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Study of Sacituzumab Tirumotecan and Bevacizumab for Patients with Recurrent Ovarian Cancer

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What is this trial about?

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

This clinical trial is focused on studying treatments for ovarian cancer, specifically in cases where the cancer has returned after initial treatment. The study will explore the effectiveness and safety of a treatment called sacituzumab tirumotecan, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins designed to target specific substances in the body. In this study, sacituzumab tirumotecan will be used alone or in combination with another medication called bevacizumab, which is also a monoclonal antibody that helps prevent the growth of blood vessels that feed tumors.

The purpose of the study is to evaluate how well these treatments work in maintaining the health of patients with platinum-sensitive recurrent ovarian cancer. This means the cancer has responded to platinum-based chemotherapy in the past but has come back. The study will compare the effects of sacituzumab tirumotecan with or without bevacizumab against the standard care, which may include observation or the use of bevacizumab. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein.

The study will be conducted in two parts. The first part will focus on assessing the safety and how well patients tolerate the treatment. The second part will compare the effectiveness of the treatments in preventing the cancer from getting worse. The study will last for a period of up to 84 days, during which participants will be closely monitored for any side effects and the overall impact on their health. The goal is to find out if these treatments can help improve the quality of life and extend the time patients remain free from cancer progression.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate.

    You will undergo initial assessments to confirm eligibility, including a review of your medical history and current health status.

  2. Step 2

    Part 1: treatment initiation

    In this phase, you will receive the study medication sacituzumab tirumotecan through an intravenous infusion. This means the medication will be administered directly into your vein.

    You will also receive bevacizumab through an intravenous infusion. The frequency and dosage will be determined by the study team based on your specific needs.

  3. Step 3

    Part 1: monitoring and assessment

    Throughout this phase, your health will be closely monitored to evaluate the safety and tolerability of the treatment. This includes regular check-ups and tests.

    You will be asked to report any side effects or changes in your health to the study team.

  4. Step 4

    Part 2: treatment continuation or adjustment

    Depending on your response to the initial treatment, you may continue with sacituzumab tirumotecan with or without bevacizumab, or you may be observed with or without bevacizumab.

    The decision will be based on your health status and the study's objectives.

  5. Step 5

    Part 2: ongoing monitoring

    Your health will continue to be monitored regularly. This includes assessments of your overall survival and any side effects you may experience.

    You will be asked to complete questionnaires about your quality of life and physical functioning.

  6. Step 6

    Completion of the study

    At the end of the study, you will undergo a final assessment to evaluate your health and the effects of the treatment.

    You will receive information about the study's findings and any further steps regarding your health care.

Who can join the trial?

9 criteria

  • Must have a confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. These are types of cancer that affect the ovaries, the tubes connecting the ovaries to the uterus, or the lining of the abdomen.
  • Must have received at least 4 cycles of platinum-based chemotherapy in the first treatment and a total of 6 cycles of carboplatin-based chemotherapy in the second treatment for ovarian cancer.
  • Must have platinum-sensitive epithelial ovarian cancer, meaning the cancer responds well to platinum-based chemotherapy.
  • Must provide a sample of tumor tissue that has not been treated with radiation before.
  • If the participant has HIV (human immunodeficiency virus), it must be well controlled with medication.
  • If the participant has hepatitis B, they must have been treated with antiviral medication for at least 4 weeks and have no detectable virus in their blood before starting the study.
  • If the participant has a history of hepatitis C, the virus must not be detectable in their blood at the time of screening.
  • Must have an ECOG performance status of 0 to 1, which means the participant is fully active or has some symptoms but does not require bed rest for more than half of the day.
  • Must be female.

Who cannot join the trial?

3 criteria

  • Patients who do not have recurrent ovarian cancer cannot participate. This means the cancer has come back after treatment.
  • Only female patients can participate. Male patients are not eligible.
  • Patients who are part of a vulnerable population are not eligible. This generally refers to groups who may have difficulty giving informed consent or are at higher risk of being harmed.
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Investigated drugs

  • Sacituzumab Tirumotecan

    is a medication being studied for its potential to help treat ovarian cancer. It is designed to target and deliver a powerful anti-cancer drug directly to cancer cells, which may help to stop or slow down the growth of the cancer. In this trial, it is being used as a maintenance treatment, which means it is given to help keep the cancer from coming back after initial treatment.

  • Bevacizumab

    is a medication that works by blocking a protein called VEGF, which helps tumors grow new blood vessels. By stopping this process, bevacizumab can help to slow the growth of the cancer. In this trial, it is being used in combination with sacituzumab tirumotecan to see if it can improve the effectiveness of the treatment for ovarian cancer.

What is already known about the treatment

Sacituzumab Tirumotecan – Sacituzumab Tirumotecan is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating recurrent ovarian cancer, particularly after patients have undergone second-line platinum-based chemotherapy. The medication works by targeting and binding to specific proteins on cancer cells, delivering a toxic substance that helps kill these cells. It is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to specifically target cancer cells while minimizing damage to healthy cells.

Investigated diseases

Ovarian Cancer Recurrent – Ovarian cancer recurrent refers to the return of ovarian cancer after treatment. This disease originates in the ovaries, which are part of the female reproductive system. It typically begins with abnormal cell growth in the ovarian tissue, which can form a tumor. Over time, these cancerous cells can spread to nearby tissues and organs. The progression of recurrent ovarian cancer can vary, with some cases showing slow growth and others advancing more rapidly. Symptoms may include abdominal pain, bloating, and changes in bowel habits.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508015-23-00Protocol codeMK-2870-022Estimated enrolment480 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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