RecruitingPhase 3NCT07028853
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)
Sponsor
Pfizer
Enrollment
1,000 participants
Start Date
Sep 28, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria5
- Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
- Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease).
- Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).
- Participants must have ECOG PS 0 or 1.
Exclusion Criteria7
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Clinically significant cardiovascular disease.
- Known or suspected brain metastasis or active leptomeningeal disease.
- Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.
- Previous administration with an investigational product (drug or vaccine) within 30 days.
- Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study).
- Inadequate organ function.
Interventions
DRUGMevrometostat
Oral continuous
DRUGPlacebo
Oral continuous
DRUGEnzalutamide
Oral continuous
Locations(188)
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NCT07028853
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