Study of trastuzumab deruxtecan with bevacizumab versus bevacizumab alone as first-line maintenance treatment for patients with HER2-expressing ovarian cancer
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.
1Initial 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
2Previous 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
3Treatment assignment
You will be randomly assigned to one of two treatment groups:
Group A: Trastuzumab deruxtecan combined with bevacizumab
Group B: Bevacizumab alone
4Treatment 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
5Monitoring 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
6Study 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 Study?
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 Study?
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
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.
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.
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