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Clinical Trials List

Protocol NumberC2321008
NCT Number(ClinicalTrials.gov Identfier)NCT07028853
Not yet recruiting

2025-08-01 - 2035-08-31

Phase III

Recruiting6

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Cheng-Che Chen Division of Urology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Jung Su Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsiao-Jen Chung Division of Urology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHUNG-HSIN CHEN Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shu-Pin Huang Division of Urology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Castration Sensitive Prostate Cancer (mCSPC)

Objectives

This Phase 3 randomized trial (C2321008, hereinafter referred to as MEVPRO-3) aims to demonstrate that mevrometostat + enzalutamide provides superior clinical benefit to mCSPC participants compared with placebo + enzalutamide.

Test Drug

Tablets
Capsules

Active Ingredient

Mevrometostat (PF-06821497)
Enzalutamide

Dosage Form

110
130

Dosage

125 mg
40 mg

Endpoints

BICR assessed rPFS according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (soft tissue diseases) and the Prostate Cancer Working Group 3 (PCWG3) (bone diseases).

Inclution Criteria

Inclusion Criteria

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 Criteria

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    1000 participants