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A Study of MK-5684 for Certain Solid Tumors

This study is investigating MK-5684, a medication designed to treat cancer by blocking the body from making steroid hormones. Researchers want to see if MK-5684 can treat breast, ovarian, and endometrial cancers. You might be able to join if you are 18 or older and have certain types of breast cancer, specifically hormone receptor positive/HER2 negative (HR+/HER2-) invasive breast carcinoma that is locally advanced or has spread. The study will compare MK-5684 to standard treatments like Fulvestrant, Fludrocortisone, and Dexamethasone. The main goal is to see if people taking MK-5684 live longer without their cancer growing or spreading. The study plans to enroll about 250 people, but its current status is unclear.

Study design
This interventional study plans to enroll about 250 participants. It will compare MK-5684 to standard treatments for different cancer types.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long you live without the cancer growing or spreading for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06979596

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~250 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:OpevesostatFludrocortisone/ Fludrocortisone acetateDexamethasone/Dexamethasone acetateRescue MedicationsFulvestrantExemestane

At a glance

Recruiting sites
59 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) - All Cohorts
Measured over Up to approximately 2 years

Conditions

Malignant Neoplasm

Explore related trials

Breast CarcinomaEndometrial CarcinomaFallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal CarcinomaHormone Receptor

Where it's being run

59 sites across 39 states
Turkey (Türkiye)5
Texas3
Quebec3
Region M. de Santiago3
Taiwan3
London, City of3
Buenos Aires F.D.2
Malaysia2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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 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 recurrent low-grade endometrioid carcinoma (eg, Federation of Gynecology and Obstetrics \[FIGO\] Grade 1/2, or well/moderately differentiated).
Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced/metastatic OR adjuvant/neoadjuvant setting.
All Cohorts :
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
Participants who are Hepatitis B surface antigen positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.

Exclusion

Cohort A:
Breast cancer amenable to treatment with curative intent.
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion/infiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.
Cohort B:
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.
Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line \[1L\] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).
Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.
Cohort C:
Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.
Is a candidate for curative-intent surgery or curative-intent radiotherapy.
All Cohorts:
Has confirmed or suspected adrenal metastases.
Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.
Has any prior history or current condition of adrenal insufficiency.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has a history of stem cell/solid organ transplant.
Has not adequately recovered from major surgery or has ongoing surgical complications.

What this trial measures

  • Progression-Free Survival (PFS) - All CohortsUp to approximately 2 years

    For all cohorts, PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.