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).

Purpose

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.

Condition

  • Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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 with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required. - 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. - Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery. - 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 (i.e. 177Lu-PSMA-617, radium 223), 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 first dose of study intervention. 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)
  • Drug: PF-06821497
    875 mg BID (2 times a day)
    Other names:
    • Mevrometostat
  • Drug: Enzalutamide
    160 mg QD
    Other names:
    • XTANDI
Active Comparator
Arm B 		Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days
  • Drug: Docetaxel
    75 mg/m2 IV (every 21 days)
    Other names:
    • Taxotere
  • Drug: Enzalutamide
    160 mg QD
    Other names:
    • XTANDI

Recruiting Locations

Urology Centers of Alabama
Homewood, Alabama 35209

Arizona Urology Specialists- Provide ICF for Review Only
Tucson, Arizona 85715

Arizona Urology Specialists (AUS)-Orange Grove
Tucson, Arizona 85741

Sutter Santa Rosa
Santa Rosa, California 95403

Colorado Clinical Research
Lakewood, Colorado 80228

Florida Cancer Specialists
Bonita Springs, Florida 34135

Florida Cancer Specialists
Bradenton, Florida 34211

Florida Cancer Specialists
Cape Coral, Florida 33909

Florida Cancer Specialists
Fort Myers, Florida 33905

Florida Cancer Specialists
Fort Myers, Florida 33908

Florida Cancer Specialists
Naples, Florida 34102

Florida Cancer Specialists
Port Charlotte, Florida 33980

Florida Cancer Specialists
Sarasota, Florida 34236

Florida Cancer Specialists
Venice, Florida 34292

Duly Health and Care
Hinsdale, Illinois 60521

Duly Health And Care
Lisle, Illinois 60532

NextStage Clinical Research-Chicago-(04)
Lisle, Illinois 60532

Duly Health and Care
Westmont, Illinois 60559

New England Cancer Specialists
Topsham, Maine 04086

New England Cancer Specialists
Westbrook, Maine 04092

AtlantiCare
Egg Harbor Township, New Jersey 08234

Keystone Urology Specialists
Lancaster, Pennsylvania 17604

SCRI Oncology Partners
Nashville, Tennessee 37203

USA Clinical Trials
San Antonio, Texas 78229

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Harborview Medical Center
Seattle, Washington 98104

Fred Hutchinson Cancer Center
Seattle, Washington 98109

University of Washington Medical Center - Montlake
Seattle, Washington 98195

More Details

NCT ID
NCT06551324
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

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Vanderbilt University Medical Center