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NCT06979596PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

8/11/2025

Completion Date

11/4/2027

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Opevesostat

DRUG

Fludrocortisone/ Fludrocortisone acetate

DRUG

Dexamethasone/Dexamethasone acetate

DRUG

Rescue Medications

DRUG

Fulvestrant

DRUG

Exemestane

DRUG

Megestrol acetate/Medroxyprogesterone acetate

DRUG

Tamoxifen

DRUG

Letrozole

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Conditions

Malignant Neoplasm

Locations

Alaska Womens Cancer Care ( Site 0037)

Anchorage, Alaska 99508

United States

Mount Sinai Cancer Center ( Site 0009)

Miami Beach, Florida 33140

United States

TRIALS 365 ( Site 0022)

Shreveport, Louisiana 71103

United States

Mary Lanning Healthcare ( Site 0019)

Hastings, Nebraska 68901

United States

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

Hackensack, New Jersey 07601

United States

Rockefeller Outpatient Pavilion ( Site 0002)

New York, New York 10022

United States

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

Columbus, Ohio 43210

United States

Baylor College of Medicine Medical Center ( Site 0004)

Houston, Texas 77030

United States

Harris Health System ( Site 0040)

Houston, Texas 77054

United States

Mays Cancer Center ( Site 0039)

San Antonio, Texas 78229

United States

Hospital Aleman ( Site 0301)

Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT

Argentina

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

Buenos Aires, Buenos Aires F.D. C1118AAT

Argentina

Instituto Alexander Fleming ( Site 0303)

Buenos Aires, Buenos Aires F.D. C1426ANZ

Argentina

Hospital Santa Rita de Cassia ( Site 3104)

Vitória, Espírito Santo 29043-260

Brazil

Obras Sociais Irma Dulce ( Site 3112)

Salvador, Estado de Bahia 41680-430

Brazil

Hospital Felicio Rocho ( Site 3105)

Belo Horizonte, Minas Gerais 30110-934

Brazil

Hospital de Cancer de Pernambuco ( Site 3103)

Recife, Pernambuco 50040-000

Brazil

Liga Norte Riograndense Contra o Cancer ( Site 3108)

Natal, Rio Grande do Norte 59062-000

Brazil

Instituto Nacional de Câncer - INCA ( Site 3107)

Rio de Janeiro, 20230-130

Brazil

Princess Margaret Cancer Centre ( Site 0202)

Toronto, Ontario M5G 2M9

Canada

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

Montreal, Quebec H2X 0C1

Canada

Jewish General Hospital ( Site 0201)

Montreal, Quebec H3T 1E2

Canada

FALP ( Site 3300)

Santiago, Region M. de Santiago 7500921

Chile

Pontificia Universidad Catolica de Chile ( Site 3307)

Santiago, Region M. de Santiago 8330032

Chile

Bradfordhill ( Site 3301)

Santiago, Region M. de Santiago 8420383

Chile

ONCOCENTRO APYS ( Site 3302)

Viña del Mar, Valparaiso 2520598

Chile

Sarawak General Hospital ( Site 0602)

Kuching, Sarawak 93586

Malaysia

Pantai Hospital Kuala Lumpur ( Site 0603)

Kuala Lumpur, 59100

Malaysia

University Malaya Medical Centre ( Site 0601)

Kuala Lumpur, 59100

Malaysia

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

Concepción, Departamento de Junín 12125

Peru

Clínica San Antonio ( Site 3404)

Trujillo, La Libertad 13008

Peru

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)

Lima, 15036

Peru

Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)

Lima, 15038

Peru

National Cancer Centre Singapore ( Site 0800)

Singapore, Central Singapore 168583

Singapore

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

L'Hospitalet de Llobregat, Barcelona 08908

Spain

CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)

A Coruña, La Coruna 15006

Spain

Clinica Universitaria Navarra - Madrid ( Site 2004)

Madrid, Madrid, Comunidad de 28027

Spain

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

Madrid, Madrid, Comunidad de 28034

Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)

Madrid, 28223

Spain

Taichung Veterans General Hospital ( Site 1004)

Taichung, 407

Taiwan

National Cheng Kung University Hospital ( Site 1003)

Tainan, 704

Taiwan

Mackay Memorial Hospital ( Site 1002)

Taipei, 10449

Taiwan

Chulalongkorn Hospital ( Site 1114)

Bangkok, Bangkok 10330

Thailand

Faculty of Medicine Siriraj Hospital ( Site 1111)

Bangkok, Bangkok 10700

Thailand

Songklanagarind Hospital ( Site 1113)

Songkhla, 90110

Thailand

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

Adana, 01240

Turkey (Türkiye)

Hacettepe Universitesi ( Site 2200)

Ankara, 06230

Turkey (Türkiye)

Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)

Edirne, 22030

Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa ( Site 2203)

Istanbul, 34098

Turkey (Türkiye)

Koc University, School of Medicine ( Site 2202)

Istanbul, 34450

Turkey (Türkiye)

University Hospitals Sussex NHS Foundation Trust ( Site 2301)

East Sussex, Brighton And Hove BN2 1ES

United Kingdom

The Royal Cornwall Hospital ( Site 2306)

Truro, Cornwall TR1 3LJ

United Kingdom

St Bartholomew's Hospital ( Site 2302)

London, London, City of EC1A 7BE

United Kingdom

University College Hospital London ( Site 2303)

London, London, City of NW1 2PG

United Kingdom

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

London, London, City of SE1 9RT

United Kingdom

Western General Hospital ( Site 2307)

Edinburgh, Midlothian EH4 2XU

United Kingdom

Queen Elizabeth Hospital ( Site 2305)

Birmingham, B15 2GW

United Kingdom

The Christie NHS Foundation Trust ( Site 2300)

Manchester, M20 4BX

United Kingdom