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RECRUITING
NCT06979596
PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-08-11

Completion Date

2027-11-04

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

Opevesostat

Tablet for oral administration.

DRUG

Fludrocortisone/ Fludrocortisone acetate

Tablet for oral administration.

DRUG

Dexamethasone/Dexamethasone acetate

Tablet for oral administration.

DRUG

Rescue Medications

Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.

DRUG

Fulvestrant

Administered via intramuscular injection.

DRUG

Exemestane

Tablet for oral administration.

DRUG

Megestrol acetate/Medroxyprogesterone acetate

Tablet for oral administration.

DRUG

Tamoxifen

Tablet for oral administration.

DRUG

Letrozole

Tablet for oral administration.

Locations (49)

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

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

Hackensack, New Jersey, United States

Baylor College of Medicine Medical Center ( Site 0004)

Houston, Texas, United States

Mays Cancer Center ( Site 0039)

San Antonio, Texas, 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

Instituto Alexander Fleming ( Site 0303)

Buenos Aires, Buenos Aires F.D., Argentina

Obras Sociais Irma Dulce ( Site 3112)

Salvador, Estado de Bahia, Brazil

Hospital Felicio Rocho ( Site 3105)

Belo Horizonte, Minas Gerais, Brazil

Hospital de Cancer de Pernambuco ( Site 3103)

Recife, Pernambuco, Brazil

Liga Norte Riograndense Contra o Cancer ( Site 3108)

Natal, Rio Grande do Norte, Brazil

Instituto Nacional de Câncer - INCA ( Site 3107)

Rio de Janeiro, Brazil

Princess Margaret Cancer Centre ( Site 0202)

Toronto, Ontario, Canada

FALP ( Site 3300)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 3307)

Santiago, Region M. de Santiago, Chile

ONCOCENTRO APYS ( Site 3302)

Viña del Mar, Región de Valparaíso, Chile

Sarawak General Hospital ( Site 0602)

Kuching, Sarawak, Malaysia

Pantai Hospital Kuala Lumpur ( Site 0603)

Kuala Lumpur, Malaysia

University Malaya Medical Centre ( Site 0601)

Kuala Lumpur, Malaysia

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

Concepción, Departamento de Junín, Peru

Clínica San Antonio ( Site 3404)

Trujillo, La Libertad, Peru

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)

Lima, Peru

Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)

Lima, Peru

National Cancer Centre Singapore ( Site 0800)

Singapore, Central Singapore, Singapore

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

Chulalongkorn Hospital ( Site 1114)

Bangkok, Bangkok, Thailand

Faculty of Medicine Siriraj Hospital ( Site 1111)

Bangkok, Bangkok, Thailand

Songklanagarind Hospital ( Site 1113)

Songkhla, Thailand

Hacettepe Universitesi ( Site 2200)

Ankara, Turkey (Türkiye)

Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)

Edirne, Turkey (Türkiye)

Koc University, School of Medicine ( Site 2202)

Istanbul, Turkey (Türkiye)

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

St Bartholomew's Hospital ( Site 2302)

London, London, City of, United Kingdom

University College Hospital London ( Site 2303)

London, London, City of, United Kingdom

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

London, London, City of, United Kingdom

Western General Hospital ( Site 2307)

Edinburgh, Midlothian, United Kingdom

Queen Elizabeth Hospital ( Site 2305)

Birmingham, United Kingdom

The Christie NHS Foundation Trust ( Site 2300)

Manchester, United Kingdom