A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT06551324

This trial evaluates the safety and efficacy of PF-06821497 with enzalutamide versus enzalutamide or docetaxel in mCRPC patients post-abiraterone. Eligible participants have confirmed adenocarcinoma, metastatic disease, and progressive disease under castration. Interventions include PF-06821497 (875 mg BID), docetaxel (75 mg/m2 IV every 21 days), and enzalutamide (160 mg QD).

Patient Parameters

Program Overview

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment.

The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.

Eligibility Criteria

Inclusion Criteria

  • 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.
  • Progressive disease in the setting of surgical or medical castration.
  • Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 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 make the participant. inappropriate for the study.

  • Clinically significant cardiovascular disease.

  • Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.

  • Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment. with the following exceptions:

    1. Treatment with first-generation antiandrogen agents, if discontinued prior to randomization
    2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
  • Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).

  • Inadequate organ function.

Locations

FACILITYZIPCITYSTATE
Arizona Urology Specialists- Provide ICF for Review Only85715TucsonArizona
Arizona Urology Specialists (AUS)-Orange Grove85741TucsonArizona
Colorado Clinical Research80228LakewoodColorado
Duly Health and Care60521HinsdaleIllinois
Duly Health And Care60532LisleIllinois
NextStage Clinical Research-Chicago-(04)60532LisleIllinois
Duly Health and Care60559WestmontIllinois
AtlantiCare08234Egg Harbor TownshipNew Jersey
Salisbury VA Medical Center28144SalisburyNorth Carolina
Keystone Urology Specialists17604LancasterPennsylvania

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