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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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 →Frequently asked questions
Is NCT06353386 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy, radiotherapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages