Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase2

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06979596

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Opevesostat (drug), Fludrocortisone/ Fludrocortisone acetate (drug), Dexamethasone/Dexamethasone acetate (drug), Rescue Medications (drug)
How long the study runs
Study runs about 27 months (dates as stated)
About the drug or intervention
Opevesostat — drug: Tablet for oral administration. · Fludrocortisone/ Fludrocortisone acetate — drug: Tablet for oral administration. · Dexamethasone/Dexamethasone acetate — drug: Tablet for oral administration. · Rescue Medications — drug: Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication. · Fulvestrant — drug: Administered via intramuscular injection. · Exemestane — drug: Tablet for oral administration. · Megestrol acetate/Medroxyprogesterone acetate — drug: Tablet for oral administration. · Tamoxifen — drug: Tablet for oral administration. · Letrozole — drug: Tablet for oral administration.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
250
Started
2025-08-11
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for malignant neoplasm
  • • Phase2 - 250 participants
  • • Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with malignant neoplasm

Where?

  • • East Sussex - University Hospitals Sussex NHS Foundation Trust ( Site 2301)
  • • Truro - The Royal Cornwall Hospital ( Site 2306)
  • • London - St Bartholomew's Hospital ( Site 2302)
  • • London - University College Hospital London ( Site 2303)
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Malignant Neoplasm

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2receptor positiveReceptor 2 negativeantigen positive

Treatment history

Treatments you must have had:

  • ✓ of platinum-based therapy in either the advanced/metastatic
  • ✓ recovered to ≤Grade 1 or baseline
  • ✓ well controlled HIV on antiretroviral therapy

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Cohort A:
  • ✓Cohort B:
  • ✓Has received between 4 to 8 cycles of platinum-based doublet drug treatment in third-line (3L) setting for ovarian cancer.
  • ✓Cohort C:

Who cannot take part

  • ✗The main exclusion criteria include but are not limited to the following:
  • ✗Cohort A:
  • ✗Breast cancer amenable to treatment with curative intent.
  • ✗Cohort B:
  • ✗Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.
See the full criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Cohort A: * 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 * 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. * Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line (3L) 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). * Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced/metastatic OR adjuvant/neoadjuvant setting. * All Cohorts : * 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. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Cohort A: * 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. * 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. * 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. * Cohort C: * 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. * All Cohorts: * 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.

Where Is This Study? (8 UK sites)

University Hospitals Sussex NHS Foundation Trust ( Site 2301)

East Sussex BN2 1ES, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01273 696955

The Royal Cornwall Hospital ( Site 2306)

Truro TR1 3LJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01872 256424

St Bartholomew's Hospital ( Site 2302)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4402044656670

University College Hospital London ( Site 2303)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 3456 7890

Guy's & St Thomas' NHS Foundation Trust ( Site 2309)

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4402071881474

Western General Hospital ( Site 2307)

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441315371859

Queen Elizabeth Hospital ( Site 2305)

Birmingham B15 2GW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4401213718771

The Christie NHS Foundation Trust ( Site 2300)

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01614463746

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10