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Study of trastuzumab deruxtecan with bevacizumab versus bevacizumab alone as first-line maintenance treatment for patients with HER2-expressing ovarian 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 study focuses on ovarian cancer, specifically examining treatments for patients with HER2-expressing forms of the disease. The research evaluates two medications: trastuzumab deruxtecan (also known as DS-8201a) in combination with bevacizumab, compared to bevacizumab alone. These medications are given through an intravenous infusion, which means they are administered directly into a vein.

The purpose of this research is to determine if using these two medications together is more effective than using bevacizumab by itself in treating ovarian cancer. The study specifically looks at patients who have recently been diagnosed with advanced stages of the disease. Both medications are types of targeted therapy - bevacizumab works by affecting blood vessel growth in tumors, while trastuzumab deruxtecan is an antibody-drug conjugate that specifically targets cancer cells expressing the HER2 protein.

During the study, patients will receive treatment for up to 24 months. The medications will be given through regular infusions at specified intervals. Throughout the treatment period, doctors will monitor patients' responses to the therapy and track any changes in their condition. This research is particularly focused on patients whose cancer shows specific levels of a protein called HER2 on their tumor cells.

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

    Initial assessment and testing

    Your tissue sample will be tested for HER2 protein expression by a central laboratory

    Local testing will be performed to check your HRD (Homologous Recombination Deficiency) or BRCA gene status

  2. Step 2

    Previous treatment confirmation

    You must have completed up to 6 cycles of bevacizumab with platinum-based chemotherapy

    Your doctor will confirm that you are eligible to continue with bevacizumab maintenance treatment

  3. Step 3

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group A: Trastuzumab deruxtecan combined with bevacizumab

    Group B: Bevacizumab alone

  4. Step 4

    Treatment administration

    Both medications will be given through an intravenous infusion (directly into your vein)

    Treatment will continue until your disease shows progression or other stopping criteria are met

  5. Step 5

    Monitoring and assessment

    Regular imaging scans will be performed to check your response to treatment

    Your scans will be reviewed by both your doctor and independent experts

    Your overall health status will be monitored throughout the study

  6. Step 6

    Study duration

    The study is planned to run from late 2025 through December 2031

    Your participation duration will depend on how your body responds to the treatment

Who can join the trial?

8 criteria

  • Must be 18 years or older and able to provide informed consent for study participation
  • Must be female with confirmed diagnosis of high-grade epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (including types like serous, endometrioid, clear cell, carcinosarcoma, mucinous)
  • Must have newly diagnosed Stage III or IV cancer (FIGO staging system - a method doctors use to determine how advanced the cancer is)
  • Must have specific levels of HER2 protein expression (a protein that can be found on cancer cells) confirmed by laboratory testing
  • Must have adequate tumor tissue samples available for laboratory testing of HER2 and HRD status (HRD refers to the ability of cancer cells to repair DNA damage)
  • Must have results available from HRD or BRCA testing (tests that look for specific genetic changes in cancer cells)
  • Must have received standard treatment with bevacizumab (a cancer medication) combined with platinum-based chemotherapy and be eligible to continue bevacizumab alone
  • Must have completed up to 6 cycles of bevacizumab with platinum-based chemotherapy as initial treatment

Who cannot join the trial?

15 criteria

  • Women who are pregnant or breastfeeding
  • Patients with active brain metastases (cancer that has spread to the brain)
  • Patients with significant heart conditions, including heart failure or poorly controlled high blood pressure
  • Those with severe liver problems
  • Patients who have received certain types of cancer treatments within the last 4 weeks
  • Those with known allergies to the study medications
  • Patients with active, uncontrolled infections
  • Those who have participated in another clinical trial within the past 28 days
  • Patients with severe kidney problems
  • Those with a history of other cancers within the past 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Patients who cannot undergo regular MRI or CT scans
  • Those with certain blood disorders that could increase risks during treatment
  • Patients with poorly controlled diabetes
  • Those unable to swallow oral medications
  • Patients with active autoimmune conditions requiring systemic treatment
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Investigated drugs

  • Trastuzumab Deruxtecan (T-DXd)

    is a medication specifically designed to target cancer cells that express high levels of a protein called HER2. It combines an antibody that attaches to HER2 with a chemotherapy drug, delivering the treatment directly to cancer cells. This targeted approach helps to kill cancer cells while potentially reducing effects on healthy cells.

  • Bevacizumab

    is a medication that works by blocking the formation of new blood vessels that feed tumors. By preventing tumors from developing their own blood supply, this medication can help slow or stop tumor growth. It's commonly used in various types of cancer treatment, including ovarian cancer.

What is already known about the treatment

  • Trastuzumab Deruxtecan (T-DXd)

    An antibody-drug conjugate administered through intravenous infusion, specifically designed to target HER2-expressing cancer cells. This medication combines a HER2-targeted antibody with a potent chemotherapy drug, delivering the cancer-fighting agent directly to tumor cells while potentially minimizing damage to healthy tissues. Currently used in clinical trials for ovarian cancer treatment, it represents an innovative approach in targeted cancer therapy.

  • Bevacizumab

    A monoclonal antibody medication administered through intravenous infusion that works by blocking blood vessel formation in tumors, effectively cutting off their blood supply and inhibiting growth. This anti-angiogenic agent is well-established in cancer treatment and has shown effectiveness in various cancer types, including ovarian cancer. It belongs to the class of vascular endothelial growth factor (VEGF) inhibitors and is commonly used both as a single agent and in combination therapy.

Investigated diseases

Ovarian Cancer - A disease that begins in the ovaries, which are the female reproductive organs that produce eggs. It develops when abnormal cells in the ovaries begin to multiply uncontrollably and form a tumor. The cancer can spread from its original site to other parts of the body, particularly within the pelvis and abdomen. As the disease progresses, it can affect nearby organs and tissues. The condition may develop in one or both ovaries, which are located on either side of the uterus.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516982-35-00Protocol codeDS8201-772Estimated enrolment582 patientsSponsorDaiichi Sankyo Inc.

sourced from the EU Clinical Trials Register and site verification

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