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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06979596

Registry updated: 2026-10-06
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Description

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.

Interventions

  • Opevesostat (Drug)
    Tablet for oral administration.
  • Fludrocortisone/ Fludrocortisone acetate (Drug)
    Tablet for oral administration.
  • Dexamethasone/Dexamethasone acetate (Drug)
    Tablet for oral administration.
  • Rescue Medications (Drug)
    Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
  • Fulvestrant (Drug)
    Administered via intramuscular injection.
  • Exemestane (Drug)
    Tablet for oral administration.
  • Megestrol acetate/Medroxyprogesterone acetate (Drug)
    Tablet for oral administration.
  • Tamoxifen (Drug)
    Tablet for oral administration.
  • Letrozole (Drug)
    Tablet for oral administration.

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.

Conditions

Malignant Neoplasm

Locations

  • 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
  • Rockefeller Outpatient Pavilion ( Site 0002) — New York, New York, United States
  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008) — Columbus, Ohio, United States
  • Baylor College of Medicine Medical Center ( Site 0004) — Houston, Texas, United States
  • Harris Health System ( Site 0040) — 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
  • Hospital Santa Rita de Cassia ( Site 3104) — Vitória, Espírito Santo, Brazil
  • 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
  • Sunnybrook Research Institute ( Site 0203) — Toronto, Ontario, Canada
  • Princess Margaret Cancer Centre ( Site 0202) — Toronto, Ontario, Canada
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200) — Montreal, Quebec, Canada
  • Jewish General Hospital ( Site 0201) — Montreal, Quebec, Canada
  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0205) — Sherbrooke, Quebec, Canada
  • Fundación Arturo López Pérez ( Site 3300) — Santiago, Region M. de Santiago, Chile
  • Pontificia Universidad Catolica de Chile ( Site 3307) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill ( Site 3301) — Santiago, Region M. de Santiago, Chile
  • ONCOCENTRO APYS ( Site 3302) — Viña del Mar, Valparaiso, 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
  • Faculty of Medicine Siriraj Hospital ( Site 1111) — Bangkok, Bangkok, Thailand
  • Chulalongkorn Hospital ( Site 1114) — Pathumwan, Bangkok, Thailand
  • Songklanagarind Hospital ( Site 1113) — Songkhla, Thailand
  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2201) — Adana, Turkey (Türkiye)
  • Hacettepe Universitesi ( Site 2200) — Ankara, Turkey (Türkiye)
  • Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204) — Edirne, Turkey (Türkiye)
  • Istanbul Universitesi Cerrahpasa ( Site 2203) — Istanbul, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record