NCT07028853

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1. This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Conditions

• Metastatic Castration Sensitive Prostate Cancer (mCSPC)
• Hormone Sensitive Prostate Cancer
• Prostate Cancer
• Cancer of the Prostate

Interventions

Type	Name	Description
DRUG	Mevrometostat	Oral continuous
DRUG	Placebo	Oral continuous
DRUG	Enzalutamide	Oral continuous

Timeline

• Start date: 2025-09-28
• Primary completion: 2028-09-12
• Completion: 2034-12-08
• First posted: 2025-06-19
• Last updated: 2026-03-30

Locations

253 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Finland, France, Germany, Greece, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Slovakia, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study