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 4067927, Alabama 4829764 35209

Ironwood Cancer & Research Centers
Chandler 5289282, Arizona 5551752 85224

Ironwood Cancer & Research Centers
Gilbert 5295903, Arizona 5551752 85297

Ironwood Cancer & Research Centers
Glendale 5295985, Arizona 5551752 85306

Ironwood Cancer & Research Centers
Mesa 5304391, Arizona 5551752 85202

Ironwood Cancer & Research Centers
Mesa 5304391, Arizona 5551752 85206

Ironwood Cancer & Research Centers
Phoenix 5308655, Arizona 5551752 85028

Ironwood Cancer & Research Centers
Scottsdale 5313457, Arizona 5551752 85260

Los Angeles Cancer Network
Anaheim 5323810, California 5332921 92801

UCSF Cancer Center Berkeley
Berkeley 5327684, California 5332921 94702

UCSF Cancer Center Burlingame
Burlingame 5331920, California 5332921 94010

Los Angeles Cancer Network
Fountain Valley 5350207, California 5332921 92708

Los Angeles Cancer Network
Glendale 5352423, California 5332921 91204

Los Angeles Cancer Network
Glendale 5352423, California 5332921 91206

Los Angeles Cancer Network
Los Angeles 5368361, California 5332921 90017

Los Angeles Cancer Network
Los Angeles 5368361, California 5332921 90067

Stanford Cancer Center
Palo Alto 5380748, California 5332921 94305

UCSF Investigational Drug Pharmacy
San Francisco 5391959, California 5332921 94158

UCSF Medical Center at Mission Bay
San Francisco 5391959, California 5332921 94158

UCSF Cancer Center San Mateo
San Mateo 5392423, California 5332921 94402

Sutter Santa Rosa
Santa Rosa 5393287, California 5332921 95403

Stanford Health Care Attention: Investigational Pharmacy
Stanford 5398563, California 5332921 94305

Colorado Clinical Research
Lakewood 5427946, Colorado 5417618 80228

University of Miami Sylvester Comprehensive Cancer Center - Aventura
Aventura 4146429, Florida 4155751 33180

Florida Cancer Specialists
Bonita Springs 4148533, Florida 4155751 34135

Florida Cancer Specialists
Bradenton 4148708, Florida 4155751 34211

Florida Cancer Specialists
Cape Coral 4149962, Florida 4155751 33909

University of Miami Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables 4151871, Florida 4155751 33146

University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach
Deerfield Beach 4153071, Florida 4155751 33442

University of Miami Hospital and Clinics - Doral
Doral 4153471, Florida 4155751 33166

Florida Cancer Specialists
Fort Myers 4155995, Florida 4155751 33905

Florida Cancer Specialists
Fort Myers 4155995, Florida 4155751 33908

University of Miami Sylvester Comprehensive Cancer Center - Kendall
Kendall 4160711, Florida 4155751 33176

University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami 4164138, Florida 4155751 33136

University of Miami Hospital and Clinics, UHealth Tower
Miami 4164138, Florida 4155751 33136

University of Miami Sylvester Comprehensive Cancer Center - Griffin Cancer Research Building
Miami 4164138, Florida 4155751 33136

Florida Cancer Specialists
N. Venice, Florida 4155751 34275

Florida Cancer Specialists
Naples 4165565, Florida 4155751 34102

AdventHealth Hematology and Oncology
Orlando 4167147, Florida 4155751 32804

AdventHealth Orlando Infusion Center
Orlando 4167147, Florida 4155751 32804

University of Miami Sylvester Comprehensive Cancer Center - Plantation
Plantation 4168782, Florida 4155751 33324

Florida Cancer Specialists
Port Charlotte 4169130, Florida 4155751 33980

Florida Cancer Specialists
Sarasota 4172131, Florida 4155751 34236

Duly Health and Care
Lisle 4900080, Illinois 4896861 60532

NextStage Clinical Research-Chicago-(04)
Lisle 4900080, Illinois 4896861 60532

Duly Health and Care
Westmont 4916207, Illinois 4896861 60559

The University of Louisville, James Graham Brown Cancer Center
Louisville 4299276, Kentucky 6254925 40202

University of Louisville Hospital
Louisville 4299276, Kentucky 6254925 40202

UofL Health Medical Center Northeast
Louisville 4299276, Kentucky 6254925 40245

New England Cancer Specialists
Topsham 4980927, Maine 4971068 04086

New England Cancer Specialists
Westbrook 4982753, Maine 4971068 04092

VA St. Louis Health Care System
St Louis 4407066, Missouri 4398678 63106

AtlantiCare
Egg Harbor 8766331, New Jersey 5101760 08234

Circuit Clinical /Crystal Run Healthcare LLP
Middletown 5126842, New York 5128638 10941

Circuit Clinical
Middletown 5126842, New York 5128638 10941

Crystal Run Healthcare
Monroe 5127302, New York 5128638 10950

James J. Peters VA Medical Center
The Bronx 5110266, New York 5128638 10468

Salisbury VA Medical Center
Salisbury 4489985, North Carolina 4482348 28144

The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists
Lancaster 5197079, Pennsylvania 6254927 17604

AUC Urologists, LLC
Myrtle Beach 4588718, South Carolina 4597040 29572

Carolina Urologic Research Center, LLC
Myrtle Beach 4588718, South Carolina 4597040 29572

Grand Strand Medical Center
Myrtle Beach 4588718, South Carolina 4597040 29572

Parkway Surgery Center
Myrtle Beach 4588718, South Carolina 4597040 29572

Sarah Cannon Research Institute, LLC
Nashville 4644585, Tennessee 4662168 37203

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

USA Clinical Trials
San Antonio 4726206, Texas 4736286 78229

Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112

Harborview Medical Center
Seattle 5809844, Washington 5815135 98104

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109

University of Washington Medical Center - Montlake
Seattle 5809844, Washington 5815135 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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

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Vanderbilt University Medical Center