Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06979596

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

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-13

250

Participants Needed

55

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • For Cohort A: Diagnosed with hormone receptor positive/HER2-negative invasive breast cancer that is locally advanced or metastatic and not curable by surgery
  • For Cohort A: Experienced disease progression after at least one prior endocrine therapy in metastatic setting
  • For Cohort B: Histologically confirmed high-grade epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
  • For Cohort B: Received 4 to 8 cycles of platinum-based chemotherapy in third-line setting for ovarian cancer
  • For Cohort C: Diagnosed with low-grade endometrioid carcinoma, either primary advanced or recurrent
  • For Cohort C: Treatment naive or received up to one prior line of platinum-based therapy
  • All cohorts: Recovered to Grade 1 or baseline from side effects of previous anticancer therapies
  • All cohorts: HIV-infected participants must have well-controlled HIV on antiretroviral therapy
  • All cohorts: Participants with Hepatitis B or C must have undetectable viral load after treatment
Not Eligible

You will not qualify if you...

  • For Cohort A: Breast cancer that can be treated with curative intent
  • For Cohort A: Advanced symptomatic visceral spread with life-threatening risks
  • For Cohort B: Nonepithelial cancers, borderline tumors, low-grade serous or endometrioid cancers, and other specified ovarian cancer types
  • For Cohort B: Platinum-resistant or refractory ovarian cancer
  • For Cohort B: Candidates for curative surgery or radiotherapy for ovarian cancer
  • For Cohort C: High-grade or nonendometrioid carcinoma and other specified uterine tumors
  • For Cohort C: Candidates for curative surgery or radiotherapy
  • All cohorts: Confirmed or suspected adrenal metastases
  • All cohorts: Difficulty swallowing oral medications or conditions impairing absorption
  • All cohorts: History or current adrenal insufficiency
  • All cohorts: HIV with history of Kaposi's sarcoma or Multicentric Castleman's Disease
  • All cohorts: Received live vaccine within 30 days before study intervention
  • All cohorts: Additional progressing malignancy requiring treatment within past 3 years
  • All cohorts: Active central nervous system metastases or carcinomatous meningitis
  • All cohorts: History of stem cell or solid organ transplant
  • All cohorts: Not recovered from major surgery or ongoing surgical complications

AI-Screening

AI-Powered Screening

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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

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Research Team

T

Toll Free Number

CONTACT

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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