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

Purpose

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.

Condition

  • Metastatic Castration-Resistant Prostate Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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 medical or surgical castration. - 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 make the participant inappropriate for the study. - Known 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. - Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions. - Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, 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 (ADT) agents; 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 (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer). - 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 PF-06821497 or matching placebo in a blinded fashion, as indicated in Section 6.1. 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 PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
  • Drug: PF-06821497
    Oral continuous
    Other names:
    • Mevrometostat
  • 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

Palo Verde Hematology Oncology
Glendale, Arizona 85304

Ironwood Cancer & Research Centers
Glendale, Arizona 85306

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

Arizona Urology Specialists (East Side Location)
Tucson, Arizona 85715

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

Adventist Health Physicians Network
Hidden Valley Lake, California 95467

Adventist Health Physicians Network
Napa, California 94558

Adventist Health St. Helena
Saint Helena, California 94574

Duly Health and Care (Bone Scintigraphy)
Lisle, Illinois 60532

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

Blessing Hospital
Quincy, Illinois 62301

Blessing Physician Services
Quincy, Illinois 62301

Duly Health and Care (CT and MRI)
Westmont, Illinois 60559

AUC Urologists, LLC
Myrtle Beach, South Carolina 29572

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

Grand Strand Medical Center
Myrtle Beach, South Carolina 29572

Parkway Surgery Center
Myrtle Beach, South Carolina 29572

More Details

NCT ID
NCT06629779
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 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.

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Vanderbilt University Medical Center