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)
Public ClinicalTrials.gov record NCT06353386. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06353386
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 220 participants
Conditions and interventions
Conditions
Interventions
- Opevesostat Drug
- Olaparib Drug
- Docetaxel Drug
- Cabazitaxel Drug
- Fludrocortisone acetate Drug
- Dexamethasone Drug
- Prednisone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 19, 2024
- Primary completion
- Jan 14, 2029
- Completion
- Jan 14, 2029
- Last update posted
- May 25, 2026
2024 – 2029
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSD Moores Cancer Center ( Site 0039) | La Jolla | California | 92037 | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 0044) | Los Angeles | California | 90404 | Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051) | Miami | Florida | 33136 | Recruiting |
| University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049) | Baltimore | Maryland | 21201 | Active, not recruiting |
| Rutgers Cancer Institute of New Jersey ( Site 0033) | New Brunswick | New Jersey | 08903-2681 | Active, not recruiting |
| University Hospitals Cleveland Medical Center ( Site 0043) | Cleveland | Ohio | 44106 | Recruiting |
| MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020) | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 70 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06353386, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 25, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06353386 live on ClinicalTrials.gov.