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)

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.

Eligibility

Age range

Not specified

Sex

All

Healthy volunteers

No

Interventions

• 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

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