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
This observational or N/A phase trial investigates Cancer of the Prostate and Hormone Sensitive Prostate Cancer and is currently actively recruiting participants. Pfizer leads this study, which shows 10 recorded versions since 2025 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
10 versions recorded-
Apr 28, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE3
▶ Show 5 earlier versions
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Oct 2025 — Nov 2025 [monthly]
Not Yet Recruiting PHASE3
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Sep 2025 — Oct 2025 [monthly]
Not Yet Recruiting PHASE3
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Aug 2025 — Sep 2025 [monthly]
Not Yet Recruiting PHASE3
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Jul 2025 — Aug 2025 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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.
Contact Information
- Pfizer
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aalst, Belgium , Alhambra, United States , Anderlecht, Belgium , Angers, France , Ankara, Turkey (Türkiye) , Ankara, Turkey (Türkiye) , Ankara, Turkey (Türkiye) , Atascadero, United States , Athens, Greece , Athens, Greece and 285 more locations