A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT06629779

This Phase 3 study evaluates PF-06821497 with enzalutamide versus placebo with enzalutamide in mCRPC patients. Eligible males must have confirmed adenocarcinoma, metastatic disease, and be castrated with progressive disease. Participants are randomized 1:1 to receive either the investigational drug or placebo, both with enzalutamide, following a structured trial phase sequence.

Patient Parameters

Program Overview

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

Description

This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting.

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) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Eligibility Criteria

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 disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  • Surgically or medically castrated, with serum testosterone ≤50 ng/dL (≤1.73 nmol/L) at screening.
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  • Progressive disease in the setting of medical or surgical castration.
  • Prior to randomization, there must be resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1.
  • ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.

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 mCRPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents and. Docetaxel treatment 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).
  • Major surgery or palliative localized radiation therapy within 14 days before randomization.
  • Inadequate organ function.

Locations

FACILITYZIPCITYSTATE
Arizona Urology Specialists (East Side Location)85715TucsonArizona
Arizona Urology Specialists (AUS)-Orange Grove85741TucsonArizona
Highlands Oncology72703FayettevilleArkansas
Highlands Oncology72758RogersArkansas
Highlands Oncology Group72762SpringdaleArkansas
Duly Health and Care (Bone Scintigraphy)60532LisleIllinois
NextStage Clinical Research-Chicago-(04)60532LisleIllinois
Duly Health and Care (CT and MRI)60559WestmontIllinois
Adult & Pediatric Urology, PC68114OmahaNebraska
AUC Urologists, LLC29572Myrtle BeachSouth Carolina

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