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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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 trial?

11 criteria

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 trial?

14 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario De Navarra
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Pamplona, Spain
Hospital Universitario Quironsalud Madrid
Verified
Pozuelo De Alarcon, Spain
Hospital Universitario da A Coruna
Verified
A Coruna Galicia, Spain

Trial locations

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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.

What is already known about the treatment

MK-5684 - An investigational drug currently being studied in clinical trials for the treatment of various solid tumors, particularly breast cancer, ovarian cancer, and endometrial cancer. The medication is being evaluated in a Phase 2 basket study to assess its effectiveness compared to standard of care treatments, with a primary focus on measuring progression-free survival in cancer patients. While the specific molecular mechanism of action is not publicly disclosed in the current trial data, this experimental therapy represents a new approach in oncology research targeting multiple types of solid tumors. The study is being conducted across multiple medical centers to evaluate the drug's safety and efficacy in treating these specific types of cancer.

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.