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

RecruitingPhase 3

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

Who can join

Ages 18 and older · Men

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 900 · Started: Oct 22, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06629779

Locations in the U.S.

ArizonaIronwood Cancer & Research Centers, Chandler
Ironwood Cancer & Research Centers, Gilbert
Ironwood Cancer & Research Centers, Glendale
Palo Verde Hematology Oncology, Glendale
Ironwood Cancer & Research Centers, Goodyear
Ironwood Cancer & Research Centers, Mesa
Ironwood Cancer & Research Centers, Mesa
Ironwood Cancer & Research Centers, Phoenix
Ironwood Cancer & Research Centers, Scottsdale
ArkansasHighlands Oncology, Fayetteville
Arkansas Urology - Little Rock, Little Rock
Highlands Oncology, Rogers
Highlands Oncology Group, Springdale
CaliforniaLos Angeles Cancer Network (LACN), Anaheim
Los Angeles Cancer Network (LACN), Fountain Valley
Los Angeles Cancer Network (LACN), Glendale
Los Angeles Cancer Network (LACN), Glendale
Los Angeles Cancer Network (LACN), Laguna Hills
Los Angeles Cancer Network (LACN), Los Angeles
Los Angeles Cancer Network (LACN), Los Angeles
Medical Oncology Associates of San Diego, San Diego
IllinoisBlessing Hospital, Quincy
Blessing Physician Services, Quincy
NebraskaAdult & Pediatric Urology, PC, Omaha
New MexicoCHRISTUS St. Vincent Regional Cancer Center, Santa Fe
New YorkMontefiore Medical Center, The Bronx
Montefiore Medical Center - Medical Park, The Bronx
South CarolinaAUC Urologists, LLC, Myrtle Beach
Carolina Urologic Research Center, LLC, Myrtle Beach
Grand Strand Medical Center, Myrtle Beach
Parkway Surgery Center, Myrtle Beach
TexasUSA Clinical Trials, San Antonio
WashingtonNorthwest Medical Specialties, PLLC, Bonney Lake
Northwest Medical Specialties, PLLC, Federal Way
Northwest Medical Specialties, PLLC, Gig Harbor
Northwest Medical Specialties, PLLC, Puyallup
Fred Hutchinson Cancer Center, Seattle
Harborview Medical Center, Seattle
University of Washington Medical Center - Montlake, Seattle
Northwest Medical Specialties, PLLC, Tacoma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.