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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2025

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At a glance

  • Drugs Opevesostat (Primary) ; Abiraterone acetate; Dexamethasone; Enzalutamide; Fludrocortisone; Hydrocortisone; Hydrocortisone; Prednisone
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OMAHA-003; OMAHA1
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 23 Sep 2025 2 efficacy primary end-points are removed.
  • 23 Sep 2025 Planned number of patients changed from 1253 to 1310.
  • 23 Sep 2025 Status changed from active, no longer recruiting to recruiting.

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