Clinical trial Recruiting at 60 sites Phase 2 Interventional Ages 18 and up

MK-5684 for breast, ovarian, and endometrial cancer

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

Run by Merck Sharp & Dohme LLC · NCT06979596 · Data updated 2026-11-12

This trial will test whether MK-5684 helps people with certain breast, ovarian, or endometrial cancers live longer without the disease growing or spreading.

More Malignant Neoplasm trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorMerck Sharp & Dohme LLC
Industry-sponsored
Drugs / interventionschemotherapy
Locations60 sites (Anchorage, Alaska and 59 other locations)
StatusRecruiting
StartedAugust 11, 2025
Main results expectedNovember 4, 2027
Study endsNovember 4, 2027
Registry record updatedOctober 6, 2026
Trial IDNCT06979596 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal participants are adults with HR+/HER2‑ metastatic or unresectable breast cancer after prior endocrine therapy, or adults with high‑grade epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who meet the trial's other medical criteria.

Probably not a fit

Patients with tumors not driven by steroid hormones, early-stage disease that can be cured by surgery, or those unable to tolerate steroid-suppression medications are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MK-5684 is an experimental drug designed to block the body's production of steroid hormones that can fuel some cancers. In this Phase 2 study, people with hormone receptor–positive metastatic or unresectable breast cancer and people with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer are assigned to receive MK-5684 or a standard treatment for their cancer type and monitored for tumor growth and survival. The primary goal is to determine whether MK-5684 prolongs progression-free survival compared with standard therapy. Supportive medications such as fludrocortisone, dexamethasone, and fulvestrant may be given per protocol as needed.

Why it matters

Potential benefit: If successful, MK-5684 could extend the time patients live without their cancer getting worse compared with current standard treatments.

How similar studies have gone: Other drugs that block steroid hormone synthesis have shown benefit in some hormone-driven cancers, but MK-5684 is a newer agent with limited prior clinical data.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • 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
Show 44 more locations
  • 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
  • Fundación Arturo López Pérez ( 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

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.