Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Status:
Recruiting
Trial end date:
2028-08-02
Target enrollment:
Participant gender:
Summary
This is a phase 3, randomized, open-label study of opevesostat compared to alternative
abiraterone acetate or enzalutamide in participants with metastatic castration-resistant
prostate cancer (mCRPC) with respect to overall survival (OS) and to radiographic
progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response
Evaluation Criteria In Solid Tumors (RECIST 1.1) as assessed by blinded independent central
review (BICR) in participants with mCRPC previously treated with next-generation hormonal
agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior
with respect to OS and rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in androgen
receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.