A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)
- Malignant Neoplasm
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 250
- Started
- 11 August 2025
- Main results due
- 4 November 2027
- Study sites
- 60
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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 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 Criteria: The main exclusion criteria include but are not limited to the following: * 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 study is about
In the sponsor’s own words, from the registry.
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.
Study sites(60)
Alaska Womens Cancer Care ( Site 0037)
Anchorage, Alaska, United States
Recruiting
Mount Sinai Cancer Center ( Site 0009)
Miami Beach, Florida, United States
Recruiting
TRIALS 365 ( Site 0022)
Shreveport, Louisiana, United States
Recruiting
Mary Lanning Healthcare ( Site 0019)
Hastings, Nebraska, United States
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)
Hackensack, New Jersey, United States
Recruiting
Rockefeller Outpatient Pavilion ( Site 0002)
New York, New York, United States
Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)
Columbus, Ohio, United States
Recruiting
Baylor College of Medicine Medical Center ( Site 0004)
Houston, Texas, United States
Recruiting
Harris Health System ( Site 0040)
Houston, Texas, United States
Recruiting
Mays Cancer Center ( Site 0039)
San Antonio, Texas, United States
Recruiting
Hospital Aleman ( Site 0301)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)
Buenos Aires, Buenos Aires F.D., Argentina
Recruiting
Instituto Alexander Fleming ( Site 0303)
Buenos Aires, Buenos Aires F.D., Argentina
Recruiting
Hospital Santa Rita de Cassia ( Site 3104)
Vitória, Espírito Santo, Brazil
Recruiting
Obras Sociais Irma Dulce ( Site 3112)
Salvador, Estado de Bahia, Brazil
Recruiting
Hospital Felicio Rocho ( Site 3105)
Belo Horizonte, Minas Gerais, Brazil
Recruiting
Hospital de Cancer de Pernambuco ( Site 3103)
Recife, Pernambuco, Brazil
Recruiting
Liga Norte Riograndense Contra o Cancer ( Site 3108)
Natal, Rio Grande do Norte, Brazil
Recruiting
Instituto Nacional de Câncer - INCA ( Site 3107)
Rio de Janeiro, Brazil
Recruiting
Sunnybrook Research Institute ( Site 0203)
Toronto, Ontario, Canada
Recruiting
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, Canada
Recruiting
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)
Montreal, Quebec, Canada
Recruiting
Jewish General Hospital ( Site 0201)
Montreal, Quebec, Canada
Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0205)
Sherbrooke, Quebec, Canada
Recruiting
FALP ( Site 3300)
Santiago, Region M. de Santiago, Chile
Recruiting
Pontificia Universidad Catolica de Chile ( Site 3307)
Santiago, Region M. de Santiago, Chile
Recruiting
Bradfordhill ( Site 3301)
Santiago, Region M. de Santiago, Chile
Recruiting
ONCOCENTRO APYS ( Site 3302)
Viña del Mar, Valparaiso, Chile
Recruiting
Sarawak General Hospital ( Site 0602)
Kuching, Sarawak, Malaysia
Recruiting
Pantai Hospital Kuala Lumpur ( Site 0603)
Kuala Lumpur, Malaysia
Recruiting
University Malaya Medical Centre ( Site 0601)
Kuala Lumpur, Malaysia
Recruiting
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 3405)
Concepción, Departamento de Junín, Peru
Recruiting
Clínica San Antonio ( Site 3404)
Trujillo, La Libertad, Peru
Recruiting
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)
Lima, Peru
Recruiting
Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)
Lima, Peru
Recruiting
National Cancer Centre Singapore ( Site 0800)
Singapore, Central Singapore, Singapore
Recruiting
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)
L'Hospitalet de Llobregat, Barcelona, Spain
Recruiting
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)
A Coruña, La Coruna, Spain
Recruiting
Clinica Universitaria Navarra - Madrid ( Site 2004)
Madrid, Madrid, Comunidad de, Spain
Recruiting
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)
Madrid, Madrid, Comunidad de, Spain
Recruiting
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)
Madrid, Spain
Recruiting
Taichung Veterans General Hospital ( Site 1004)
Taichung, Taiwan
Recruiting
National Cheng Kung University Hospital ( Site 1003)
Tainan, Taiwan
Recruiting
Mackay Memorial Hospital ( Site 1002)
Taipei, Taiwan
Recruiting
Faculty of Medicine Siriraj Hospital ( Site 1111)
Bangkok, Bangkok, Thailand
Recruiting
Chulalongkorn Hospital ( Site 1114)
Pathumwan, Bangkok, Thailand
Recruiting
Songklanagarind Hospital ( Site 1113)
Songkhla, Thailand
Recruiting
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2201)
Adana, Turkey (Türkiye)
Recruiting
Hacettepe Universitesi ( Site 2200)
Ankara, Turkey (Türkiye)
Recruiting
Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)
Edirne, Turkey (Türkiye)
Recruiting
Istanbul Universitesi Cerrahpasa ( Site 2203)
Istanbul, Turkey (Türkiye)
Recruiting
Koc University, School of Medicine ( Site 2202)
Istanbul, Turkey (Türkiye)
Recruiting
University Hospitals Sussex NHS Foundation Trust ( Site 2301)
East Sussex, Brighton And Hove, United Kingdom
Recruiting
The Royal Cornwall Hospital ( Site 2306)
Truro, Cornwall, United Kingdom
Recruiting
St Bartholomew's Hospital ( Site 2302)
London, London, City of, United Kingdom
Recruiting
University College Hospital London ( Site 2303)
London, London, City of, United Kingdom
Recruiting
Guy's & St Thomas' NHS Foundation Trust ( Site 2309)
London, London, City of, United Kingdom
Recruiting
Western General Hospital ( Site 2307)
Edinburgh, Midlothian, United Kingdom
Recruiting
Queen Elizabeth Hospital ( Site 2305)
Birmingham, United Kingdom
Recruiting
The Christie NHS Foundation Trust ( Site 2300)
Manchester, United Kingdom
Recruiting
Showing 60 of 60 sites. 60 of the 60 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06979596. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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