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NCT06136650 · ClinicalTrials.gov registry record · 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)

A Phase 3 study of Prostatic Neoplasms and Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 3
Development phase
1,314
Enrollment target
20
Study locations

NCT06136650: Recruiting Phase 3 study of Prostatic Neoplasms and Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by Merck Sharp & Dohme.

NCT06136650 is a Phase 3 study of Prostatic Neoplasms and Metastatic Castration-Resistant Prostate Cancer (mCRPC) that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,314 participants, above the 494-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (166% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06136650, a Phase 3 study of Prostatic Neoplasms and Metastatic Castration-Resistant Prostate Cancer (mCRPC), is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 3
Development phase
1,314 participants
Enrollment target
20
Study locations

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.

Primary Outcome

rPFS is defined as the time from randomization to the first documented disease progression per PCWG-modified RECIST 1.1 by BICR or death due to any cause, whichever occurs first.

Conditions Studied

Prostatic Neoplasms Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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
Merck Sharp & Dohme

558 total trials

What NCT06136650 shows while recruiting

NCT06136650 is an interventional study that assigns participants to a tested intervention. Its 1,314 participants enrollment target places it among the larger protocols in the corpus, above the 494-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (166% higher).

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.

NCT06136650 names 20 study sites across 7 states, led by California, Colorado, Florida.

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).

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).

Who is sponsoring clinical trial NCT06136650?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Prostatic Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06136650's enrollment target sits among peer trials

1,314 6th of 65 higher than 60 of 65 other Prostatic Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06136650

Source: ClinicalTrials.gov NCT06136650, the US trial registry maintained by the National Library of Medicine. NCT06136650 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.