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

Last updated: May 11, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

Exemestane

Fludrocortisone/ Fludrocortisone acetate

Megestrol acetate/Medroxyprogesterone acetate

Clinical Study ID

NCT06979596
5684-015
OMAHA-015
MK-5684-015
U1111-1315-5430
2024-519563-18
2024-519563-18-00
  • Ages > 18
  • All Genders

Study 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

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 FactorReceptor 2 negative (HR+/HER2-) invasive breast carcinoma that is eitherlocally advanced disease not amenable to resection with curative intent (hereincalled unresectable) or metastatic disease not treatable with curative intent.

  • Has experienced disease progression on or after at least 1 priorendocrine-based therapy in the metastatic setting and received either, 1 lineof an approved protocol-specified combination endocrine-based therapy, or 2 ormore lines of protocol-specified endocrine-based therapy in the metastaticsetting

  • Cohort B:

  • Has histologically confirmed high-grade epithelial (including high-grade serousor predominantly serous, high-grade endometrioid, malignant mixed Mülleriantumors [carcinosarcoma], or clear cell) ovarian, fallopian tube, or primaryperitoneal carcinoma.

  • Has received between 4 to 8 cycles of platinum-based doublet chemotherapy inthird-line (3L) setting for ovarian cancer.

  • Cohort C:

  • Histologically confirmed diagnosis of primary advanced or recurrent low-gradeendometrioid 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 ineither the advanced/metastatic OR adjuvant/neoadjuvant setting.

  • All Cohorts :

  • Participants who have AEs due to previous anticancer therapies must haverecovered to ≤Grade 1 or baseline.

  • Human immunodeficiency virus (HIV)-infected participants must have wellcontrolled HIV on antiretroviral therapy.

  • Participants who are Hepatitis B surface antigen positive are eligible if theyhave received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeksand have undetectable HBV viral load.

  • Participants with a history of Hepatitis C virus (HCV) infection are eligibleif HCV viral load is undetectable.

Exclusion

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 rapidlyevolving into life-threatening complications, such as lymphangitic lungmetastases, radiographic evidence of intratumoral cavitation orinvasion/infiltration of a major blood vessel, bone marrow replacement,carcinomatous meningitis, significant symptomatic liver metastases, symptomaticpericardial effusion, symptomatic peritoneal carcinomatosis, or the need toachieve rapid symptom control.

  • Cohort B:

  • Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors),borderline tumors (low malignant potential), mucinous, seromucinous that ispredominantly mucinous, malignant Brenner's tumor, low-grade serous, low-gradeendometrioid, and undifferentiated carcinoma.

  • Has platinum-resistant ovarian cancer (defined as disease that has progressedper radiographic imaging within 180 days after the last dose of first-line [1L]platinum-based therapy) or platinum-refractory ovarian cancer (defined asdisease 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 forovarian cancer.

  • Cohort C:

  • Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinomaand nonendometrioid histologies of any type (including serous, clear cell,mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterinemesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, orother 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 orallyadministered medication, or conditions which would impair absorption of oralmedications.

  • Has any prior history or current condition of adrenal insufficiency.

  • HIV-infected participants with a history of Kaposi's sarcoma and/orMulticentric Castleman's Disease.

  • Has received a live or live-attenuated vaccine within 30 days before the firstdose of study intervention. Administration of killed vaccines is allowed.

  • Has a known additional malignancy that is progressing or has required activetreatment within the past 3 years.

  • Has known active central nervous system metastases and/or carcinomatousmeningitis.

  • Has a history of stem cell/solid organ transplant.

  • Has not adequately recovered from major surgery or has ongoing surgicalcomplications.

Study Design

Total Participants: 250
Treatment Group(s): 10
Primary Treatment: Exemestane
Phase: 2
Study Start date:
August 11, 2025
Estimated Completion Date:
November 04, 2027

Connect with a study center

  • Hospital Aleman ( Site 0301)

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT
    Argentina

    Active - Recruiting

  • Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)

    Buenos Aires, Buenos Aires F.D. C1118AAT
    Argentina

    Active - Recruiting

  • Instituto Alexander Fleming ( Site 0303)

    Buenos Aires, Buenos Aires F.D. C1426ANZ
    Argentina

    Active - Recruiting

  • Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1118AAT
    Argentina

    Active - Recruiting

  • Instituto Alexander Fleming ( Site 0303)

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1426ANZ
    Argentina

    Site Not Available

  • Hospital Santa Rita de Cassia ( Site 3104)

    Vitória, Espírito Santo 29043-260
    Brazil

    Active - Recruiting

  • Obras Sociais Irma Dulce ( Site 3112)

    Salvador, Estado de Bahia 41680-430
    Brazil

    Active - Recruiting

  • Obras Sociais Irma Dulce ( Site 3112)

    Salvador 3450554, Estado de Bahia 3471168 41680-430
    Brazil

    Site Not Available

  • Hospital Felicio Rocho ( Site 3105)

    Belo Horizonte, Minas Gerais 30110-934
    Brazil

    Active - Recruiting

  • Hospital Felicio Rocho ( Site 3105)

    Belo Horizonte 3470127, Minas Gerais 3457153 30110-934
    Brazil

    Site Not Available

  • Hospital de Cancer de Pernambuco ( Site 3103)

    Recife, Pernambuco 50040-000
    Brazil

    Active - Recruiting

  • Hospital de Cancer de Pernambuco ( Site 3103)

    Recife 3390760, Pernambuco 3392268 50040-000
    Brazil

    Site Not Available

  • Liga Norte Riograndense Contra o Cancer ( Site 3108)

    Natal, Rio Grande do Norte 59062-000
    Brazil

    Active - Recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 3108)

    Natal 3394023, Rio Grande do Norte 3390290 59062-000
    Brazil

    Site Not Available

  • Instituto Nacional de Câncer - INCA ( Site 3107)

    Rio de Janeiro, 20230-130
    Brazil

    Active - Recruiting

  • Princess Margaret Cancer Centre ( Site 0202)

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre ( Site 0202)

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • Bradfordhill ( Site 3301)

    Santiago, Region M. de Santiago 8420383
    Chile

    Active - Recruiting

  • FALP ( Site 3300)

    Santiago, Region M. de Santiago 7500921
    Chile

    Active - Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 3307)

    Santiago, Region M. de Santiago 8330032
    Chile

    Active - Recruiting

  • FALP ( Site 3300)

    Santiago 3871336, Region M. de Santiago 7500921
    Chile

    Site Not Available

  • Pontificia Universidad Catolica de Chile ( Site 3307)

    Santiago 3871336, Region M. de Santiago 8330032
    Chile

    Active - Recruiting

  • ONCOCENTRO APYS ( Site 3302)

    Viña del Mar 3868121, Región de Valparaíso 3868621 2520598
    Chile

    Site Not Available

  • ONCOCENTRO APYS ( Site 3302)

    Viña del Mar, Valparaiso 2520598
    Chile

    Active - Recruiting

  • Sarawak General Hospital ( Site 0602)

    Kuching, Sarawak 93586
    Malaysia

    Active - Recruiting

  • Sarawak General Hospital ( Site 0602)

    Kuching 1735634, Sarawak 1733038 93586
    Malaysia

    Site Not Available

  • Pantai Hospital Kuala Lumpur ( Site 0603)

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre ( Site 0601)

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • Pantai Hospital Kuala Lumpur ( Site 0603)

    Kuala Lumpur 1735161, 59100
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre ( Site 0601)

    Kuala Lumpur 1735161, 59100
    Malaysia

    Site Not Available

  • Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 3405)

    Concepción, Departamento de Junín 12125
    Peru

    Active - Recruiting

  • Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 3405)

    Concepción 3942548, Departamento de Junín 3937485 12125
    Peru

    Site Not Available

  • Clínica San Antonio ( Site 3404)

    Trujillo, La Libertad 13008
    Peru

    Active - Recruiting

  • Clínica San Antonio ( Site 3404)

    Trujillo 3691175, La Libertad 3695781 13008
    Peru

    Site Not Available

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)

    Lima, 15036
    Peru

    Active - Recruiting

  • Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)

    Lima, 15038
    Peru

    Active - Recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)

    Lima 3936456, 15036
    Peru

    Site Not Available

  • Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)

    Lima 3936456, 15038
    Peru

    Active - Recruiting

  • National Cancer Centre Singapore ( Site 0800)

    Singapore, Central Singapore 168583
    Singapore

    Active - Recruiting

  • National Cancer Centre Singapore ( Site 0800)

    Singapore 1880252, Central Singapore 168583
    Singapore

    Site Not Available

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)

    L'Hospitalet de Llobregat, Barcelona 08908
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)

    L'Hospitalet de Llobregat 3120619, Barcelona 08908
    Spain

    Site Not Available

  • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)

    A Coruña, La Coruna 15006
    Spain

    Active - Recruiting

  • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)

    A Coruña 3119841, La Coruna 15006
    Spain

    Site Not Available

  • Clinica Universitaria Navarra - Madrid ( Site 2004)

    Madrid, Madrid, Comunidad de 28027
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)

    Madrid, Madrid, Comunidad de 28034
    Spain

    Active - Recruiting

  • Clinica Universitaria Navarra - Madrid ( Site 2004)

    Madrid 3117735, Madrid, Comunidad de 28027
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)

    Madrid 3117735, Madrid, Comunidad de 28034
    Spain

    Site Not Available

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)

    Madrid, 28223
    Spain

    Active - Recruiting

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)

    Madrid 3117735, 28223
    Spain

    Active - Recruiting

  • Taichung Veterans General Hospital ( Site 1004)

    Taichung, 407
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital ( Site 1004)

    Taichung 1668399, 407
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 1003)

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital ( Site 1003)

    Tainan 1668355, 704
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 1003)

    Tainan City 1668355, 704
    Taiwan

    Site Not Available

  • Mackay Memorial Hospital ( Site 1002)

    Taipei, 10449
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital ( Site 1002)

    Taipei 1668341, 10449
    Taiwan

    Site Not Available

  • Chulalongkorn Hospital ( Site 1114)

    Bangkok, Bangkok 10330
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 1111)

    Bangkok, Bangkok 10700
    Thailand

    Active - Recruiting

  • Chulalongkorn Hospital ( Site 1114)

    Bangkok 1609350, Bangkok 1609348 10330
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 1111)

    Bangkok 1609350, Bangkok 1609348 10700
    Thailand

    Site Not Available

  • Songklanagarind Hospital ( Site 1113)

    Songkhla, 90110
    Thailand

    Active - Recruiting

  • Songklanagarind Hospital ( Site 1113)

    Songkhla 1606147, 90110
    Thailand

    Site Not Available

  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2201)

    Adana, 01240
    Turkey (Türkiye)

    Active - Recruiting

  • Hacettepe Universitesi ( Site 2200)

    Ankara, 06230
    Turkey (Türkiye)

    Active - Recruiting

  • Hacettepe Universitesi ( Site 2200)

    Ankara 323786, 06230
    Turkey (Türkiye)

    Site Not Available

  • Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)

    Edirne, 22030
    Turkey (Türkiye)

    Active - Recruiting

  • Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)

    Edirne 747712, 22030
    Turkey (Türkiye)

    Site Not Available

  • Istanbul Universitesi Cerrahpasa ( Site 2203)

    Istanbul, 34098
    Turkey (Türkiye)

    Active - Recruiting

  • Koc University, School of Medicine ( Site 2202)

    Istanbul, 34450
    Turkey (Türkiye)

    Active - Recruiting

  • University Hospitals Sussex NHS Foundation Trust ( Site 2301)

    East Sussex, Brighton And Hove BN2 1ES
    United Kingdom

    Active - Recruiting

  • The Royal Cornwall Hospital ( Site 2306)

    Truro, Cornwall TR1 3LJ
    United Kingdom

    Active - Recruiting

  • The Royal Cornwall Hospital ( Site 2306)

    Truro 2635412, Cornwall TR1 3LJ
    United Kingdom

    Site Not Available

  • Guy's & St Thomas' NHS Foundation Trust ( Site 2309)

    London, London, City of SE1 9RT
    United Kingdom

    Active - Recruiting

  • St Bartholomew's Hospital ( Site 2302)

    London, London, City of EC1A 7BE
    United Kingdom

    Active - Recruiting

  • University College Hospital London ( Site 2303)

    London, London, City of NW1 2PG
    United Kingdom

    Active - Recruiting

  • Guy's & St Thomas' NHS Foundation Trust ( Site 2309)

    London 2643743, London, City of SE1 9RT
    United Kingdom

    Site Not Available

  • St Bartholomew's Hospital ( Site 2302)

    London 2643743, London, City of EC1A 7BE
    United Kingdom

    Active - Recruiting

  • University College Hospital London ( Site 2303)

    London 2643743, London, City of NW1 2PG
    United Kingdom

    Active - Recruiting

  • Western General Hospital ( Site 2307)

    Edinburgh, Midlothian EH4 2XU
    United Kingdom

    Active - Recruiting

  • Western General Hospital ( Site 2307)

    Edinburgh 2650225, Midlothian EH4 2XU
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital ( Site 2305)

    Birmingham, B15 2GW
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital ( Site 2305)

    Birmingham 2655603, B15 2GW
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust ( Site 2300)

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust ( Site 2300)

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • Alaska Womens Cancer Care ( Site 0037)

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Alaska Womens Cancer Care ( Site 0037)

    Anchorage 5879400, Alaska 5879092 99508
    United States

    Site Not Available

  • Mount Sinai Cancer Center ( Site 0009)

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Mount Sinai Cancer Center ( Site 0009)

    Miami Beach 4164143, Florida 4155751 33140
    United States

    Site Not Available

  • TRIALS 365 ( Site 0022)

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • TRIALS 365 ( Site 0022)

    Shreveport 4341513, Louisiana 4331987 71103
    United States

    Site Not Available

  • Mary Lanning Healthcare ( Site 0019)

    Hastings, Nebraska 68901
    United States

    Active - Recruiting

  • Mary Lanning Healthcare ( Site 0019)

    Hastings 5069802, Nebraska 5073708 68901
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center ( Site 0002)

    New York, New York 10065
    United States

    Active - Recruiting

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Baylor College of Medicine Medical Center ( Site 0004)

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Mays Cancer Center ( Site 0039)

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Baylor College of Medicine Medical Center ( Site 0004)

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Mays Cancer Center ( Site 0039)

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

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