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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Metastatic Castration-Resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06629779

Run by

Pfizer

People needed

900

Starts

2024-10-22

Expected to finish

2028-11-30

Last updated by the study team

2026-07-29

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 medical or surgical castration.
• ECOG performance status 0 or 1, with a life expectancy of ≥12 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 in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.
• Known 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.
• Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
• Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, 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:
• Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
• 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 (drug or vaccine) 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 — Gilbert, Arizona, United States (enrolling)
• Palo Verde Hematology Oncology — Glendale, Arizona, United States (enrolling)
• Ironwood Cancer & Research Centers — Glendale, Arizona, United States (enrolling)
• Ironwood Cancer & Research Centers — Goodyear, Arizona, United States (enrolling)
• Ironwood Cancer & Research Centers — Mesa, Arizona, United States (enrolling)
• Ironwood Cancer & Research Centers — Mesa, Arizona, United States (enrolling)
• Ironwood Cancer & Research Centers — Phoenix, Arizona, United States (enrolling)
• Ironwood Cancer & Research Centers — Scottsdale, Arizona, United States (enrolling)
• Highlands Oncology — Fayetteville, Arkansas, United States (enrolling)
• Arkansas Urology - Little Rock — Little Rock, Arkansas, United States (enrolling)
• Highlands Oncology — Rogers, Arkansas, United States (enrolling)
• Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
• Los Angeles Cancer Network (LACN) — Anaheim, California, United States (enrolling)
• Los Angeles Cancer Network (LACN) — Fountain Valley, California, United States (enrolling)
• Los Angeles Cancer Network (LACN) — Glendale, California, United States (enrolling)
• Los Angeles Cancer Network (LACN) — Glendale, California, United States (enrolling)
• Los Angeles Cancer Network (LACN) — Laguna Hills, California, United States (enrolling)
• Los Angeles Cancer Network (LACN) — Los Angeles, California, United States (enrolling)
• Los Angeles Cancer Network (LACN) — Los Angeles, California, United States (enrolling)
• Medical Oncology Associates of San Diego — San Diego, California, United States (enrolling)
• Accellacare of Duly — Lisle, Illinois, United States (enrolling)
• Duly Health and Care (Bone Scintigraphy) — Lisle, Illinois, United States (enrolling)
• Blessing Hospital — Quincy, Illinois, United States (enrolling)
• Blessing Physician Services — Quincy, Illinois, United States (enrolling)
• Ironwood Cancer & Research Centers — Chandler, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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