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).
Launched by PFIZER · Aug 9, 2024
Trial Information
Current as of October 02, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called MEVPRO-1, is looking at a new medicine called PF-06821497 (Mevrometostat) to see if it can help men with metastatic castrate-resistant prostate cancer (mCRPC) who have previously been treated with another medication called abiraterone acetate. In this study, researchers want to find out if combining PF-06821497 with another drug, enzalutamide, is safer and more effective than just using enzalutamide alone or another treatment called docetaxel (a type of chemotherapy). The main goal is to see how long patients can live without their cancer getting worse when using this combination treatment.
To be eligible for this trial, participants need to be men aged 65 and older with confirmed prostate cancer that has spread to other parts of the body. They should also be experiencing disease progression despite being on hormone therapy. However, those with certain health conditions, such as significant heart disease or previous treatments for prostate cancer with specific drugs, cannot participate. If someone joins the trial, they can expect regular check-ups and monitoring to see how well the treatment is working and to ensure their safety throughout the study.
Gender
MALE
Eligibility criteria
- 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 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.
- • Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
- • Inadequate organ function.
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported