A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)
Merck Sharp & Dohme LLC
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Cohort A: * Has a diagnosis of hormone receptor positive/Human Epidermal Growth Factor Receptor 2 negative (HR+/HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent. * Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting. * Cohort B: * Has histologically confirmed high-grade epi…
Interventions
- DrugOpevesostat
Tablet for oral administration.
- DrugFludrocortisone/ Fludrocortisone acetate
Tablet for oral administration.
- DrugDexamethasone/Dexamethasone acetate
Tablet for oral administration.
- DrugRescue Medications
Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
- DrugFulvestrant
Administered via intramuscular injection.
- DrugExemestane
Tablet for oral administration.
- Drug
Locations (52)
- Alaska Womens Cancer Care ( Site 0037)Anchorage, Alaska
- Mount Sinai Cancer Center ( Site 0009)Miami Beach, Florida
- TRIALS 365 ( Site 0022)Shreveport, Louisiana
- Mary Lanning Healthcare ( Site 0019)Hastings, Nebraska
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)Hackensack, New Jersey
- Baylor College of Medicine Medical Center ( Site 0004)Houston, Texas