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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)
NCT06353386 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Olaparib
- DRUG Cabazitaxel
- DRUG Opevesostat
- DRUG Fludrocortisone acetate
Study Locations (20)
Quebec
- Centre Hospitalier de l'Université de Montréal ( Site 0200) — Montreal
- Jewish General Hospital ( Site 0206) — Montreal
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207) — Québec
Region M. de Santiago
- FALP ( Site 0301) — Santiago
- Pontificia Universidad Catolica de Chile ( Site 0303) — Santiago
- Bradfordhill ( Site 0300) — Santiago
California
- UCSD Moores Cancer Center ( Site 0039) — La Jolla
- UCLA Hematology/Oncology - Santa Monica ( Site 0044) — Los Angeles
Bogota D.C.
- FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406) — Bogotá
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402) — Bogotá
Florida
- University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051) — Miami
Maryland
- University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049) — Baltimore
New Jersey
- Rutgers Cancer Institute of New Jersey ( Site 0033) — New Brunswick
Ohio
- University Hospitals Cleveland Medical Center ( Site 0043) — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2024-05-20 |
| Est. Completion | 2029-01-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06353386
The ClinicalTrials.gov registry entry for NCT06353386 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prostatic Neoplasms, Castration-Resistant appearing as the primary indexed condition, and to 5 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06353386 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Quebec, Region M. de Santiago, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06353386 about?
NCT06353386 is a clinical study titled "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)". 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 combinati...
What is the current status of trial NCT06353386?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2024-05-20. Estimated completion is 2029-01-15.
What conditions does trial NCT06353386 study?
This clinical trial studies the following conditions: Prostatic Neoplasms, Castration-Resistant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06353386?
The interventions under investigation include: Docetaxel (DRUG), Olaparib (DRUG), Cabazitaxel (DRUG), Opevesostat (DRUG), Fludrocortisone acetate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06353386?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06353386 being conducted?
This trial has 20 study locations across California, Florida, Maryland, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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