A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
NCT ID: NCT06979596
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
250 participants
INTERVENTIONAL
2025-08-11
2027-11-04
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment of Physician's Choice
Participants with endometrial cancer will receive the physician's choice of either 80 mg megestrol acetate/medroxyprogesterone acetate twice daily, or alternating between 80 mg megestrol acetate twice daily for three weeks and 20 mg tamoxifen twice daily for three weeks, or 2.5 mg letrozole once daily. Participants will receive treatment until one of the conditions for discontinuation of study intervention is met.
Megestrol acetate/Medroxyprogesterone acetate
Tablet for oral administration.
Tamoxifen
Tablet for oral administration.
Letrozole
Tablet for oral administration.
Fulvestrant or Exemestane
Participants with breast cancer receive endocrine therapy of the physician's choice: either 500 mg of fulvestrant on Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter (cycles are 28 days in length) or 25 mg of exemestane once daily (QD). Participants will receive treatment until one of the conditions for discontinuation of study intervention is met.
Fulvestrant
Administered via intramuscular injection.
Exemestane
Tablet for oral administration.
Observation (No Treatment)
Participants with ovarian cancer will be observed but will receive no treatment for the duration of the study.
No interventions assigned to this group
MK-5684 and Supportive Adrenal Therapy (SAT)
Participants with breast cancer, ovarian cancer, or endometrial cancer will receive 5 mg of MK-5684 orally twice daily. Participants will also receive fludrocortisone/fludrocortisone acetate starting at 0.1 mg orally, and dexamethasone/dexamethasone acetate starting at 1 mg orally; both will be adjusted individually during the study. Participants will receive treatment until one of the conditions for discontinuation of study intervention is met.
MK-5684
Tablet for oral administration.
Fludrocortisone/ Fludrocortisone acetate
Tablet for oral administration.
Dexamethasone/Dexamethasone acetate
Tablet for oral administration.
Rescue Medications
Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
Interventions
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MK-5684
Tablet for oral administration.
Fludrocortisone/ Fludrocortisone acetate
Tablet for oral administration.
Dexamethasone/Dexamethasone acetate
Tablet for oral administration.
Rescue Medications
Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
Fulvestrant
Administered via intramuscular injection.
Exemestane
Tablet for oral administration.
Megestrol acetate/Medroxyprogesterone acetate
Tablet for oral administration.
Tamoxifen
Tablet for oral administration.
Letrozole
Tablet for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Alaska Womens Cancer Care ( Site 0037)
Anchorage, Alaska, United States
Mount Sinai Cancer Center ( Site 0009)
Miami Beach, Florida, United States
TRIALS 365 ( Site 0022)
Shreveport, Louisiana, United States
Mary Lanning Healthcare ( Site 0019)
Hastings, Nebraska, United States
Hospital Aleman ( Site 0301)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)
Buenos Aires, Buenos Aires F.D., Argentina
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)
L'Hospitalet de Llobregat, Barcelona, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)
A Coruña, La Coruna, Spain
Clinica Universitaria Navarra - Madrid ( Site 2004)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)
Madrid, Madrid, Comunidad de, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)
Madrid, , Spain
Taichung Veterans General Hospital ( Site 1004)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 1003)
Tainan, , Taiwan
Mackay Memorial Hospital ( Site 1002)
Taipei, , Taiwan
University Hospitals Sussex NHS Foundation Trust ( Site 2301)
East Sussex, Brighton And Hove, United Kingdom
The Royal Cornwall Hospital ( Site 2306)
Truro, Cornwall, United Kingdom
The Christie NHS Foundation Trust ( Site 2300)
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
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Study Coordinator
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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2024-519563-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1315-5430
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-5684-015
Identifier Type: OTHER
Identifier Source: secondary_id
OMAHA-015
Identifier Type: OTHER
Identifier Source: secondary_id
5684-015
Identifier Type: -
Identifier Source: org_study_id