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
Research Team
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