C2321008 - Mevrometostat use in Men With Metastatic Castration-Sensitive Prostate Cancer
Research type
Research Study
Full title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF EVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)
IRAS ID
1012012
Contact name
Jennifer Hill
Contact email
Sponsor organisation
Pfizer Inc.
ISRCTN Number
/
Clinicaltrials.gov Identifier
/
Research summary
Participants are invited to join this study funded by Pfizer. The study focuses on metastatic castration-sensitive prostate cancer (mCSPC). Participants in the study have not had prior treatment with novel hormonal therapy or chemotherapy for mCSPC.
The study aims to understand the safety and effects of a drug called mevrometostat (PF-06821497) combined with enzalutamide. Mevrometostat is designed to inhibit a protein called EZH2, while enzalutamide is already approved to treat mCSPC. Researchers want to see if the combination of both drugs works better than enzalutamide alone. Mevrometostat is an investigational drug, meaning it is not approved for use in this country.
Researchers will compare the combination of mevrometostat and enzalutamide to a placebo and enzalutamide. The placebo looks like mevrometostat but contains no active ingredients. This study will not replace your regular medical care, but you may have extra doctor visits, procedures, and tests.
Approximately 1000 people will be recruited to participate in this study, which will occur at about 250 sites in 25 countries. If enrolled, participants will visit the research site every 4 weeks until Week 53, then every 8 weeks while receiving the study drug(s), and every 12 weeks during follow-up. The length of your involvement depends on how long you take the study drug(s).
Participants will be randomly assigned to receive either mevrometostat and enzalutamide or a placebo and enzalutamide. This is a double-blind study, meaning neither you nor the study team will know if you are receiving mevrometostat or the placebo.
The study drugs must be taken daily, with specific instructions on timing and handling missed doses. If you have any
questions or concerns, the study team is available to help.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0727
Date of REC Opinion
16 Oct 2025
REC opinion
Further Information Favourable Opinion