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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 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-04-17

No results posted yet for this 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

  • Prostatic Neoplasms, Castration-Resistant

Interventions

DRUG

Opevesostat

Oral Tablet

DRUG

Olaparib

Oral Tablet

DRUG

Docetaxel

IV Infusion

DRUG

Cabazitaxel

IV Infusion

DRUG

Fludrocortisone acetate

Oral Tablet

DRUG

Dexamethasone

Oral Tablet

DRUG

Prednisone

Oral Tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2029-01-15
Completion
2029-01-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • Colombia
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Japan
  • New Zealand
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353386 on ClinicalTrials.gov