Clinical Trials | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (Pf-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (Mevpro-3)

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Metastatic Castration Sensitive Prostate Cancer for a research study. The purpose of the study is to evaluate whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in the same disease setting. In this study, mevrometostat in combination with enzalutamide is being compared to placebo in combination with enzalutamide. Approximately 1000 participants will be randomly assigned on a 1:1 basis to: • Investigational Arm A: Mevrometostat 875 mg BID + enzalutamide 160 mg QD • Comparator Arm B: Placebo BID + enzalutamide 160 mg QD This study will require you to visit the study doctor every 4 weeks until Week 53, and then every 8 weeks while you are receiving study drug(s), and then every 12 weeks during follow up. You will be asked to undergo study procedures and to provide information about your health. These procedures will include blood tests, health questionnaires and radiographic imaging for disease assessment. Radiographic imaging will be done every 8 weeks until Week 25, then every 12 weeks while on study. Your time in the study will depend on how long you take the study drug(s) and have follow up visits.