drugset / Trial / NCT06136624
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-12-31
- Primary completion
- 2028-08-02
- Completion
- 2030-02-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Comparator | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Subject | Opevesostat | Small molecule | 5 mg | Oral |
| Background | Dexamethasone | Small molecule | 1.5 mg | Oral |
| Background | Fludrocortisone | Other / unclassified | 0.1 mg | Oral |
| Background | Hydrocortisone | Other / unclassified | 100 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 5 mg | Oral |