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)

Nancy Knowles Cancer Center - Elmhurst

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.

Sponsor: Merck Sharp & Dohme

https://clinicaltrials.gov/ct2/show/record/NCT06136650

Inclusion criteria includes:

• Have confirmed adenocarcinoma of the prostate without small cell histology
• Has current evidence of metastatic disease
• Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
• Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
• Has adequate organ function

Exclusion Criteria includes:

• Has presence of gastrointestinal condition
• Is unable to swallow capsules/tablets
• Has poorly controlled diabetes mellitus
• Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
• History or family history of long QTc syndrome
• Has a history of seizure(s) within 6 months prior or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
• Has received a taxane-based chemotherapy and or NHA for metastatic castration-resistant prostate cancer (mCRPC)
• Has received prior treatment with radium for prostate cancer
• Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
• Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
• Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
• Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Active infection requiring systemic therapy

Approx. 7 years