NCT06979596

A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)

A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones. Researchers will compare MK-5684 to the standard treatments for each cancer type in this study. The goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	Opevesostat	Tablet for oral administration.
DRUG	Fludrocortisone/ Fludrocortisone acetate	Tablet for oral administration.
DRUG	Dexamethasone/Dexamethasone acetate	Tablet for oral administration.
DRUG	Rescue Medications	Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
DRUG	Fulvestrant	Administered via intramuscular injection.
DRUG	Exemestane	Tablet for oral administration.
DRUG	Megestrol acetate/Medroxyprogesterone acetate	Tablet for oral administration.
DRUG	Tamoxifen	Tablet for oral administration.
DRUG	Letrozole	Tablet for oral administration.

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-11-04
• Completion: 2027-11-04
• First posted: 2025-05-20
• Last updated: 2026-04-13

Locations

52 sites across 13 countries: United States, Argentina, Brazil, Canada, Chile, Malaysia, Peru, Singapore, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study