A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)

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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. 21, 2024

Planned enrollment: 600

Trial ID: NCT06551324
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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)

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Goal: Evaluate whether adding the EZH2 inhibitor mervometostat (PF-06821497) to enzalutamide improves radiographic progression-free survival compared with physician’s choice of enzalutamide or docetaxel in mCRPC after progression on abiraterone.

Patients: Adults with histologically or cytologically confirmed prostatic adenocarcinoma (no small cell features) and metastatic disease (bone and/or soft tissue) who have progressed in the castration setting after abiraterone in mCSPC or first-line mCRPC. ECOG 0–2 and life expectancy ≥6 months required. Key exclusions include prior ARSi beyond first-generation antiandrogens, prior PARP monotherapy, prior chemotherapy for prostate cancer except docetaxel in mCSPC without progression during or ≤3 months after completion, prior radioligand therapy, active CNS disease or seizures, significant cardiovascular disease, active inflammatory GI disease, and inadequate organ function.

Design: Phase 3, randomized, open-label, multicenter study enrolling approximately 600 participants. Allocation is randomized between the investigational combination and physician’s choice control. Primary purpose is treatment, with blinded independent central review for radiographic endpoints.

Treatments: Arm A: Mervometostat (PF-06821497) 875 mg orally twice daily plus enzalutamide 160 mg once daily. Mervometostat is a potent, selective EZH2 inhibitor that reduces H3K27 methylation and reactivates silenced genes, targeting PRC2-mediated epigenetic repression; it shows marked selectivity for EZH2 over EZH1. Early-phase studies in mCRPC, including combination with enzalutamide, demonstrated manageable safety, a median rPFS of approximately 17 months, and objective responses in measurable disease, supporting Phase 3 evaluation. Arm B: Physician’s choice of enzalutamide 160 mg once daily or docetaxel 75 mg/m2 IV every 21 days, both standard-of-care options post-abiraterone in mCRPC.

Outcomes: Primary: Radiographic progression-free survival by BICR per RECIST v1.1/PCWG3 or death. Key secondary endpoints include overall survival; objective response rate and duration of response in measurable soft tissue disease; PSA outcomes (time to PSA progression and PSA50 response); time to initiation of subsequent antineoplastic therapy; time to first symptomatic skeletal event; safety and tolerability (CTCAE v5.0); patient-reported outcomes including pain (BPI-SF), HRQoL (FACT-P total and domain scores), EQ-5D-5L, PRO-CTCAE, and FACT-GP5; time to definitive/confirmatory deterioration in pain and HRQoL; pharmacokinetics of PF-06821497 with enzalutamide; and ctDNA burden at baseline and on treatment.

Burden on patient: Moderate. Both arms require ongoing androgen deprivation and standard imaging for rPFS assessment similar to usual mCRPC practice. The investigational arm adds twice-daily oral mervometostat and scheduled pharmacokinetic blood draws through at least cycle 6, increasing visit time and venipuncture frequency. All participants undergo periodic CT/MRI, bone scans, PSA assessments, safety labs, and comprehensive PRO questionnaires throughout follow-up, plus optional or protocol-specified ctDNA sampling. Patients randomized to docetaxel have added infusion visits every 3 weeks and chemotherapy-related monitoring, which increases travel and clinic time compared with oral therapy. Overall procedures are consistent with a phase 3 oncology trial, with added PK and PRO schedules and, for some, IV chemotherapy contributing to the moderate burden.

Last updated: Oct 2025

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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

Chandler, Arizona, 85224, 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

Glendale, Arizona, 85306, 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

Mesa, Arizona, 85206, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network

Los Angeles, California, 90067, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network

Los Angeles, California, 90017, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network

Glendale, California, 91206, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network

Glendale, California, 91204, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network

Fountain Valley, California, 92708, United States

No email / No phone

Status: Recruiting

Los Angeles Cancer Network

Anaheim, California, 92801, United States

No email / No phone

Status: Recruiting

Stanford Cancer Center

Palo Alto, California, 94305, United States

No email / No phone

Status: Recruiting

Stanford Health Care Attention: Investigational Pharmacy

Stanford, California, 94305, United States

No email / No phone

Status: Recruiting

Sutter Santa Rosa

Santa Rosa, California, 95403, United States

No email / No phone

Status: Recruiting

UCSF Cancer Center Berkeley

Berkeley, California, 94702, United States

No email / No phone

Status: Recruiting

UCSF Cancer Center Burlingame

Burlingame, California, 94010, United States

No email / No phone

Status: Recruiting

UCSF Cancer Center San Mateo

San Mateo, California, 94402, United States

No email / No phone

Status: Recruiting

UCSF Investigational Drug Pharmacy

San Francisco, California, 94158, United States

No email / No phone

Status: Recruiting

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

No email / No phone

Status: Recruiting

Colorado Clinical Research

Lakewood, Colorado, 80228, United States

No email / No phone

Status: Recruiting

AdventHealth Hematology and Oncology

Orlando, Florida, 32804, United States

No email / No phone

Status: Recruiting

AdventHealth Orlando Infusion Center

Orlando, Florida, 32804, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Sarasota, Florida, 34236, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Port Charlotte, Florida, 33980, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Naples, Florida, 34102, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

N. Venice, Florida, 34275, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Fort Myers, Florida, 33908, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Fort Myers, Florida, 33905, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Cape Coral, Florida, 33909, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Bradenton, Florida, 34211, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Bonita Springs, Florida, 34135, United States

No email / No phone

Status: Recruiting

University of Miami Hospital and Clinics - Doral

Doral, Florida, 33166, United States

No email / No phone

Status: Recruiting

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, 33136, United States

No email / No phone

Status: Recruiting

University of Miami Hospital and Clinics, UHealth Tower

Miami, Florida, 33136, United States

No email / No phone

Status: Recruiting

University of Miami Sylvester Comprehensive Cancer Center - Aventura

Aventura, Florida, 33180, United States

No email / No phone

Status: Recruiting

University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach

Deerfield Beach, Florida, 33442, United States

No email / No phone

Status: Recruiting

University of Miami Sylvester Comprehensive Cancer Center - Griffin Cancer Research Building

Miami, Florida, 33136, United States

No email / No phone

Status: Recruiting

University of Miami Sylvester Comprehensive Cancer Center - Kendall

Kendall, Florida, 33176, United States

No email / No phone

Status: Recruiting

University of Miami Sylvester Comprehensive Cancer Center - Plantation

Plantation, Florida, 33324, United States

No email / No phone

Status: Recruiting

University of Miami Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Coral Gables, Florida, 33146, United States

No email / No phone

Status: Recruiting

Duly Health And Care

Lisle, Illinois, 60532, United States

No email / No phone

Status: Recruiting

Duly Health and Care

Hinsdale, Illinois, 60521, United States

No email / No phone

Status: Recruiting

Duly Health and Care

Westmont, Illinois, 60559, United States

No email / No phone

Status: Recruiting

NextStage Clinical Research-Chicago-(04)

Lisle, Illinois, 60532, United States

No email / No phone

Status: Recruiting

The University of Louisville, James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

No email / No phone

Status: Recruiting

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

No email / No phone

Status: Recruiting

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245, United States

No email / No phone

Status: Recruiting

New England Cancer Specialists

Topsham, Maine, 04086, United States

No email / No phone

Status: Recruiting

New England Cancer Specialists

Westbrook, Maine, 04092, United States

No email / No phone

Status: Recruiting

VA St. Louis Health Care System

St Louis, Missouri, 63106, United States

No email / No phone

Status: Recruiting

AtlantiCare

Egg Harbor, New Jersey, 08234, United States

No email / No phone

Status: Recruiting

Circuit Clinical

Middletown, New York, 10941, United States

No email / No phone

Status: Recruiting

Circuit Clinical /Crystal Run Healthcare LLP

Middletown, New York, 10941, United States

No email / No phone

Status: Recruiting

Crystal Run Healthcare

Monroe, New York, 10950, United States

No email / No phone

Status: Recruiting

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

No email / No phone

Status: Recruiting

Salisbury VA Medical Center

Salisbury, North Carolina, 28144, United States

No email / No phone

Status: Recruiting

The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists

Lancaster, Pennsylvania, 17604, 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

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

USA Clinical Trials

San Antonio, Texas, 78229, United States

No email / No phone

Status: Recruiting

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, 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

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

No email / No phone

Status: Recruiting

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

No email / No phone

Status: Not yet recruiting

Houston Methodist Baytown Hospital

Baytown, Texas, 77521, United States

No email / No phone

Status: Not yet recruiting

Houston Methodist Clear Lake Hospital

Houston, Texas, 77058, United States

No email / No phone

Status: Not yet recruiting

Houston Methodist Cypress Hospital

Cypress, Texas, 77429, United States

No email / No phone

Status: Not yet recruiting

Houston Methodist Hospital

Houston, Texas, 77030, United States

No email / No phone

Status: Not yet recruiting

Houston Methodist Hospital Infusion

Houston, Texas, 77030, United States

No email / No phone

Status: Not yet recruiting

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, 77479, United States

No email / No phone

Status: Not yet recruiting

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, 77385, United States

No email / No phone

Status: Not yet recruiting

Houston Methodist West Hospital

Houston, Texas, 77094, United States

No email / No phone

Status: Not yet recruiting

Houston Methodist Willowbrook Hospital

Houston, Texas, 77070, United States

No email / No phone

Status: Not yet recruiting

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