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 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 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), in androgen receptor ligand
binding domain (AR LBD) mutation positive and negative participants.

Objectives

Per Protocol Amendment 08, overall survival (OS) was moved to be a secondary outcome
measure.

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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