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)

Active:	Yes
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT06136650
Trial Phases:	Phase III	Protocol IDs:	5684-004 (primary) NCI-2024-01655 2023-504957-11 jRCT2031240030 MK-5684-004 U1111-1288-5002
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Merck Sharp and Dohme LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT06136650

Summary

The purpose of this study is to assess the efficacy and safety of opevesostat plus
hormone replacement therapy (HRT) 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
hypotheses are that opevesostat is superior to alternative abiraterone acetate or
enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate
Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST
1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS),
in androgen receptor ligand binding domain (AR LBD) mutation positive and negative
participants.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

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