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)
NCT06136650 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1314
Last updated 2026-05-18
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.
Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Prostatic Neoplasms
Interventions
- DRUG
-
Opevesostat
Administered orally
- DRUG
-
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
-
Administered orally
Sponsors & Collaborators
-
Orion Corporation, Orion Pharma
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-18
- Primary Completion
- 2028-05-10
- Completion
- 2030-12-02
- FDA Drug
- Yes
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
Study Locations
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