NCT06353386

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)

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-05-20
• Primary completion: 2029-01-15
• Completion: 2029-01-15
• First posted: 2024-04-09
• Last updated: 2026-04-17

Locations

77 sites across 20 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

Regulatory

• FDA-regulated drug study