Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

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.

Trial Details

NCT ID
NCT06136624
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Opevesostat
  • Abiraterone acetate
  • Enzalutamide
  • Hydrocortisone
  • Fludrocortisone acetate
  • Prednisone
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311
  • Palo Alto, California, United States|37.44188,-122.14302
  • Riverside, California, United States|33.95335,-117.39616
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Highlands Ranch, Colorado, United States|39.55388,-104.96943

Key Eligibility Criteria

  • Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
  • Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
  • Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by comput…
  • Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)

For full eligibility, visit ClinicalTrials.gov.

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