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Clinical Trials in the UK / NCT06551324
Active, not recruiting Phase 3

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).

NCT06551324 · tracked via the Priya Life Science UK tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2024-10-21
Last updated
2026-08-11

Condition(s) studied

Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Investigational drug(s) / intervention(s)

PF-06821497DocetaxelEnzalutamide

PF-06821497: 875 mg BID (2 times a day)

Docetaxel: 75 mg/m2 IV (every 21 days)

Enzalutamide: 160 mg QD

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
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, CDK4/6 inhibitors, 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. 3. Use of 5-alpha reductase inhibitors within 28 days of randomization. * Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer). * Inadequate organ function.

Primary outcome measure(s)

Trial sites (224)

FacilityCityRegionStatus
Urology Centers of Alabama Homewood Alabama
Ironwood Cancer & Research Centers Chandler Arizona
Ironwood Cancer & Research Centers Gilbert Arizona
Ironwood Cancer & Research Centers Glendale Arizona
Ironwood Cancer & Research Centers Mesa Arizona
Ironwood Cancer & Research Centers Mesa Arizona
Ironwood Cancer & Research Centers Phoenix Arizona
Ironwood Cancer & Research Centers Scottsdale Arizona
Los Angeles Cancer Network Anaheim California
UCSF Cancer Center Berkeley Berkeley California
UCSF Cancer Center Burlingame Burlingame California
Los Angeles Cancer Network Fountain Valley California
Los Angeles Cancer Network Glendale California
Los Angeles Cancer Network Glendale California
Los Angeles Cancer Network Los Angeles California
Los Angeles Cancer Network Los Angeles California
Stanford Cancer Center Palo Alto California
UCSF Investigational Drug Pharmacy San Francisco California
UCSF Medical Center at Mission Bay San Francisco California
UCSF Cancer Center San Mateo San Mateo California
Sutter Santa Rosa Santa Rosa California
Stanford Health Care Attention: Investigational Pharmacy Stanford California
Colorado Clinical Research Lakewood Colorado
University of Miami Sylvester Comprehensive Cancer Center - Aventura Aventura Florida
Florida Cancer Specialists Bradenton Florida
Florida Cancer Specialists Cape Coral Florida
University of Miami Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center Coral Gables Florida
University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach Deerfield Beach Florida
University of Miami Hospital and Clinics - Doral Doral Florida
Florida Cancer Specialists Fort Myers Florida
Florida Cancer Specialists Fort Myers Florida
University of Miami Sylvester Comprehensive Cancer Center - Kendall Kendall Florida
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida
University of Miami Hospital and Clinics, UHealth Tower Miami Florida
University of Miami Sylvester Comprehensive Cancer Center - Griffin Cancer Research Building Miami Florida
Florida Cancer Specialists N. Venice Florida
Florida Cancer Specialists Naples Florida
AdventHealth Hematology and Oncology Orlando Florida
AdventHealth Orlando Infusion Center Orlando Florida
University of Miami Sylvester Comprehensive Cancer Center - Plantation Plantation Florida

+ 184 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06551324 on ClinicalTrials.gov ↗ ← All trials in the UK