Trials / Recruiting
RecruitingNCT06136624
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
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
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,310 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Opevesostat | Administered orally |
| DRUG | Abiraterone acetate | Administered orally |
| DRUG | Enzalutamide | Administered orally |
| DRUG | Hydrocortisone | Administered orally or IM as a rescue medication |
| DRUG | Fludrocortisone acetate | Administered orally |
| DRUG | Prednisone | Administered orally |
| DRUG | Dexamethasone | Administered orally as rescue medication |
Timeline
- Start date
- 2023-12-31
- Primary completion
- 2028-08-02
- Completion
- 2028-08-02
- First posted
- 2023-11-18
- Last updated
- 2026-04-08
Locations
282 sites across 36 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Puerto Rico, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06136624. Inclusion in this directory is not an endorsement.