helsinki, 00290

    Recruiting

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Northern Savonia, 70210

    Recruiting

  • Oulun yliopistollinen sairaala

    Oulu, North Ostrobothnia, 90220

    Recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520

    Recruiting

  • Turku University Hospital

    Turku, Southwest Finland, 20520

    Recruiting

Other trials in Finland

Greece5 sites, 5 recruiting

  • Alexandra General Hospital of Athens

    Athens, Attikí, 115 28

    Recruiting

  • Athens Medical Center

    Athens, Attikí, 151 25

    Recruiting

  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

    Chaïdári, Attikí, 124 62

    Recruiting

  • University General Hospital of Larissa

    Larissa, Thessalía, 411 10

    Recruiting

  • University Hospital of Patras

    Pátrai, Achaḯa, 26504

    Recruiting

Other trials in Greece

New Zealand5 sites, 5 recruiting

  • Auckland City Hospital

    Auckland, 1023

    Recruiting

  • Christchurch Hospital

    Christchurch, Canterbury, 8011

    Recruiting

  • Waikato Hospital

    Hamilton, Waikato Region, 3204

    Recruiting

  • Imed Radiology

    Tauranga, Bay of Plenty, 3112

    Recruiting

  • Tauranga Hospital

    Tauranga, Bay of Plenty, 3112

    Recruiting

Other trials in New Zealand

Spain5 sites, 5 recruiting

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet de Llobregat, Catalunya [cataluña], 08908

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

    Recruiting

  • Fundación Instituto Valenciano de Oncología

    Valencia, Valenciana, Comunitat, 46009

    Recruiting

Other trials in Spain

Taiwan5 sites, 5 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

United Kingdom5 sites, 5 recruiting

  • Royal Blackburn Hospital

    Blackburn, Blackburn WITH Darwen, BB2 3HH

    Recruiting

  • Mid and South Essex NHS Foundation Trust

    Chelmsford, Essex, CM1 7ET

    Recruiting

  • Royal Derby Hospital

    Derby, DE22 3NE

    Recruiting

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    Recruiting

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

    Recruiting

Other trials in United Kingdom

Germany4 sites, 4 recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, 48149

    Recruiting

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

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Hungary4 sites, 4 recruiting

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Netherlands4 sites, 4 recruiting

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  • Canisius-Wilhelmina Ziekenhuis

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South Africa4 sites, 4 recruiting

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  • Wilgers Oncology Centre

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Denmark2 sites, 2 recruiting

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    Odense, Region Syddanmark, 5000

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Slovakia2 sites

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Sweden1 site, 1 recruiting

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About this study

Official title: 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.

Read the 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.

Being tested
PF-06821497, Placebo, Enzalutamide
Keywords
MEVROMETOSTAT, METASTATIC CASTRATION RESISTANT PROSTATE CANCER, PF-06821497, EZH2, enhancer of zeste homologue-2, enzalutamide, mCRPC, Prostrate Cancer, castrate resistant prostate cancer, prostatecancer-study.com, efficacy, safety, pharmacokinetics, pharmacodynamics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06821497Drug

    Also called Mevrometostat

    Oral continuous

  • PlaceboDrug

    Oral continuous

  • EnzalutamideDrug

    Also called Xtandi

    Oral continuous

Study groups in NCT06629779
Study groupRoleWhat they receive
Arm AExperimentalParticipants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
Receives: Drug: PF-06821497; Drug: Enzalutamide
Arm BActive comparatorParticipants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
Receives: Drug: Placebo; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Randomization up to approximately 3 years

Secondary outcomes (20)

  1. Overall survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Randomization up to approximately 5 years

  2. 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

    Measured: Randomization up to approximately 5 years

  3. 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

    Measured: Randomization up to approximately 3 years

  4. 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.

    Measured: Randomization up to approximately 3 years.

  5. 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.

    Measured: Randomization up to approximately 3 years

  6. Prostate Specific Antigen Response

    Proportion of participants with PSA response ≥50% in participants with detectable PSA values at baseline.

    Measured: Randomization up to approximately 3 years.

  7. Time to initiation of antineoplastic therapy.

    Time from randomization to first use of new antineoplastic therapy.

    Measured: Randomization up to approximately 5 years.

  8. Time to initiation of cytotoxic chemotherapy.

    Time from randomization to first use of new cytotoxic chemotherapy.

    Measured: Randomization up to approximately 5 years

  9. 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).

    Measured: Randomization up to approximately 3 years.

  10. 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.

    Measured: Randomization up to approximately 5 years

  11. 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.

    Measured: Randomization up to approximately 5 years

  12. To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden.

    Evaluation of ctDNA burden at baseline and on study.

    Measured: Baseline up to approximately 3 years.

  13. 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

    Measured: Cycle 1 Day 15 to last PK draw at Cycle 6 Day 1 (cycle length is 28 days)

  14. 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.

    Measured: Randomization up to approximately 5 years

  15. 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.

    Measured: Randomization up to Week 25

  16. 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.

    Measured: Randomization up to approximately 5 years

  17. 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."

    Measured: Randomization up to approximately 5 years

  18. 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.

    Measured: Randomization up to approximately 5 years

  19. 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.

    Measured: Randomization to approximately 5 years

  20. 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

    Measured: Randomization up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start22 Oct 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06629779
Sponsor's protocol ID
C2321003
Other IDs
2024-511652-40-00
Status last verified
Oct 2026
First submitted
10 Sep 2024
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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;22(12):1397-1408. doi: 10.1080/14796694.2026.2667441. Epub 2026 May 10.

    PubMed 42108644

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-06821497 and Enzalutamide in people with Metastatic Castration-Resistant Prostate Cancer, run by Pfizer at 231 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 231 sites in United States, China, Brazil, Japan, France and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression Free Survival (rPFS) (time frame: Randomization up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06629779, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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