A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
Condition(s) studied
Investigational drug(s) / intervention(s)
Opevesostat: 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.
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
Primary outcome measure(s)
- Progression-Free Survival (PFS) - All Cohorts — Up 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.
Trial sites (60)
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Womens Cancer Care ( Site 0037) | Anchorage | Alaska | Recruiting |
| Mount Sinai Cancer Center ( Site 0009) | Miami Beach | Florida | Recruiting |
| TRIALS 365 ( Site 0022) | Shreveport | Louisiana | Recruiting |
| Mary Lanning Healthcare ( Site 0019) | Hastings | Nebraska | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021) | Hackensack | New Jersey | Recruiting |
| Rockefeller Outpatient Pavilion ( Site 0002) | New York | New York | Recruiting |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008) | Columbus | Ohio | Recruiting |
| Baylor College of Medicine Medical Center ( Site 0004) | Houston | Texas | Recruiting |
| Harris Health System ( Site 0040) | Houston | Texas | Recruiting |
| Mays Cancer Center ( Site 0039) | San Antonio | Texas | Recruiting |
| Hospital Aleman ( Site 0301) | Ciudad Autonoma de Buenos Aires | Buenos Aires | Recruiting |
| Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302) | Buenos Aires | Buenos Aires F.D. | Recruiting |
| Instituto Alexander Fleming ( Site 0303) | Buenos Aires | Buenos Aires F.D. | Recruiting |
| Hospital Santa Rita de Cassia ( Site 3104) | Vitória | Espírito Santo | Recruiting |
| Obras Sociais Irma Dulce ( Site 3112) | Salvador | Estado de Bahia | Recruiting |
| Hospital Felicio Rocho ( Site 3105) | Belo Horizonte | Minas Gerais | Recruiting |
| Hospital de Cancer de Pernambuco ( Site 3103) | Recife | Pernambuco | Recruiting |
| Liga Norte Riograndense Contra o Cancer ( Site 3108) | Natal | Rio Grande do Norte | Recruiting |
| Instituto Nacional de Câncer - INCA ( Site 3107) | Rio de Janeiro | Brazil | Recruiting |
| Sunnybrook Research Institute ( Site 0203) | Toronto | Ontario | Recruiting |
| Princess Margaret Cancer Centre ( Site 0202) | Toronto | Ontario | Recruiting |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200) | Montreal | Quebec | Recruiting |
| Jewish General Hospital ( Site 0201) | Montreal | Quebec | Recruiting |
| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0205) | Sherbrooke | Quebec | Recruiting |
| Fundación Arturo López Pérez ( Site 3300) | Santiago | Region M. de Santiago | Recruiting |
| Pontificia Universidad Catolica de Chile ( Site 3307) | Santiago | Region M. de Santiago | Recruiting |
| Bradfordhill ( Site 3301) | Santiago | Region M. de Santiago | Recruiting |
| ONCOCENTRO APYS ( Site 3302) | Viña del Mar | Valparaiso | Recruiting |
| Sarawak General Hospital ( Site 0602) | Kuching | Sarawak | 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 | Recruiting |
| Clínica San Antonio ( Site 3404) | Trujillo | La Libertad | 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 | Recruiting |
| Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000) | L'Hospitalet de Llobregat | Barcelona | Recruiting |
| CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003) | A Coruña | La Coruna | Recruiting |
| Clinica Universitaria Navarra - Madrid ( Site 2004) | Madrid | Madrid, Comunidad de | Recruiting |
| Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002) | Madrid | Madrid, Comunidad de | Recruiting |
+ 20 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Turkey
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06979596 on ClinicalTrials.gov ↗ ← All trials in Turkey