OncoMatch/Clinical Trials/NCT06353386
Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
Is NCT06353386 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for prostatic neoplasms, castration-resistant.
Treatment: Opevesostat · Olaparib · Docetaxel · Cabazitaxel · Fludrocortisone acetate · Dexamethasone · Prednisone — Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Prior therapy
Must have received: androgen deprivation therapy
Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
Must have received: novel hormonal agent — non-metastatic or metastatic, hormone-sensitive or castration-resistant prostate cancer
Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
Cannot have received: systemic anticancer therapy
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Cannot have received: radiotherapy
Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCSD Moores Cancer Center ( Site 0039) · La Jolla, California
- UCLA Hematology/Oncology - Santa Monica ( Site 0044) · Los Angeles, California
- University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051) · Miami, Florida
- University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049) · Baltimore, Maryland
- Rutgers Cancer Institute of New Jersey ( Site 0033) · New Brunswick, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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