RECRUITING

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).

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)

Quick Facts

Study Start:2024-10-21
Study Completion:2028-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06551324

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
  2. * Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  3. * Progressive disease in the setting of surgical or medical castration.
  4. * Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
  1. * 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.
  2. * Clinically significant cardiovascular disease.
  3. * Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
  4. * Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy, 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:
  5. 1. Treatment with first-generation antiandrogen agents, if discontinued prior to randomization
  6. 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.
  7. * Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
  8. * Inadequate organ function.

Contacts and Locations

Study Contact

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

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

NextStage Clinical Research-Chicago-(04)
Lisle, Illinois, 60532
United States
Duly Health and Care
Westmont, Illinois, 60559
United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604
United States
Baptist M&S Imaging (Medical Center)
San Antonio, Texas, 78229
United States
USA Clinical Trials
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-21
Study Completion Date2028-10-29

Study Record Updates

Study Start Date2024-10-21
Study Completion Date2028-10-29

Terms related to this study

Keywords Provided by Researchers

  • Prostate cancer
  • Enhancer of zeste homolog 2
  • castrate resistant prostate cancer
  • Hormone resistant
  • Metastatic hormone resistant prostate cancer
  • Metastatic castrate resistant prostate cancer
  • PF-06821497
  • Enzalutamide
  • Docetaxel
  • Advanced prostate cancer
  • Efficacy
  • Safety
  • Open-label
  • Relapsed
  • refractory

Additional Relevant MeSH Terms

  • Metastatic Castrate Resistant Prostate Cancer (mCRPC)