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Study of MK-5684 compared to standard therapy in patients with breast cancer, ovarian cancer, or endometrial cancer

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What is this study about?

This clinical trial studies the effectiveness of MK-5684 (opevesostat) in treating specific types of solid tumors. The study focuses on three types of cancer: breast cancer that is hormone receptor-positive and HER2-negative, ovarian cancer including fallopian tube and peritoneal carcinoma, and endometrial cancer that is low-grade endometrioid. The purpose is to compare how well MK-5684 works compared to standard treatments in preventing cancer progression.

The study will test MK-5684 alongside several other medications that may be used as standard treatments, including tamoxifen, exemestane, letrozole, fulvestrant, megestrol, and medroxyprogesterone. Some participants may also receive medications to manage side effects, such as dexamethasone, hydrocortisone, and fludrocortisone.

During the study, participants will receive either MK-5684 or standard treatment medications. The study will track how long participants live without their cancer getting worse, their overall survival time, and how well they respond to treatment. Doctors will monitor participants for any side effects throughout the treatment period, which may last up to 60 months.

1 Initial assessment and group assignment

Your condition will be evaluated to determine eligibility for one of three groups: Cohort A (breast cancer), Cohort B (ovarian cancer), or Cohort C (endometrial cancer)

Medical tests will confirm your diagnosis and current health status

2 Treatment assignment

You will receive either MK-5684 or standard treatment based on your assigned group

If you are in Cohort A, you must have previously received at least one hormone therapy treatment

If you are in Cohort B, you must have completed 4-8 cycles of platinum-based chemotherapy

If you are in Cohort C, you may be new to treatment or have had up to one previous platinum-based therapy

3 Treatment period

Your treatment will continue from September 2025 until November 2027

Regular assessments will track how your tumor responds to treatment using imaging scans

Side effects will be monitored throughout the study period

Any previous treatment side effects must have improved to mild level or better before starting the study

4 Monitoring and follow-up

Regular checks will measure how long you remain without disease progression

Your overall survival will be tracked throughout the study

The study will record if you experience any side effects

The study will note if you need to stop treatment due to side effects

Who Can Join the Study?

  • Must be diagnosed with one of the following:
    • Hormone receptor positive/HER2 negative breast cancer that is either locally advanced and cannot be surgically removed, or has spread to other parts of the body
    • High-grade ovarian, fallopian tube, or peritoneal cancer (including specific types like serous, endometrioid, carcinosarcoma, or clear cell)
    • Low-grade endometrial cancer that is advanced or has returned
  • For breast cancer patients: Must have had disease progression during or after at least 1 hormone-based therapy for metastatic disease
  • For ovarian cancer patients: Must have received 4 to 8 cycles of platinum-based chemotherapy as third-line treatment
  • For endometrial cancer patients: Either never received treatment or had up to 1 course of platinum-based therapy
  • Must have recovered from side effects of previous cancer treatments to mild level or baseline condition
  • Can participate if HIV-positive, but must have well-controlled disease with antiretroviral therapy
  • Can participate with history of Hepatitis C if virus is undetectable in blood tests
  • Can participate with Hepatitis B if:
    • Have received antiviral therapy for at least 4 weeks
    • Have undetectable virus levels in blood

Who Cannot Join the Study?

  • Age below 18 years old
  • Pregnancy or currently breastfeeding
  • Active brain metastases (cancer that has spread to the brain) or brain involvement that is not stable
  • History of other cancers within the last 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart conditions including:
    • Heart attack within past 6 months
    • Unstable angina (chest pain)
    • Heart failure with symptoms
  • Active, uncontrolled infections requiring systemic treatment
  • Known HIV infection (Human Immunodeficiency Virus)
  • Active hepatitis B or C infection
  • Any condition that would make participating unsafe or could interfere with the study results
  • Current participation in other clinical trials or treatment with experimental drugs within 4 weeks before starting this study
  • Known allergies or severe reactions to similar medications
  • Significant liver or kidney problems

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Ivkxhyxi Ctxskp Dxpyuwyayetonldvs L'hospitalet De Llobregat Spain
Hhlmqrmx Udwukwanxqkpg dm A Cmedrp A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
15.09.2025

Trial locations

Investigated drugs:

MK-5684 is an investigational medication being studied for the treatment of various solid tumors. This medication is being compared to standard treatments to see how well it works in preventing cancer progression. The exact mechanism of how this medication works has not been fully described in the provided information.

Standard of Care (SOC) refers to the current best available treatments that are typically used for patients with solid tumors. These treatments vary depending on the specific type of cancer being treated.

Investigated diseases:

Breast cancer – A disease that begins when cells in the breast start to grow out of control, forming a tumor that can often be seen on an x-ray or felt as a lump. It occurs mostly in women but can also affect men. The cancer typically starts in either the ducts that carry milk or the glands that make milk. It can spread to surrounding breast tissue and potentially to other parts of the body.

Ovarian cancer – A disease where abnormal cells in the ovary begin to multiply out of control and form a tumor. It typically begins in the cells that cover the outer surface of the ovary. The disease process can cause the ovary to enlarge and affect its normal function. As the condition progresses, cancer cells can spread within the pelvis and abdomen.

Endometrial cancer – A disease that develops when cells in the endometrium (the inner lining of the uterus) begin to grow abnormally. It typically develops slowly over time, starting with an overgrowth of endometrial tissue. The abnormal cells can grow and multiply to form a tumor within the uterus. Most cases occur in women after menopause.

Trial ID:
2024-519563-18-00
Protocol code:
MK-5684-015
Trial Phase:
Therapeutic use (Phase IV)

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