Prostate CancerOpen to EnrollmentPhase 3

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)

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Study snapshot

Title: Pfizer C2321008 Prostate MEVPRO-3
Malignancy: Prostate, CSPC
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: 1st Line
Investigational agent: enzalutamide +/- mevrometostat
Drug class: EZH2 inhibitor
Principal investigator: Brad Somer, MD
Sponsor: Pfizer
Path: Adenocarcinoma
Randomized: Yes
ClinicalTrials.gov ID: NCT07028853

Eligibility and objectives

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

Treatment details