OncRef

Clinical Trial: NCT06136624

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

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-10-06

Study Overview

Brief 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.

Official Title

A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)

Conditions

Prostate Cancer Metastatic

Intervention / Treatment

  • Drug: Opevesostat
  • Drug: Abiraterone acetate
  • Drug: Enzalutamide
  • Drug: Hydrocortisone
  • Drug: Fludrocortisone acetate
  • Drug: Prednisone
  • Drug: Dexamethasone

Other Study ID Numbers

  • 5684-003
  • 2023-504899-25-00
  • MK-5684-003
  • jRCT2031240029
  • U1111-1287-5304
  • 2023

Start Date (Actual)

2023-12-31

Primary Completion Date (Estimated)

2028-08-02

Study Completion Date (Estimated)

2030-02-15

Enrollment (Estimated)

1310

Study Type

Interventional

Phase

Phase 3