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Study on the Effectiveness of Durvalumab, Olaparib, and Bevacizumab in Patients with Newly Diagnosed Advanced 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 the treatment of advanced ovarian cancer, specifically in patients who have been newly diagnosed with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study involves the use of several medications, including durvalumab, olaparib, and bevacizumab. Durvalumab, also known by its code name MEDI4736, is a type of medication that helps the immune system fight cancer. Olaparib, also referred to as AZD2281, is a medication that targets cancer cells with specific genetic mutations. Bevacizumab is a medication that inhibits the growth of blood vessels that supply nutrients to tumors.

The purpose of this study is to evaluate the effectiveness and safety of these medications when used in combination with standard chemotherapy. The study is designed to compare different treatment approaches: one group will receive standard chemotherapy and bevacizumab, followed by maintenance therapy with bevacizumab alone, while other groups will receive additional treatments with durvalumab or a combination of durvalumab and olaparib. The study is conducted in a randomized and double-blind manner, meaning that participants are randomly assigned to different treatment groups, and neither the participants nor the researchers know which treatment each participant is receiving.

Participants in the study will undergo a series of treatments over a period of time, with regular monitoring to assess the progression of the disease and the response to the treatment. The study aims to determine how well these treatments work in preventing the cancer from getting worse and to evaluate the overall survival of the participants. The trial will also look at other factors such as the duration of response to the treatment and the quality of life of the participants. The study is expected to continue until 2026, with the goal of providing valuable information on the treatment of advanced ovarian cancer.

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

    Joining the study

    Upon joining the study, the patient is randomly assigned to one of the treatment groups. This process is double-blind, meaning neither the patient nor the researchers know which group the patient is in.

  2. Step 2

    Initial treatment phase

    The patient receives standard chemotherapy combined with bevacizumab. Bevacizumab is administered through an intravenous infusion. The frequency and dosage are determined by the study protocol and the patient's specific needs.

  3. Step 3

    Maintenance therapy

    After completing the initial treatment phase, the patient enters the maintenance therapy phase. This involves continued treatment with bevacizumab and may include additional medications such as durvalumab and olaparib.

    Durvalumab is given as an intravenous infusion, while olaparib is taken orally in the form of film-coated tablets. The dosage and frequency are specified by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's health and response to treatment are closely monitored. This includes regular medical assessments and tests to evaluate the effectiveness and safety of the treatment.

    The study aims to measure progression-free survival, which is the time from the start of the study until the disease progresses or the patient passes away.

  5. Step 5

    End of study participation

    The patient's participation in the study concludes either at the end of the study period or if the patient decides to withdraw from the study. The estimated end date for the study is March 17, 2026.

Who can join the trial?

8 criteria

  • Female patients with newly diagnosed advanced ovarian cancer, which includes specific types like high grade serous, high grade endometrioid, clear cell ovarian cancer, carcinosarcoma, primary peritoneal cancer, or fallopian-tube cancer.
  • Patients must be at least 18 years old.
  • Patients should be candidates for surgery to remove as much of the tumor as possible, either before starting treatment or after some initial chemotherapy.
  • Patients must provide a sample of their tumor for specific genetic testing called tBRCA testing.
  • There must be evidence showing whether or not there is a BRCA1/2 mutation in the tumor tissue. BRCA1/2 are genes that, when mutated, can affect cancer risk.
  • Patients should have an ECOG performance status of 0-1, which means they are fully active or have some symptoms but can still carry out light work.
  • Patients must have normal functioning of their organs and bone marrow, which is important for overall health and ability to handle treatment.
  • Women who can have children must show they are not pregnant, either by being postmenopausal or having a negative pregnancy test.

Who cannot join the trial?

6 criteria

  • Patients who have not been newly diagnosed with advanced ovarian, fallopian, or primary peritoneal cancer.
  • Patients who do not have high-grade epithelial cancer, which is a type of cancer that starts in the cells on the surface of the ovary, fallopian tube, or peritoneum.
  • Patients who are not in FIGO stage III-IV, which means the cancer is not advanced or has not spread beyond the pelvis.
  • Patients who are not female, as the study is only for women.
  • Patients who are not in the specified age range for the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the immune system attack cancer cells. It is a type of immunotherapy that works by blocking a protein that stops the immune system from working properly, allowing it to better fight the cancer.

  • Bevacizumab

    is a medication that helps to prevent the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, it can help to slow down or stop the growth of the cancer.

  • Olaparib

    is a medication that targets cancer cells with specific genetic defects. It works by interfering with the cancer cells' ability to repair their DNA, which can lead to the death of these cells. This medication is used as part of the maintenance therapy in the trial to help keep the cancer from coming back after initial treatment.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced ovarian cancer. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, durvalumab allows the immune system to better recognize and attack cancer cells. It is classified as a monoclonal antibody.

  • Bevacizumab

    Bevacizumab is given through an intravenous infusion and is used in combination with other treatments for advanced ovarian cancer. It works by inhibiting the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. This medication is classified as an angiogenesis inhibitor and is well-documented in medical literature for its role in cancer therapy.

  • Olaparib

    Olaparib is taken orally in pill form and is used as a maintenance therapy for certain types of ovarian cancer. It functions by inhibiting an enzyme called PARP, which helps repair DNA damage in cells. By blocking this enzyme, olaparib prevents cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor and is recognized in medical literature for its effectiveness in treating cancers with specific genetic mutations.

Investigated diseases

  • High Grade Epithelial Ovarian Cancer

    This is a type of cancer that begins in the cells on the surface of the ovary. It is characterized by its rapid growth and tendency to spread to other parts of the body, often being diagnosed at an advanced stage. The disease progresses as cancer cells multiply and invade nearby tissues, potentially spreading to the abdominal lining and other organs. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. The progression of the disease can lead to the accumulation of fluid in the abdomen and other complications. Early detection is challenging due to the subtlety of initial symptoms.

  • Fallopian Tube Cancer

    This rare cancer originates in the fallopian tubes, which connect the ovaries to the uterus. It often presents with symptoms similar to ovarian cancer, such as pelvic pain and abnormal vaginal discharge. The disease progresses as cancer cells grow and may spread to nearby organs and tissues. It is typically diagnosed at an advanced stage due to the lack of specific early symptoms. The cancer can cause blockages in the fallopian tubes, leading to further complications. As it advances, it may spread to the abdominal cavity and beyond.

  • Primary Peritoneal Cancer

    This cancer develops in the peritoneum, the lining of the abdominal cavity, and is closely related to ovarian cancer. It progresses similarly to ovarian cancer, with cancer cells spreading across the peritoneal surface. Symptoms can include abdominal pain, bloating, and digestive disturbances. The disease often advances before being detected, as early symptoms are non-specific. It can lead to the accumulation of fluid in the abdomen, known as ascites. The cancer may spread to other abdominal organs and tissues as it progresses.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502747-35-00Protocol codeDUO-O/D081RC00001Estimated enrolment1 407 patientsSponsorAstraZeneca AB

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