Clinical Trial

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Study acronym: OMAHA-003
Recruiting Phase 3
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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) 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 in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.
Protocol Amendment History 1 change
minor Completion pushed: 2028-08-02 -> 2030-02-15 2026-05-06
Trial Details
NCT Number NCT06136624
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Prostate Cancer Metastatic
Enrollment 1,310 participants
Start Date 2023-12-31
Primary Completion 2028-08-02 (estimated)
Study Completion 2030-02-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-24