A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect 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 androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

NCT Number	NCT06136650
Lead Sponsor	Merck Sharp & Dohme LLC
Conditions	Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms
Enrollment	1,314 participants
Start Date	2023-12-18
Primary Completion	2028-05-10 (estimated)
Study Completion	2030-12-02 (estimated)
Updated on ClinicalTrials.gov	2026-08-13