Tests MK-5684 against standard treatment in certain solid tumors
Tests MK-5684 against standard care in adults with breast, ovarian or endometrial cancer.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- A Coruña, L'Hospitalet de Llobregat, Madrid, and Pozuelo de Alarcón, SpainSee the 5 sites
- Trial code
- EU 2024-519563-18-00
- U1111-1315-5430
- Registry title
- A clinical study of MK-5684 in people with certain solid tumors (MK-5684-015)
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 22 people, planned
- Started
- 2 Sept 2025
- Expected to end
- 4 Nov 2027
- Type of study
- Interventional
- Record updated
- 28 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with certain advanced solid tumors: hormone receptor positive/HER2 negative breast cancer, high-grade ovarian-type cancer, or low-grade endometrioid endometrial cancer.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Cohort A: hormone receptor positive/HER2 negative breast cancer that cannot be removed by surgery or has spread, and cannot be treated with the aim of removing all of the disease. Cohort B: high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer. Cohort C: advanced or recurrent low-grade endometrioid endometrial cancer.
- Earlier treatment
- Cohort A: disease got worse after at least 1 endocrine-based therapy for metastatic disease (1 line of a protocol-specified combination, or 2 or more lines). Cohort B: 4 to 8 cycles of platinum-based doublet chemotherapy in third-line setting. Cohort C: no treatment before, or up to 1 earlier line of platinum-based therapy. Side effects of earlier treatment must have recovered to Grade 1 or baseline.
- Biomarker or test result
- Cohort A: hormone receptor positive and HER2 negative tumor. People with HIV must have it well controlled on antiretroviral therapy. Hepatitis B or C must have an undetectable viral load.
Main reasons for not taking part
- Past or current adrenal insufficiency, or known or suspected adrenal metastases
- Known active brain metastases or cancer cells in the fluid around the brain and spinal cord
- Another cancer that is getting worse or needed treatment in the past 3 years
- History of stem cell or solid organ transplant
- Cohort B: platinum-resistant or platinum-refractory ovarian cancer
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- (Cohort A) Has a diagnosis of hormone receptor positive/Human Epidermal Growth Factor Receptor 2 negative 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
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- (Cohort A) 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
- (Cohort B) Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line 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)
- (Cohort C) Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced/metastatic OR adjuvant/neoadjuvant setting
- 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
Who cannot take part
- (Cohort A) Breast cancer amenable to treatment with curative intent
- Has any prior history or current condition of adrenal insufficiency
- 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 not adequately recovered from major surgery or has ongoing surgical complications
- (Cohorte B)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)
- (Cohorte C) Is a candidate for curative-intent surgery or curative-intent radiotherapy
- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has a history of stem cell/solid organ transplant
- (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
- (Cohort B) Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer
- Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications
- Has known active central nervous system metastases and/or carcinomatous meningitis
- (Cohort A) 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 C) Has high-grade (FIGO Grade 3 or poorly differentiated) endometroid 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
- Has confirmed or suspected adrenal metastases
Where in Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
- Clinica Universidad de NavarraMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainTaking people
About the trial
What the trial wants to find out
To evaluate MK-5684 versus standard of care (SOC) with respect to progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with selected solid tumors (All Cohorts).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)
- Plain-language title
- Tests MK-5684 against standard treatment in certain solid tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 28 September 2026