Last updated 9 days ago
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
900 patients around the world
Available in Brazil, Argentina
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
combination with enzalutamide.
Pfizer
3Research sites
900Patients around the world
This study is for people with
Prostate cancer
Castration resistant prostate cancer
Requirements for the patient
From 18 Years
Male
Medical requirements
- Male participants aged ≥18 years at screening.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.Surgically or medically castrated, with serum testosterone ≤50 ng/dL at screening.Progressive disease in the setting of medical or surgical castration.Prior to randomization, there must be resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1.ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.
- Any medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.Clinically significant cardiovascular disease.Known or suspected brain metastasis or active leptomeningeal disease.Participants must be treatment naïve at the mCRPC stage.Previous administration with an investigational product within 30 days.Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers.Major surgery or palliative localized radiation therapy within 14 days before randomization.Inadequate organ function.
Sites
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Recruiting
Hospital Privado de Córdoba
Recruiting
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
StudyMEVPRO-2
SponsorPfizer
Study typeInterventional
Conditions
Castration resistant prostate cancer
Requirements
From 18 YearsMale
Unique study IDclinicaltrials.gov
NCT06629779
