Print

Purpose

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.

Conditions

Eligibility

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

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. - Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization. - Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization - 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is a double-blind study. Participants will receive mevrometostat or matching placebo in a blinded fashion. Participants, investigators and site staff, and sponsor staff will be aware that participants in both study arms are receiving enzalutamide. Enzalutamide will be provided in an open-label manner to participants in each treatment arm. Participants and their caregivers will be blinded to their assigned study intervention. Investigators and other site staff will be blinded to participants' assigned study intervention Sponsor staff will be blinded to participants' assigned study intervention, except for sponsor staff involved in the assignment or distribution of study intervention.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
  • Drug: Mevrometostat
    Oral continuous
    Other names:
    • PF-06821497
  • Drug: Enzalutamide
    Oral continuous
    Other names:
    • Xtandi
Active Comparator
Arm B 		Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
  • Drug: Placebo
    Oral continuous
  • Drug: Enzalutamide
    Oral continuous
    Other names:
    • Xtandi

Recruiting Locations

Ironwood Cancer & Research Centers
Chandler, Arizona 85224

Ironwood Cancer & Research Centers
Gilbert, Arizona 85297

Ironwood Cancer & Research Centers
Glendale, Arizona 85306

Ironwood Cancer & Research Centers
Goodyear, Arizona 85395

Ironwood Cancer & Research Centers
Mesa, Arizona 85202

Ironwood Cancer & Research Centers
Mesa, Arizona 85206

Ironwood Cancer & Research Centers
Phoenix, Arizona 85028

Ironwood Cancer & Research Centers
Scottsdale, Arizona 85260

Highlands Oncology Group, PA
Fayetteville, Arkansas 72703

Highlands Oncology Group, PA
Rogers, Arkansas 72758

Highlands Oncology Group, PA
Springdale, Arkansas 72762

UCLA Hematology/Oncology - Alhambra
Alhambra, California 91801

UCLA Hematology/Oncology - Atascadero
Atascadero, California 93422

Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location)
Beverly Hills, California 90211

Cedars-Sinai Cancer Beverly Hills
Beverly Hills, California 90211

UCLA Hematology/Oncology - Beverly Hills
Beverly Hills, California 90212

UCLA Hematology/Oncology - Burbank
Burbank, California 91505

UCLA Hematology/Oncology - Encino
Encino, California 91436

UCLA Hematology/Oncology - Irvine
Irvine, California 92604

UCLA Hematology/Oncology - Laguna Hills
Laguna Hills, California 92653

Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California 90048

Ronald Reagan UCLA Medical Center - Drug Information Center
Los Angeles, California 90095

UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California 90095

UCLA Hematology/Oncology
Los Angeles, California 90095

UCLA Hematology/Oncology - Marina del Rey
Marina del Rey, California 90292

UCLA Hematology/Oncology - Pasadena
Pasadena, California 91105

UCLA Hematology/Oncology - Porter Ranch
Porter Ranch, California 91326

UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California 93401

UCLA Hematology/Oncology - Santa Barbara
Santa Barbara, California 93101

UCLA Hematology/Oncology- Santa Monica
Santa Monica, California 90404

UCLA Hematology/Oncology - Torrance
Torrance, California 90505

UCLA Hematology/Oncology - Santa Clarita
Valencia, California 91355

UCLA Hematology/Oncology - Ventura
Ventura, California 93003

UCLA Hematology/Oncology - Westlake
Westlake Village, California 91361

AdventHealth Medical Group Urology of Denver
Denver, Colorado 80210

Cancer Care Specialists of Illinois
Decatur, Illinois 62526

Cancer Care Specialists of Illinois
O'Fallon, Illinois 62269

University of Rochester Medical Center
Rochester, New York 14642

University of Rochester, Cancer Center Pharmacy (Investigational Product)
Rochester, New York 14642

Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York 10461

Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York 10461

University Hospitals Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011

TriState Urologic Services PSC Inc. dba The Urology Group
Cincinnati, Ohio 45212

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

University Hospitals Seidman Cancer Center at UH Mentor Health Center
Mentor, Ohio 44060

UH Minoff Health Center at Chagrin Highlands
Orange, Ohio 44122

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

Grand Strand Medical Center
Myrtle Beach, South Carolina 295724607

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

Parkway Surgery Center
Myrtle Beach, South Carolina 29572

The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee 38138

Urology Associates, P.C.
Nashville, Tennessee 37209

University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas 75235

University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
Dallas, Texas 75235

University of Texas Southwestern Simmons Cancer Center - Redbird
Dallas, Texas 75237

University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
Dallas, Texas 75390

University of Texas Southwestern Medical Center
Dallas, Texas 75390

University of Texas Southwestern Simmons Cancer Center - Fort Worth
Fort Worth, Texas 76104

US Oncology Investigational Product Center (IPC)
Irving, Texas 75063

University of Texas Southwestern Simmons Cancer Center - Richardson/Plano
Richardson, Texas 75080

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Blue Ridge Cancer Care
Blacksburg, Virginia 24060

Blue Ridge Cancer Care
Low Moor, Virginia 24457

Blue Ridge Cancer Care
Roanoke, Virginia 24014

Blue Ridge Cancer Care
Salem, Virginia 24153

Blue Ridge Cancer Care
Wytheville, Virginia 24382

Northwest Medical Specialties, PLLC
Bonney Lake, Washington 98391

Northwest Medical Specialties, PLLC
Federal Way, Washington 98003

Northwest Medical Specialties, PLLC
Gig Harbor, Washington 98332

Northwest Medical Specialties, PLLC
Puyallup, Washington 98373

Northwest Medical Specialties, PLLC
Tacoma, Washington 98405

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718

University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792

More Details

NCT ID
NCT07028853
Status
Recruiting
Sponsor
Pfizer

Study Contact

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

Detailed Description

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) placebo in combination with enzalutamide.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center