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RECRUITING

NCT06629779

PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2024-10-22

Completion Date

2028-11-30

Last Updated

2026-10-30

Healthy Volunteers

Conditions

Metastatic Castration-Resistant Prostate Cancer

Interventions

DRUG

PF-06821497

Oral continuous

DRUG

Placebo

Oral continuous

DRUG

Enzalutamide

Oral continuous

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.