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NCT06136624 · ClinicalTrials.gov registry record · Phase 3

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

A Phase 3 study of Prostate Cancer Metastatic, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 3
Development phase
1,310
Enrollment target
20
Study locations

NCT06136624 is a Phase 3 study of Prostate Cancer Metastatic that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,310 participants, above the 151-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (768% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT06136624, a Phase 3 study of Prostate Cancer Metastatic, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 3
Development phase
1,310 participants
Enrollment target
20
Study locations

Study Summary

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

Conditions Studied

Prostate Cancer Metastatic

Interventions

  • DRUG Enzalutamide
  • DRUG Hydrocortisone
  • DRUG Abiraterone acetate
  • DRUG Opevesostat
  • DRUG Fludrocortisone acetate

Study Locations (20)

Colorado

  • Anschutz Cancer Pavilion ( Site 0046) - Aurora
  • University of Colorado Health - 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

California

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) - Orange
  • Stanford Cancer Center ( Site 0036) - Palo Alto
  • Kaiser Permanente Riverside Medical Center ( Site 0099) - Riverside

Florida

  • Florida Cancer Specialists - South ( Site 7003) - Fort Myers
  • Bruce W. Carter Veterans Affairs Medical Center ( Site 0082) - Miami
  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051) - Miami

Illinois

  • University of Illinois at Chicago ( Site 0105) - Chicago
  • University of Chicago Medical Center ( Site 0045) - Chicago

Maryland

  • Baltimore Veterans Affairs Medical Center ( Site 0069) - Baltimore
  • Greenebaum Comprehensive Cancer Center ( Site 0049) - Baltimore

Connecticut

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

Iowa

  • University of Iowa ( Site 0047) - Iowa City

Kentucky

  • University of Kentucky Chandler Medical Center ( Site 0048) - Lexington

Trial Details

FieldValue
Enrollment Target 1,310 participants
Start Date 2023-12-31
Est. Completion 2028-08-02
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06136624

The ClinicalTrials.gov registry entry for NCT06136624 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,310 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 151-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (768% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer Metastatic appearing as the primary indexed condition, and to 5 interventions - of which Enzalutamide is the first listed.

NCT06136624 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Colorado, California, Florida.

Frequently Asked Questions

What is clinical trial NCT06136624 about?

NCT06136624 is a clinical study titled "Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)". This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-genera...

What is the current status of trial NCT06136624?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,310 participants. The study started on 2023-12-31. Estimated completion is 2028-08-02.

What conditions does trial NCT06136624 study?

This clinical trial studies the following conditions: Prostate Cancer Metastatic.

What interventions are being tested in trial NCT06136624?

The interventions under investigation include: Enzalutamide (DRUG), Hydrocortisone (DRUG), Abiraterone acetate (DRUG), Opevesostat (DRUG), Fludrocortisone acetate (DRUG).

Who is sponsoring clinical trial NCT06136624?

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

Where is trial NCT06136624 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.