Status:
RECRUITING
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.
Lead Sponsor:
Pfizer
Conditions:
Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Hormone Sensitive Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 ar...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2034
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07028853
Start Date
September 28 2025
End Date
December 8 2034
Last Update
March 4 2026
Active Locations (188)
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1
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
2
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States, 85297
3
Ironwood Cancer & Research Centers
Glendale, Arizona, United States, 85306
4
Ironwood Cancer & Research Centers
Goodyear, Arizona, United States, 85395