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RECRUITING Phase 3

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)

NCT06136650 · View on ClinicalTrials.gov ↗

Study Summary

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 hypothesis is 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), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Interventions

  • DRUG Dexamethasone
  • DRUG Hydrocortisone
  • DRUG Abiraterone acetate
  • DRUG Opevesostat
  • DRUG Fludrocortisone acetate

Study Locations (20)

California

  • UCLA Hematology/Oncology - Santa Monica ( Site 0044) — Los Angeles
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) — Orange
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120) — Orange
  • Stanford Cancer Center ( Site 0036) — Palo Alto
  • Emad Ibrahim,MD,INC. ( Site 0012) — Redlands
  • Kaiser Permanente Riverside Medical Center ( Site 0099) — Riverside
  • University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114) — Sacramento
  • San Francisco VA Health Care System ( Site 0093) — San Francisco
  • Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101) — Vallejo

Colorado

  • University of Colorado Anschutz Medical Campus ( Site 0046) — Aurora
  • UCHealth Highlands Ranch Hospital ( Site 0111) — Highlands Ranch
  • Colorado Clinical Research ( Site 0067) — Lakewood
  • University of Colorado Health - Lone Tree Medical Center ( Site 0112) — Lone Tree

Florida

  • Florida Cancer Specialists - South ( Site 7003) — Fort Myers
  • Mount Sinai Cancer Center ( Site 0107) — Miami Beach
  • Memorial Hospital West-Memorial Cancer Institute ( Site 0109) — Pembroke Pines

Arizona

  • The University of Arizona Cancer Center - North Campus ( Site 0073) — Tucson

Connecticut

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) — New Haven

District of Columbia

  • MedStar Washington Hospital Center ( Site 0103) — Washington D.C.

Georgia

  • Northside Hospital-Northside Hospital Oncology Network ( Site 0100) — Atlanta

Trial Details

FieldValue
Enrollment Target 1,314 participants
Start Date 2023-12-18
Est. Completion 2030-12-02
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06136650

The ClinicalTrials.gov registry entry for NCT06136650 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 1,314 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 2 conditions, with Prostatic Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which Dexamethasone 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: NCT06136650 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Colorado, Florida. 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 NCT06136650 about?

NCT06136650 is a clinical study titled "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)". 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 ho...

What is the current status of trial NCT06136650?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,314 participants. The study started on 2023-12-18. Estimated completion is 2030-12-02.

What conditions does trial NCT06136650 study?

This clinical trial studies the following conditions: Prostatic Neoplasms, Metastatic Castration-resistant Prostate Cancer (mCRPC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06136650?

The interventions under investigation include: Dexamethasone (DRUG), Hydrocortisone (DRUG), Abiraterone acetate (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 NCT06136650?

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 NCT06136650 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial