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

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Pfizer (industry)

Phase: 3

Start date: Oct. 22, 2024

Planned enrollment: 900

Trial ID: NCT06629779
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: Mervometostat (EZH2i, PF-06821497)

TrialFetch AI Analysis

Goal: Determine whether adding mevrometostat to enzalutamide improves outcomes compared with enzalutamide alone in metastatic castration-resistant prostate cancer (mCRPC).

Patients: Patients with progressive, metastatic prostate adenocarcinoma despite medical or surgical castration, ECOG performance status 0–1, and an expected survival of at least 12 months. Patients must not have received systemic anticancer treatment for mCRPC or prior enzalutamide, apalutamide, darolutamide, or abiraterone in any setting. Prior docetaxel for castration-sensitive disease is permitted under specified conditions.

Design: Global, multicenter, double-blind, placebo-controlled trial with 1:1 randomization, followed by safety and long-term follow-up.

Treatments: Patients receive oral mevrometostat 875 mg twice daily plus enzalutamide 160 mg once daily, or matching placebo twice daily plus enzalutamide 160 mg once daily. Mevrometostat is an investigational EZH2 inhibitor that reduces histone H3K27 methylation, a mechanism involved in gene-expression regulation. In a small randomized phase 1 study in previously treated mCRPC, median radiographic progression-free survival was 14.3 months with the combination versus 6.2 months with enzalutamide alone; these preliminary findings do not establish benefit in this trial’s treatment-naïve population. Enzalutamide is an androgen receptor inhibitor used to treat mCRPC.

Outcomes: The primary endpoint is radiographic progression-free survival, assessed by blinded independent central review using RECIST v1.1 for soft tissue and PCWG3 criteria for bone. Secondary measures include overall survival, pain progression, response duration, PSA outcomes, time to subsequent treatment or chemotherapy, symptomatic skeletal events, progression on next-line therapy, adverse events, circulating tumor DNA, drug concentrations, and patient-reported pain, symptoms, and quality of life.

Burden on patient: The expected burden is moderate. Treatment is oral, but patients will need regular visits for imaging, safety assessments, blood sampling for circulating tumor DNA and selected pharmacokinetic measurements, and questionnaires. Follow-up may continue for up to approximately five years. The visit and scan schedule is not specified, so travel frequency cannot be estimated precisely; no mandatory biopsy is described.

Last updated: Sep 2026

Eligibility More information

Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.

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Córdoba, Córdoba Province, 5016, Argentina

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Sofia, 1797, Bulgaria

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Turku, Southwest Finland, 20520, Finland

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Hamburg, 20246, Germany

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Studienpraxis Urologie

Nürtingen, Baden-Wurttemberg, 72622, Germany

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Tübingen, Baden-Wurttemberg, 72076, Germany

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Chaïdári, Attikí, 124 62, Greece

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Larissa, Thessalía, 411 10, Greece

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Terni, 05100, Italy

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Milan, 20132, Italy

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Meldola, Emilia-Romagna, 47014, Italy

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Rome, Lazio, 00144, Italy

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Kumamoto, 860-0008, Japan

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Fukuoka, 811-1395, Japan

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Osaka, 541-8567, Japan

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Yamagata, 990-9585, Japan

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Kashiwa, Chiba, 277-8577, Japan

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Matsuyama, Ehime, 791-0280, Japan

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Sapporo, Hokkaido, 060-8648, Japan

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Kobe, Hyōgo, 650-0017, Japan

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Kanazawa, Ishikawa-ken, 920-8641, Japan

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Yokohama, Kanagawa, 232-0024, Japan

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Yokosuka, Kanagawa, 238-8558, Japan

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Shinjuku-ku, Tokyo, 1608582, Japan

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Nijmegen, Gelderland, 6532 SZ, Netherlands

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Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

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Schiedam, South Holland, 3118 JH, Netherlands

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Auckland, 1023, New Zealand

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Tauranga, Bay of Plenty, 3112, New Zealand

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Christchurch, Canterbury, 8011, New Zealand

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Hamilton, Waikato Region, 3204, New Zealand

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Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

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Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300, Poland

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Krakow, Lesser Poland Voivodeship, 30-348, Poland

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Krakow, Lesser Poland Voivodeship, 31-826, Poland

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Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

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Clinical Best Solutions

Lublin, Lublin Voivodeship, 20-011, Poland

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Koszalin, West Pomeranian Voivodeship, 75-581, Poland

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Provita Profamilia

Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland

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CUIMED, s.r.o., Urologicka ambulancia

Bratislava, 851 05, Slovakia

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Trenčín, 911 01, Slovakia

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Univerzitna nemocnica Martin

Martin, 036 59, Slovakia

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Cancercare Langenhoven Drive Oncology Centre

Port Elizabeth, Eastern Cape, 6045, South Africa

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Wilgers Oncology Centre

Pretoria, Gauteng, 0081, South Africa

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Wits Clinical Research

Soweto, Gauteng, 2013, South Africa

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George, Western Cape, 6529, South Africa

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Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo, 58128, South Korea

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National Cancer Center

Goyang-si, Kyǒnggi-do, 10408, South Korea

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Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea

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Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

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Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

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Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

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Kyungpook National University Chilgok Hospital

Daegu, Taegu-kwangyǒkshi, 41404, South Korea

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Chungnam national university hospital

Junggu, Taejǒn-kwangyǒkshi, 35015, South Korea

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Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

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Madrid, 28050, Spain

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

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Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

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Valencia, Valenciana, Comunitat, 46009, Spain

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Stockholm, Stockholms LÄN [se-01], 11883, Sweden

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

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National Cheng Kung University Hospital

Tainan, 704, Taiwan

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Status: Recruiting

National Taiwan University Hospital

Taipei, 10002, Taiwan

No email / No phone

Status: Recruiting

Taichung Veterans General Hospital

Taichung, 407, Taiwan

No email / No phone

Status: Recruiting

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

No email / No phone

Status: Recruiting

Ankara University Health Practice and Research Hospitals

Ankara, 06620, Turkey (Türkiye)

No email / No phone

Status: Recruiting

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

No email / No phone

Status: Recruiting

Sbü Gülhane Eğitim Ve Araştirma Hastanesi

Ankara, 06010, Turkey (Türkiye)

No email / No phone

Status: Recruiting

Koç Üniversitesi Hastanesi

Istanbul, İ̇stanbul, 34010, Turkey (Türkiye)

No email / No phone

Status: Recruiting

Marmara Universitesi Pendik Egitim Arastirma Hastanesi

Istanbul, İ̇stanbul, 34899, Turkey (Türkiye)

No email / No phone

Status: Recruiting

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

Istanbul, İ̇stanbul, 34722, Turkey (Türkiye)

No email / No phone

Status: Recruiting

I.E.U. Medical Point Hastanesi

Izmir, İ̇zmir, 009035575, Turkey (Türkiye)

No email / No phone

Status: Recruiting

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

No email / No phone

Status: Recruiting

Royal Blackburn Hospital

Blackburn, Blackburn WITH Darwen, BB2 3HH, United Kingdom

No email / No phone

Status: Recruiting

Mid and South Essex NHS Foundation Trust

Chelmsford, Essex, CM1 7ET, United Kingdom

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Scottsdale, Arizona, 85260, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Phoenix, Arizona, 85028, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Mesa, Arizona, 85206, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Mesa, Arizona, 85202, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Goodyear, Arizona, 85395, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Glendale, Arizona, 85306, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Gilbert, Arizona, 85297, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

No email / No phone

Status: Recruiting

Palo Verde Hematology Oncology

Glendale, Arizona, 85304, United States

No email / No phone

Status: Recruiting

Arkansas Urology - Little Rock

Little Rock, Arkansas, 72211, United States

No email / No phone

Status: Recruiting

Highlands Oncology

Rogers, Arkansas, 72758, United States

No email / No phone

Status: Recruiting

Highlands Oncology

Fayetteville, Arkansas, 72703, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

No email / No phone

Status: Recruiting

Adventist Health Physicians Network

Hidden Valley Lake, California, 95467, United States

No email / No phone

Status: Recruiting

Adventist Health Physicians Network

Napa, California, 94558, United States

No email / No phone

Status: Recruiting

Adventist Health St. Helena

St. Helena, California, 94574, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network (LACN)

Glendale, California, 91206, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network (LACN)

Los Angeles, California, 90017, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network (LACN)

Los Angeles, California, 90067, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network (LACN)

Anaheim, California, 92801, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network (LACN)

Fountain Valley, California, 92708, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network (LACN)

Glendale, California, 91204, United States

No email / No phone

Status: Recruiting

Accellacare of Duly

Lisle, Illinois, 60532, United States

No email / No phone

Status: Recruiting

Blessing Hospital

Quincy, Illinois, 62301, United States

No email / No phone

Status: Recruiting

Blessing Physician Services

Quincy, Illinois, 62301, United States

No email / No phone

Status: Recruiting

Duly Health and Care (Bone Scintigraphy)

Lisle, Illinois, 60532, United States

No email / No phone

Status: Recruiting

Duly Health and Care (CT and MRI)

Westmont, Illinois, 60559, United States

No email / No phone

Status: Recruiting

Adult & Pediatric Urology, PC

Omaha, Nebraska, 68114, United States

No email / No phone

Status: Recruiting

CHRISTUS St. Vincent Regional Cancer Center

Santa Fe, New Mexico, 87505, United States

No email / No phone

Status: Recruiting

Montefiore Medical Center

The Bronx, New York, 10467, United States

No email / No phone

Status: Recruiting

Montefiore Medical Center - Medical Park

The Bronx, New York, 10461, United States

No email / No phone

Status: Recruiting

Salisbury VA Medical Center

Salisbury, North Carolina, 28144, United States

No email / No phone

Status: Recruiting

AUC Urologists, LLC

Myrtle Beach, South Carolina, 29572, United States

No email / No phone

Status: Recruiting

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

No email / No phone

Status: Recruiting

Grand Strand Medical Center

Myrtle Beach, South Carolina, 29572, United States

No email / No phone

Status: Recruiting

Parkway Surgery Center

Myrtle Beach, South Carolina, 29572, United States

No email / No phone

Status: Recruiting

USA Clinical Trials

San Antonio, Texas, 78229, United States

No email / No phone

Status: Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

No email / No phone

Status: Recruiting

Harborview Medical Center

Seattle, Washington, 98104, United States

No email / No phone

Status: Recruiting

Northwest Medical Specialties, PLLC

Puyallup, Washington, 98373, United States

No email / No phone

Status: Recruiting

Northwest Medical Specialties, PLLC

Gig Harbor, Washington, 98332, United States

No email / No phone

Status: Recruiting

Northwest Medical Specialties, PLLC

Federal Way, Washington, 98003, United States

No email / No phone

Status: Recruiting

Northwest Medical Specialties, PLLC

Bonney Lake, Washington, 98391, United States

No email / No phone

Status: Recruiting

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

No email / No phone

Status: Recruiting

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

No email / No phone

Status: Recruiting

Clinica Amo - Rio Vermelho

Salvador, Estado de Bahia, 41950-640, Brazil

No email / No phone

Status: Not yet recruiting

Hospital Da Bahia

Salvador, Estado de Bahia, 41810-011, Brazil

No email / No phone

Status: Not yet recruiting

IC La Serena Research

La Serena, Coquimbo Region, 1720430, Chile

No email / No phone

Status: Not yet recruiting

Oncocentro Apys

Viña del Mar, Región de Valparaíso, 2520598, Chile

No email / No phone

Status: Not yet recruiting

FALP

Santiago, Santiago Metropolitan, 7500921, Chile

No email / No phone

Status: Not yet recruiting

Fundacion Arturo Lopez Perez

Providencia, Santiago Metropolitan, 7500966, Chile

No email / No phone

Status: Not yet recruiting

Fundación Arturo López Pérez

Providencia, Santiago Metropolitan, 7500836, Chile

No email / No phone

Status: Not yet recruiting

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

No email / No phone

Status: Not yet recruiting

Krajská nemocnice Liberec

Liberec, 460 63, Czechia

No email / No phone

Status: Not yet recruiting

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

No email / No phone

Status: Not yet recruiting

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

No email / No phone

Status: Not yet recruiting

Medical Oncology Associates of San Diego

San Diego, California, 92123, United States

No email / No phone

Status: Not yet recruiting

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