West Cancer Center

PROSTATE: METASTATIC: CASTRATE SENSITIVE: 1st Line: MEVPRO-3

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

Title

Pfizer C2321008 Prostate MEVPRO-3

Study Title

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

Site Link

NCT07028853

Malignancy

Prostate, CSPC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line

Investigational Agent

enzalutamide +/- mevrometostat

Drug Class

EZH2 inhibitor

Brad Somer, MD

Sponsor

Pfizer

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Adenocarcinoma of the prostate without small cell features
Metastatic disease documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI (for soft tissue/visceral disease)
Resolution of acute effects of any prior therapy
ECOG PS 0-1
No known or suspected CNS disease
Must be treatment naive at the mCSPC stage
- However, treatment with a first-generation antiandrogen is allowed
No investigational products within 30 days
Adequate organ function

Objective

Primary
- Radiographic PFS
Secondary
- OS
- ORR in soft tissue
- DOR in soft tissue
- PSA response
- Time to PSA progression
- Time to initiation of antineoplastic therapy
- Time to first symptomatic skeletal event
- Time from randomization to CRPC
- PK
- PRO
- ctDNA

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes