What this study is
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.
What's being tested
- Opevesostat
Intervention · DRUG
- Fludrocortisone/ Fludrocortisone acetate
Intervention · DRUG
- Dexamethasone/Dexamethasone acetate
Intervention · DRUG
- Rescue Medications
Intervention · DRUG
Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
- Fulvestrant
Intervention · DRUG
Administered via intramuscular injection.
- Exemestane
Intervention · DRUG
- Megestrol acetate/Medroxyprogesterone acetate
Intervention · DRUG
- Tamoxifen
Intervention · DRUG
- Letrozole
Intervention · DRUG
All of Opevesostat, Fludrocortisone/ Fludrocortisone acetate, Dexamethasone/Dexamethasone acetate, Exemestane, Megestrol acetate/Medroxyprogesterone acetate, Tamoxifen, Letrozole
Tablet for oral administration.
Study details
- Official title
- A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Malignant Neoplasm
- Enrolling
- 250 people
- Starts
- 2025-08-11
- Est. completion
- 2027-11-04
- Design
- Single-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedCohort A
You may qualify if
- 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.
- 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
You can't join if
- 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.
- 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.
Cohort B
You may qualify if
- 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.
- 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.
You can't join if
- 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.
- 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.
Cohort C
You may qualify if
- 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.
- 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.
You can't join if
- 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.
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (60)
60 openAlaska Womens Cancer Care ( Site 0037)
Anchorage, Alaska, United States
- Study Coordinator · Contact907-562-2211
RecruitingMount Sinai Cancer Center ( Site 0009)
Miami Beach, Florida, United States
- Study Coordinator · Contact305-674-2625
Recruiting- Recruiting
Mary Lanning Healthcare ( Site 0019)
Hastings, Nebraska, United States
- Study Coordinator · Contact402-463-4521
RecruitingJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)
Hackensack, New Jersey, United States
- Study Coordinator · Contact551-996-5855
RecruitingRockefeller Outpatient Pavilion ( Site 0002)
New York, New York, United States
- Study Coordinator · Contact212-639-2000
RecruitingThe James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)
Columbus, Ohio, United States
- Study Coordinator · Contact(614) 293-8000
RecruitingBaylor College of Medicine Medical Center ( Site 0004)
Houston, Texas, United States
- Study Coordinator · Contact713-798-2000
RecruitingHarris Health System ( Site 0040)
Houston, Texas, United States
- Study Coordinator · Contact713-798-1694
RecruitingMays Cancer Center ( Site 0039)
San Antonio, Texas, United States
- Study Coordinator · Contact210-450-1000
Recruiting
50 sites outside the US
Hospital Aleman ( Site 0301)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Study Coordinator · Contact+5491148277000
RecruitingCentro Medico Dr. Doreski - Fundación Respirar ( Site 0302)
Buenos Aires, Buenos Aires F.D., Argentina
- Study Coordinator · Contact+541147815331
RecruitingInstituto Alexander Fleming ( Site 0303)
Buenos Aires, Buenos Aires F.D., Argentina
- Study Coordinator · Contact+541132218900
RecruitingHospital Santa Rita de Cassia ( Site 3104)
Vitória, Espírito Santo, Brazil
- Study Coordinator · Contact+55 027 99846-9004
RecruitingObras Sociais Irma Dulce ( Site 3112)
Salvador, Estado de Bahia, Brazil
- Study Coordinator · Contact+557134836649
RecruitingHospital Felicio Rocho ( Site 3105)
Belo Horizonte, Minas Gerais, Brazil
- Study Coordinator · Contact+5531986622882
RecruitingHospital de Cancer de Pernambuco ( Site 3103)
Recife, Pernambuco, Brazil
- Study Coordinator · Contact+558132178084
RecruitingLiga Norte Riograndense Contra o Cancer ( Site 3108)
Natal, Rio Grande do Norte, Brazil
- Study Coordinator · Contact+5584991425228
RecruitingInstituto Nacional de Câncer - INCA ( Site 3107)
Rio de Janeiro, Brazil
- Study Coordinator · Contact+552132072964
RecruitingSunnybrook Research Institute ( Site 0203)
Toronto, Ontario, Canada
- Study Coordinator · Contact4164807802
RecruitingPrincess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, Canada
- Study Coordinator · Contact4169462000
RecruitingCentre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)
Montreal, Quebec, Canada
- Study Coordinator · Contact514-890-8000
Recruiting- Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0205)
Sherbrooke, Quebec, Canada
- Study Coordinator · Contact819 346-1110
RecruitingFundación Arturo López Pérez ( Site 3300)
Santiago, Region M. de Santiago, Chile
- Study Coordinator · Contact+56227067543
RecruitingPontificia Universidad Catolica de Chile ( Site 3307)
Santiago, Region M. de Santiago, Chile
- Study Coordinator · Contact+56994945927
RecruitingBradfordhill ( Site 3301)
Santiago, Region M. de Santiago, Chile
- Study Coordinator · Contact56229490970
Recruiting- Recruiting
Sarawak General Hospital ( Site 0602)
Kuching, Sarawak, Malaysia
- Study Coordinator · Contact+6082276666
RecruitingPantai Hospital Kuala Lumpur ( Site 0603)
Kuala Lumpur, Malaysia
- Study Coordinator · Contact+60322960888
RecruitingUniversity Malaya Medical Centre ( Site 0601)
Kuala Lumpur, Malaysia
- Study Coordinator · Contact+60379492495
RecruitingInstituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 3405)
Concepción, Departamento de Junín, Peru
- Study Coordinator · Contact+51983582526
Recruiting- Recruiting
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)
Lima, Peru
- Study Coordinator · Contact+012241598
RecruitingInstituto Nacional de Enfermedades Neoplásicas ( Site 3401)
Lima, Peru
- Study Coordinator · Contact+5112016500
RecruitingNational Cancer Centre Singapore ( Site 0800)
Singapore, Central Singapore, Singapore
- Study Coordinator · Contact+6564368000
RecruitingInstitut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)
L'Hospitalet de Llobregat, Barcelona, Spain
- Study Coordinator · Contact34932607744
RecruitingCHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)
A Coruña, La Coruna, Spain
- Study Coordinator · Contact34981178353
RecruitingClinica Universitaria Navarra - Madrid ( Site 2004)
Madrid, Madrid, Comunidad de, Spain
- Study Coordinator · Contact34913531920/7513
RecruitingHospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)
Madrid, Madrid, Comunidad de, Spain
- Study Coordinator · Contact34913368263
RecruitingHOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)
Madrid, Spain
- Study Coordinator · Contact+34 609378523
RecruitingTaichung Veterans General Hospital ( Site 1004)
Taichung, Taiwan
- Study Coordinator · Contact886423592525x5822
RecruitingNational Cheng Kung University Hospital ( Site 1003)
Tainan, Taiwan
- Study Coordinator · Contact88662353535x6729
Recruiting- Recruiting
Faculty of Medicine Siriraj Hospital ( Site 1111)
Bangkok, Bangkok, Thailand
- Study Coordinator · Contact+6624141895
RecruitingChulalongkorn Hospital ( Site 1114)
Pathumwan, Bangkok, Thailand
- Study Coordinator · Contact+6622516704
Recruiting- Recruiting
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2201)
Adana, Turkey (Türkiye)
- Study Coordinator · Contact+905446726040
Recruiting- Recruiting
Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)
Edirne, Turkey (Türkiye)
- Study Coordinator · Contact+902842360909
RecruitingIstanbul Universitesi Cerrahpasa ( Site 2203)
Istanbul, Turkey (Türkiye)
- Study Coordinator · Contact0090 212 414 30 00
RecruitingKoc University, School of Medicine ( Site 2202)
Istanbul, Turkey (Türkiye)
- Study Coordinator · Contact0090 850 250 82 50
RecruitingUniversity Hospitals Sussex NHS Foundation Trust ( Site 2301)
East Sussex, Brighton And Hove, United Kingdom
- Study Coordinator · Contact01273 696955
RecruitingThe Royal Cornwall Hospital ( Site 2306)
Truro, Cornwall, United Kingdom
- Study Coordinator · Contact01872 256424
RecruitingSt Bartholomew's Hospital ( Site 2302)
London, London, City of, United Kingdom
- Study Coordinator · Contact+4402044656670
RecruitingUniversity College Hospital London ( Site 2303)
London, London, City of, United Kingdom
- Study Coordinator · Contact020 3456 7890
RecruitingGuy's & St Thomas' NHS Foundation Trust ( Site 2309)
London, London, City of, United Kingdom
- Study Coordinator · Contact+4402071881474
RecruitingWestern General Hospital ( Site 2307)
Edinburgh, Midlothian, United Kingdom
- Study Coordinator · Contact+441315371859
RecruitingQueen Elizabeth Hospital ( Site 2305)
Birmingham, United Kingdom
- Study Coordinator · Contact+4401213718771
RecruitingThe Christie NHS Foundation Trust ( Site 2300)
Manchester, United Kingdom
- Study Coordinator · Contact01614463746
Recruiting
Study team
Sponsor
Merck Sharp & Dohme LLC
Study ID 5684-015
Study director
Medical Director
Merck Sharp & Dohme LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.