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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.
Trial Status: active
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.
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
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.
Additional locations may be listed on ClinicalTrials.gov for NCT07028853.
Locations matching your search criteria
United States
New York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available
Utah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not Available
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)