Actively Recruiting
A Phase 2 Open-label Study of MK-5684 in People With Selected Solid Tumors Including Breast, Ovarian, and Endometrial Cancer (OMAHA-015)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-13
250
Participants Needed
55
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying if MK-5684, a medicine that blocks steroid hormone production, can treat breast cancer, ovarian cancer, and endometrial cancer. The study compares MK-5684 with standard treatments to see if it helps people live longer without their cancer growing or spreading. This is a Phase 2 trial focusing on specific solid tumors including hormone receptor positive breast cancer, high-grade ovarian cancer, and low-grade endometrial cancer. Participants with breast cancer will receive 5 mg of MK-5684 twice daily along with fludrocortisone and dexamethasone tablets adjusted as needed. Breast cancer participants may also receive endocrine therapy such as fulvestrant or exemestane. Those with ovarian cancer will be observed without treatment during the study. Participants with endometrial cancer will receive physician-selected treatments including megestrol acetate, tamoxifen, or letrozole. Treatments continue until specific stopping conditions are met. During the study, participants will be monitored for cancer progression and survival up to about two years. Researchers will assess how long participants live without their cancer worsening and overall survival. They will also track response to treatment, clinical benefit, and adverse events. This includes regular clinic visits, assessments, and safety monitoring to understand how well MK-5684 works compared to other treatments. The trial is expected to last until late 2027.
CONDITIONS
Brief Title
A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with HR+/HER2- invasive breast cancer that is unresectable or metastatic and progressed after prior endocrine therapy (Cohort A)
- Histologically confirmed high-grade epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with prior platinum-based chemotherapy (Cohort B)
- Histologically confirmed primary advanced or recurrent low-grade endometrioid carcinoma, treatment naive or with limited prior platinum therapy (Cohort C)
- Recovered to Grade 1 or baseline from adverse events of previous cancer therapies
- Well-controlled HIV infection on antiretroviral therapy
- Hepatitis B positive participants must have received antiviral therapy for at least 4 weeks and have undetectable viral load
- Hepatitis C participants must have undetectable viral load
- Adults aged 18 years or older
You will not qualify if you...
- Breast cancer amenable to curative treatment or with rapidly progressing symptomatic visceral metastases (Cohort A)
- Nonepithelial, borderline, low-grade serous, or mucinous ovarian tumors; platinum-resistant or refractory ovarian cancer; candidates for curative surgery or radiotherapy (Cohort B)
- High-grade or nonendometrioid endometrial carcinoma; uterine mesenchymal tumors; candidates for curative surgery or radiotherapy (Cohort C)
- Confirmed or suspected adrenal metastases
- Difficulty swallowing or absorbing oral medications
- History or current adrenal insufficiency
- HIV with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Received live or live-attenuated vaccine within 30 days before starting study
- Additional progressing malignancy requiring treatment within past 3 years
- Known active central nervous system metastases or carcinomatous meningitis
- History of stem cell or solid organ transplant
- Not recovered from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive study treatments according to their assigned cohort until discontinuation criteria are met.
Regular visits as per study schedule during treatment
Trial Site Locations
Total: 55 locations
1
Alaska Womens Cancer Care ( Site 0037)
Anchorage, Alaska, United States, 99508
Actively Recruiting
2
Mount Sinai Cancer Center ( Site 0009)
Miami Beach, Florida, United States, 33140
Actively Recruiting
3
TRIALS 365 ( Site 0022)
Shreveport, Louisiana, United States, 71103
Actively Recruiting
4
Mary Lanning Healthcare ( Site 0019)
Hastings, Nebraska, United States, 68901
Actively Recruiting
5
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center ( Site 0002)
New York, New York, United States, 10065
Actively Recruiting
7
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)
Columbus, Ohio, United States, 43210
Actively Recruiting
8
Baylor College of Medicine Medical Center ( Site 0004)
Houston, Texas, United States, 77030
Actively Recruiting
9
Mays Cancer Center ( Site 0039)
San Antonio, Texas, United States, 78229
Actively Recruiting
10
Hospital Aleman ( Site 0301)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT
Actively Recruiting
11
Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)
Buenos Aires, Buenos Aires F.D., Argentina, C1118AAT
Actively Recruiting
12
Instituto Alexander Fleming ( Site 0303)
Buenos Aires, Buenos Aires F.D., Argentina, C1426ANZ
Actively Recruiting
13
Hospital Santa Rita de Cassia ( Site 3104)
Vitória, Espírito Santo, Brazil, 29043-260
Actively Recruiting
14
Obras Sociais Irma Dulce ( Site 3112)
Salvador, Estado de Bahia, Brazil, 41680-430
Actively Recruiting
15
Hospital Felicio Rocho ( Site 3105)
Belo Horizonte, Minas Gerais, Brazil, 30110-934
Actively Recruiting
16
Hospital de Cancer de Pernambuco ( Site 3103)
Recife, Pernambuco, Brazil, 50040-000
Actively Recruiting
17
Liga Norte Riograndense Contra o Cancer ( Site 3108)
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
18
Instituto Nacional de Câncer - INCA ( Site 3107)
Rio de Janeiro, Brazil, 20230-130
Actively Recruiting
19
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
20
FALP ( Site 3300)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
21
Pontificia Universidad Catolica de Chile ( Site 3307)
Santiago, Region M. de Santiago, Chile, 8330032
Actively Recruiting
22
Bradfordhill ( Site 3301)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
23
ONCOCENTRO APYS ( Site 3302)
Viña del Mar, Valparaiso, Chile, 2520598
Actively Recruiting
24
Sarawak General Hospital ( Site 0602)
Kuching, Sarawak, Malaysia, 93586
Actively Recruiting
25
Pantai Hospital Kuala Lumpur ( Site 0603)
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
26
University Malaya Medical Centre ( Site 0601)
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
27
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 3405)
Concepción, Departamento de Junín, Peru, 12125
Actively Recruiting
28
Clínica San Antonio ( Site 3404)
Trujillo, La Libertad, Peru, 13008
Actively Recruiting
29
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)
Lima, Peru, 15036
Actively Recruiting
30
Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)
Lima, Peru, 15038
Actively Recruiting
31
National Cancer Centre Singapore ( Site 0800)
Singapore, Central Singapore, Singapore, 168583
Actively Recruiting
32
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
33
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)
A Coruña, La Coruna, Spain, 15006
Actively Recruiting
34
Clinica Universitaria Navarra - Madrid ( Site 2004)
Madrid, Madrid, Comunidad de, Spain, 28027
Actively Recruiting
35
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
36
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)
Madrid, Spain, 28223
Actively Recruiting
37
Taichung Veterans General Hospital ( Site 1004)
Taichung, Taiwan, 407
Actively Recruiting
38
National Cheng Kung University Hospital ( Site 1003)
Tainan, Taiwan, 704
Actively Recruiting
39
Mackay Memorial Hospital ( Site 1002)
Taipei, Taiwan, 10449
Actively Recruiting
40
Chulalongkorn Hospital ( Site 1114)
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
41
Faculty of Medicine Siriraj Hospital ( Site 1111)
Bangkok, Bangkok, Thailand, 10700
Actively Recruiting
42
Songklanagarind Hospital ( Site 1113)
Songkhla, Thailand, 90110
Actively Recruiting
43
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2201)
Adana, Turkey (Türkiye), 01240
Actively Recruiting
44
Hacettepe Universitesi ( Site 2200)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
45
Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)
Edirne, Turkey (Türkiye), 22030
Actively Recruiting
46
Istanbul Universitesi Cerrahpasa ( Site 2203)
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
47
Koc University, School of Medicine ( Site 2202)
Istanbul, Turkey (Türkiye), 34450
Actively Recruiting
48
University Hospitals Sussex NHS Foundation Trust ( Site 2301)
East Sussex, Brighton And Hove, United Kingdom, BN2 1ES
Actively Recruiting
49
The Royal Cornwall Hospital ( Site 2306)
Truro, Cornwall, United Kingdom, TR1 3LJ
Actively Recruiting
50
St Bartholomew's Hospital ( Site 2302)
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
51
University College Hospital London ( Site 2303)
London, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
52
Guy's & St Thomas' NHS Foundation Trust ( Site 2309)
London, London, City of, United Kingdom, SE1 9RT
Actively Recruiting
53
Western General Hospital ( Site 2307)
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Actively Recruiting
54
Queen Elizabeth Hospital ( Site 2305)
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
55
The Christie NHS Foundation Trust ( Site 2300)
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
T
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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