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Comparison of Niraparib alone versus Niraparib with Bevacizumab in patients with newly diagnosed advanced ovarian cancer after chemotherapy with carboplatin and paclitaxel

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What is this trial about?

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

This clinical trial focuses on patients with newly diagnosed advanced ovarian cancer, peritoneal cancer, or fallopian tube cancer. The study compares two treatment approaches using several medications. All patients will initially receive chemotherapy with carboplatin and paclitaxel, which are standard cancer drugs given through an intravenous infusion.

After the initial chemotherapy, patients will be divided into two groups. One group will receive a medication called niraparib alone, while the other group will receive niraparib combined with bevacizumab. Niraparib is taken as a capsule by mouth, while bevacizumab is given through an intravenous infusion. The purpose of this study is to determine if adding bevacizumab to niraparib treatment leads to better results than using niraparib alone.

The study will monitor how long patients remain without their cancer getting worse. Patients will receive regular medical examinations and tests throughout the study period. The treatment may continue for up to 36 months, depending on how well patients respond to the therapy and whether they experience any side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial chemotherapy phase

    You will receive a combination of paclitaxel and carboplatin through intravenous infusion

    During this phase, some patients will also receive bevacizumab through intravenous infusion

    The treatment will begin within 8 weeks after surgery

  2. Step 2

    Maintenance treatment phase

    After completing chemotherapy, you will receive niraparib capsules taken by mouth

    Some patients will continue receiving bevacizumab through intravenous infusion along with niraparib

    The specific treatment group will be determined randomly

  3. Step 3

    Regular monitoring

    Your health will be monitored through regular medical examinations

    Blood tests will check your liver and kidney function

    Blood pressure measurements will be taken regularly

    Imaging tests will be performed to assess the cancer's response to treatment

  4. Step 4

    Quality of life assessment

    You will be asked to complete questionnaires about your symptoms and quality of life

    These assessments help monitor how the treatment affects your daily life

  5. Step 5

    Long-term follow-up

    Your progress will be monitored until 2031

    Regular check-ups will continue to assess your response to treatment

    Any side effects or health changes will be documented and managed

Who can join the trial?

12 criteria

  • Must be female and at least 18 years old
  • Must have been diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer that has been confirmed through tissue examination
  • Must have either already had initial surgery or be planning to have chemotherapy followed by surgery
  • Must be able to start treatment within 8 weeks after surgery
  • Must have good physical function (able to carry out all normal activities with minimal limitations)
  • Must have a life expectancy of more than 3 months
  • Must have adequate blood test results showing: - Normal liver and kidney function - Good blood cell counts - Normal blood clotting ability
  • Must have normal blood pressure or well-controlled blood pressure (140/90 or lower)
  • Must provide a tissue sample for BRCA genetic testing
  • For women who can become pregnant: - Must have a negative pregnancy test - Must use highly effective birth control or remain abstinent during treatment and for 6 months after
  • Must be willing and able to: - Attend scheduled appointments - Follow treatment plans - Complete required laboratory tests - Fill out questionnaires
  • Must sign an informed consent form showing understanding of and willingness to participate in the study

Who cannot join the trial?

19 criteria

  • Prior chemotherapy, radiotherapy, hormonal therapy, immunotherapy, or any other systemic anti-cancer treatment for ovarian cancer
  • History of other cancers within the last 5 years (except successfully treated non-melanoma skin cancer or cervical carcinoma in situ)
  • Known brain metastases (cancer that has spread to the brain)
  • Significant cardiovascular disease, including:
    • Uncontrolled high blood pressure
    • Heart attack within past 6 months
    • Unstable angina (chest pain)
    • Severe heart rhythm problems
    • Major surgery within 4 weeks before starting treatment
    • Active bleeding or high risk of bleeding
    • Serious infections requiring antibiotics
    • Pregnancy or breastfeeding
    • Known allergies to any of the study medications
    • Inability to swallow oral medications
    • Serious medical conditions that could interfere with study participation
    • Thromboembolism (blood clots) within the past 6 months
    • Inadequate organ function, including:
      • Poor kidney function
      • Poor liver function
      • Low blood cell counts
      • Psychiatric disorders or conditions that would interfere with following study requirements
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Investigated drugs

  • Niraparib

    is a medication that belongs to a class of drugs called PARP inhibitors. It works by blocking an enzyme that cancer cells need to repair their DNA, which can help stop cancer cells from growing. It is taken as an oral medication and is used in the treatment of ovarian cancer.

  • Bevacizumab

    is a targeted therapy that works by blocking the formation of new blood vessels that feed tumors. It belongs to a class of drugs called angiogenesis inhibitors. This medication is given through an intravenous (IV) infusion and helps prevent tumors from growing by cutting off their blood supply.

  • Carboplatin

    is a chemotherapy medication that belongs to a group of drugs called platinum compounds. It works by interfering with cancer cell DNA, preventing cancer cells from dividing and growing. It is given through an intravenous (IV) infusion.

  • Paclitaxel

    is a chemotherapy medication that belongs to a class of drugs called taxanes. It works by stopping cancer cells from dividing and growing. This medication is given through an intravenous (IV) infusion and is commonly used in combination with other cancer treatments.

What is already known about the treatment

  • Niraparib

    A potent oral PARP (poly ADP-ribose polymerase) inhibitor administered in tablet form that works by preventing cancer cells from repairing their damaged DNA, leading to cell death. It is primarily used in the treatment of advanced ovarian, fallopian tube, and peritoneal cancers, particularly following platinum-based chemotherapy. This medication belongs to the class of targeted cancer therapy drugs and has shown significant effectiveness in clinical trials for maintaining treatment response in patients with these gynecologic cancers.

  • Bevacizumab

    An intravenously administered targeted therapy that functions as an angiogenesis inhibitor by blocking the formation of new blood vessels that supply tumors with nutrients and oxygen. It is commonly used in combination with other chemotherapy drugs for treating various cancers, including advanced ovarian cancer, and belongs to the class of monoclonal antibodies. This medication works by targeting and inhibiting vascular endothelial growth factor (VEGF), effectively starving tumors of their blood supply and inhibiting their growth.

  • Carboplatin

    A platinum-based chemotherapy drug administered intravenously that works by binding to and damaging cancer cell DNA, preventing cell division and leading to cell death. It is commonly used as a first-line treatment for ovarian cancer and belongs to the alkylating agents class of chemotherapy drugs. This medication is often preferred over similar platinum compounds due to its more manageable side effect profile while maintaining strong anti-cancer activity.

  • Paclitaxel

    An intravenously administered chemotherapy medication that works by stopping cancer cell division through stabilization of microtubules, essential cellular structures involved in cell division. It belongs to the taxane class of chemotherapy drugs and is commonly used in combination with carboplatin as a standard treatment for ovarian cancer. This medication has proven particularly effective in treating gynecologic cancers and is often used as part of first-line therapy.

Investigated diseases

  • Ovarian Cancer

    A disease that begins in the ovaries when cells start growing abnormally. It typically develops in the cells that make up the outer surface of the ovary. The cancer can spread within the pelvis and abdomen.

  • Peritoneal Cancer

    A rare cancer that develops in the peritoneum, the thin layer of tissue that lines the abdomen and covers most of the abdominal organs. It behaves similarly to ovarian cancer and produces similar symptoms.

  • Fallopian Tube Cancer

    A disease that begins in the fallopian tubes, which connect the ovaries to the uterus. The cancer starts in the cells of the fallopian tube lining and can spread to nearby organs. This type of cancer is closely related to ovarian cancer in terms of its behavior and characteristics.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516066-11-00Protocol codeAGO-OVAR 28Estimated enrolment970 patientsSponsorAGO Research GmbH

sourced from the EU Clinical Trials Register and site verification

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