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A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Trial Status: active
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.
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 medical or surgical castration.
ECOG performance status 0 or 1, with a life expectancy of ≥12 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 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;
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06629779.
Locations matching your search criteria
United States
New York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not Available
This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497
(mevrometostat) in combination with enzalutamide versus placebo in combination with
enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have
been initiated after documentation of mCRPC with the exception of ADT (androgen
deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any
of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not
permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting.
This study consists of a Screening Phase, Randomization, Treatment Phase, Safety
Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to
receive (Arm A) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in
