Last updated 22 days ago

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.

1000 patients around the world
Available in United States, Argentina
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 participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1. This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.
Pfizer
1Research sites
1000Patients around the world

This study is for people with

Prostate cancer
Castration sensitive prostate cancer

Requirements for the patient

From 18 Years
Male

Medical requirements

Male participants aged ≥18 years at screening.
Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
Metastatic prostate cancer documented by positive bone scan or metastatic lesion(s) on CT or MRI.
Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1.
Participants must have ECOG PS 0 or 1.
Any medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation.
Clinically significant cardiovascular disease.
Known or suspected brain metastasis or active leptomeningeal disease.
Participants must be treatment naïve at the mCSPC stage.
Previous administration with an investigational product within 30 days.
Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers.
Inadequate organ function.

Sites

Centro de Investigación Pergamino S.A
Centro de Investigación Pergamino S.A
Av. de Mayo 1115, Pergamino, Buenos Aires
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