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New Hormone-Blocking drug shows promise in cancer trial

NCT ID NCT06979596

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 6 times

Summary

This study tests MK-5684, a drug that blocks the body from making steroid hormones, in people with breast, ovarian, or endometrial cancer. Researchers want to see if it helps patients live longer without their cancer growing compared to standard treatments. The trial is recruiting 250 participants and is currently in Phase 2.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-5684 (opevesostat), a drug that blocks steroid hormone production, given with supportive medications like fludrocortisone and dexamethasone.
What this could lead to
If successful, MK-5684 could offer a new treatment option that delays cancer growth in hormone-sensitive solid tumors.
What could go wrong
This is an early Phase 2 trial with only 250 participants, so results may not apply to all patients. Side effects from hormone suppression and added medications are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cancer endometrioid adenocarcinoma fallopian tube serous adenocarcinoma hormone receptor-positive breast cancer neoplasm ovarian adenocarcinoma ovarian carcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    59 sites in 13 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alaska Womens Cancer Care ( Site 0037)

    RECRUITING

    Anchorage, Alaska, 99508, United States

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

    RECRUITING

    Adana, 01240, Turkey (Türkiye)

  • Baylor College of Medicine Medical Center ( Site 0004)

    RECRUITING

    Houston, Texas, 77030, United States

  • Bradfordhill ( Site 3301)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

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

    RECRUITING

    A Coruña, La Coruna, 15006, Spain

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0205)

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

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

    RECRUITING

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

  • Chulalongkorn Hospital ( Site 1114)

    RECRUITING

    Bangkok, Bangkok, 10330, Thailand

  • Clinica Universitaria Navarra - Madrid ( Site 2004)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Clínica San Antonio ( Site 3404)

    RECRUITING

    Trujillo, La Libertad, 13008, Peru

  • FALP ( Site 3300)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Faculty of Medicine Siriraj Hospital ( Site 1111)

    RECRUITING

    Bangkok, Bangkok, 10700, Thailand

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

    RECRUITING

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

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

    RECRUITING

    Madrid, 28223, Spain

  • Hacettepe Universitesi ( Site 2200)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Harris Health System ( Site 0040)

    RECRUITING

    Houston, Texas, 77054, United States

  • Hospital Aleman ( Site 0301)

    RECRUITING

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina

  • Hospital Felicio Rocho ( Site 3105)

    RECRUITING

    Belo Horizonte, Minas Gerais, 30110-934, Brazil

  • Hospital Santa Rita de Cassia ( Site 3104)

    RECRUITING

    Vitória, Espírito Santo, 29043-260, Brazil

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

    RECRUITING

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hospital de Cancer de Pernambuco ( Site 3103)

    RECRUITING

    Recife, Pernambuco, 50040-000, Brazil

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

    RECRUITING

    Lima, 15036, Peru

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

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Instituto Alexander Fleming ( Site 0303)

    RECRUITING

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

  • Instituto Nacional de Câncer - INCA ( Site 3107)

    RECRUITING

    Rio de Janeiro, 20230-130, Brazil

  • Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)

    RECRUITING

    Lima, 15038, Peru

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

    RECRUITING

    Concepción, Departamento de Junín, 12125, Peru

  • Istanbul Universitesi Cerrahpasa ( Site 2203)

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Jewish General Hospital ( Site 0201)

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

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

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Koc University, School of Medicine ( Site 2202)

    RECRUITING

    Istanbul, 34450, Turkey (Türkiye)

  • Liga Norte Riograndense Contra o Cancer ( Site 3108)

    RECRUITING

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

  • Mackay Memorial Hospital ( Site 1002)

    RECRUITING

    Taipei, 10449, Taiwan

  • Mary Lanning Healthcare ( Site 0019)

    RECRUITING

    Hastings, Nebraska, 68901, United States

  • Mays Cancer Center ( Site 0039)

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Mount Sinai Cancer Center ( Site 0009)

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • National Cancer Centre Singapore ( Site 0800)

    RECRUITING

    Singapore, Central Singapore, 168583, Singapore

  • National Cheng Kung University Hospital ( Site 1003)

    RECRUITING

    Tainan, 704, Taiwan

  • ONCOCENTRO APYS ( Site 3302)

    RECRUITING

    Viña del Mar, Valparaiso, 2520598, Chile

  • Obras Sociais Irma Dulce ( Site 3112)

    RECRUITING

    Salvador, Estado de Bahia, 41680-430, Brazil

  • Pantai Hospital Kuala Lumpur ( Site 0603)

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Pontificia Universidad Catolica de Chile ( Site 3307)

    RECRUITING

    Santiago, Region M. de Santiago, 8330032, Chile

  • Princess Margaret Cancer Centre ( Site 0202)

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Elizabeth Hospital ( Site 2305)

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Rockefeller Outpatient Pavilion ( Site 0002)

    RECRUITING

    New York, New York, 10022, United States

  • Sarawak General Hospital ( Site 0602)

    RECRUITING

    Kuching, Sarawak, 93586, Malaysia

  • Songklanagarind Hospital ( Site 1113)

    RECRUITING

    Songkhla, 90110, Thailand

  • St Bartholomew's Hospital ( Site 2302)

    RECRUITING

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

  • TRIALS 365 ( Site 0022)

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Taichung Veterans General Hospital ( Site 1004)

    RECRUITING

    Taichung, 407, Taiwan

  • The Christie NHS Foundation Trust ( Site 2300)

    RECRUITING

    Manchester, M20 4BX, United Kingdom

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

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Royal Cornwall Hospital ( Site 2306)

    RECRUITING

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)

    RECRUITING

    Edirne, 22030, Turkey (Türkiye)

  • University College Hospital London ( Site 2303)

    RECRUITING

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

  • University Hospitals Sussex NHS Foundation Trust ( Site 2301)

    RECRUITING

    East Sussex, Brighton And Hove, BN2 1ES, United Kingdom

  • University Malaya Medical Centre ( Site 0601)

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Western General Hospital ( Site 2307)

    RECRUITING

    Edinburgh, Midlothian, EH4 2XU, United Kingdom

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