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).
Running, not enrolling · Phase 3
Conditions studied: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
In brief
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.
Key facts
- Study ID
- NCT06551324
- Run by
- Pfizer
- People needed
- 600
- Starts
- 2024-10-21
- Expected to finish
- 2028-10-29
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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:
- Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
- 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.
- 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.
Where it is running
- Ironwood Cancer & Research Centers — Chandler, Arizona, United States
- Ironwood Cancer & Research Centers — Gilbert, Arizona, United States
- Ironwood Cancer & Research Centers — Glendale, Arizona, United States
- Ironwood Cancer & Research Centers — Mesa, Arizona, United States
- Ironwood Cancer & Research Centers — Mesa, Arizona, United States
- Ironwood Cancer & Research Centers — Phoenix, Arizona, United States
- Ironwood Cancer & Research Centers — Scottsdale, Arizona, United States
- Los Angeles Cancer Network — Anaheim, California, United States
- UCSF Cancer Center Berkeley — Berkeley, California, United States
- UCSF Cancer Center Burlingame — Burlingame, California, United States
- Los Angeles Cancer Network — Fountain Valley, California, United States
- Los Angeles Cancer Network — Glendale, California, United States
- Los Angeles Cancer Network — Glendale, California, United States
- Los Angeles Cancer Network — Los Angeles, California, United States
- Los Angeles Cancer Network — Los Angeles, California, United States
- Stanford Cancer Center — Palo Alto, California, United States
- UCSF Investigational Drug Pharmacy — San Francisco, California, United States
- UCSF Medical Center at Mission Bay — San Francisco, California, United States
- UCSF Cancer Center San Mateo — San Mateo, California, United States
- Sutter Santa Rosa — Santa Rosa, California, United States
- Stanford Health Care Attention: Investigational Pharmacy — Stanford, California, United States
- Colorado Clinical Research — Lakewood, Colorado, United States
- University of Miami Sylvester Comprehensive Cancer Center - Aventura — Aventura, Florida, United States
- Florida Cancer Specialists — Bonita Springs, Florida, United States
- Urology Centers of Alabama — Homewood, Alabama, United States
Full record on ClinicalTrials.gov
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