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

Description

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.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Study Overview

Study Details

Study overview

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.

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

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

Condition
Metastatic Castration-Resistant Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Tucson

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

Tucson

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

Lisle

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

Omaha

Adult & Pediatric Urology, PC, Omaha, Nebraska, United States, 68114

Myrtle Beach

AUC Urologists, LLC, Myrtle Beach, South Carolina, United States, 29572

Myrtle Beach

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

Myrtle Beach

Grand Strand Medical Center, Myrtle Beach, South Carolina, United States, 29572

Myrtle Beach

Parkway Surgery Center, Myrtle Beach, South Carolina, United States, 29572

San Antonio

USA Clinical Trials, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  • * Surgically or medically castrated, with serum testosterone ≤50 ng/dL (≤1.73 nmol/L) at screening.
  • * 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.
  • * Prior to randomization, there must be resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1.
  • * ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.
  • * 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 mCRPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents and. Docetaxel treatment is allowed for mCSPC.
  • * Previous administration with an investigational product (drug or vaccine) within 30 days.
  • * 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).
  • * Major surgery or palliative localized radiation therapy within 14 days before randomization.
  • * Inadequate organ function.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2028-11-30