A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)
Pfizer
Summary
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
Description
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1. This study consists of a Screening Phase, Randomization, T…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria * Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening. * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease). * Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement). * Participants must…
Interventions
- DrugMevrometostat
Oral continuous
- DrugPlacebo
Oral continuous
- DrugEnzalutamide
Oral continuous
Locations (341)
- Clearview Cancer Institute (Crestwood)Huntsville, Alabama
- Clearview Cancer InstituteHuntsville, Alabama
- Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersChandler, Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersGilbert, Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersGlendale, Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersGoodyear, Arizona