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RecruitingPhase 2NCT06979596

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

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Trial Parameters

ConditionMalignant Neoplasm
SponsorMerck Sharp & Dohme LLC
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment250
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-08-11
Completion2027-11-04
Interventions
OpevesostatFludrocortisone/ Fludrocortisone acetateDexamethasone/Dexamethasone acetate

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Brief 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 Criteria

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 epithelial (including high-grade serous or predominantly serous, high-grade endometrioid, malignant mixed Müllerian tumors \[carcinosarcoma\], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma. * Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line (3L) setting for ovarian cancer. * Cohort C: * Histologically confirmed diagnosis of primary advanced or re

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