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

NCT06979596 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2027-11-04
Completion
2027-11-04
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Malaysia
  • Peru
  • Singapore
  • Spain
  • Taiwan
  • Thailand
  • 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 NCT06979596 on ClinicalTrials.gov