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)

The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids 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 overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Trial Details

NCT ID
NCT06136650
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Opevesostat
  • Dexamethasone
  • Fludrocortisone acetate
  • Hydrocortisone
  • Abiraterone acetate
  • Prednisone acetate
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Irvine, California, United States|33.66946,-117.82311
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • Palo Alto, California, United States|37.44188,-122.14302

Key Eligibility Criteria

  • The main inclusion criteria include but are not limited to the following:
  • Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
  • Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (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 shown by …

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Prostate Cancer Trials on Trialify →