NCT06136650

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)

MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,314 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) 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.

Detailed description

Per Protocol Amendment 08, overall survival (OS) was moved to be a secondary outcome measure.

Conditions

• Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Opevesostat	Administered orally
DRUG	Dexamethasone	Administered orally
DRUG	Fludrocortisone acetate	Administered orally
DRUG	Hydrocortisone	Administered orally or IM as a rescue drug
DRUG	Abiraterone acetate	Administered orally
DRUG	Prednisone acetate	Administered orally
DRUG	Enzalutamide	Administered orally

Timeline

• Start date: 2023-12-18
• Primary completion: 2028-05-10
• Completion: 2030-12-02
• First posted: 2023-11-18
• Last updated: 2026-04-15

Locations

323 sites across 39 countries: United States, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czechia, Estonia, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Peru, Portugal, Puerto Rico, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study