A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
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
| Condition(s) | Malignant Neoplasm |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 and received either, 1 line of an approved protocol-specified combination endocrine-based therapy, or 2 or more lines of protocol-specified endocrine-based therapy in the metastatic setting * Cohort B: * Has histologically confirmed high-grade epithelial (including hi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Locations | Anchorage, Alaska, United States; Miami Beach, Florida, United States; Shreveport, Louisiana, United States; Hastings, Nebraska, United States; Hackensack, New Jersey, United States; New York, New York, United States (+49 more sites) |
| Start date | 2025-08-11 |
| NCT ID | NCT06979596 |
| Official listing | https://clinicaltrials.gov/study/NCT06979596 |