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 and have not yet received chemotherapy in the
mCSPC setting.
Additional locations may be listed on ClinicalTrials.gov for NCT07028853.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationPfizer Inc