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Study of Olaparib, Durvalumab and UV1 combination as maintenance treatment for patients with recurrent ovarian cancer who do not have BRCA mutations

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 clinical trial focuses on patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have completed chemotherapy treatment. The study evaluates the effectiveness of maintenance therapy using different combinations of medications. The main treatment medications include olaparib, durvalumab, and UV1, which are given to patients after their chemotherapy is finished.

The purpose of the study is to compare how well patients respond to treatment with olaparib alone versus a combination of olaparib, durvalumab, and UV1. Olaparib is taken as tablets by mouth, durvalumab is given through an intravenous infusion (through a vein), and UV1 is given as an injection under the skin. The medications work in different ways to help control the cancer - olaparib targets cancer cells directly, durvalumab helps the immune system fight cancer, and UV1 is designed to stimulate the body's immune response against cancer cells.

During the study, patients will be randomly assigned to receive either olaparib alone or the combination of all three medications. The treatment period can last up to 36 months, during which patients will have regular check-ups to monitor their health and how well the treatment is working. Throughout the study, doctors will track if the cancer stays under control and measure how long patients live without their cancer getting worse.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive treatment based on random assignment to one of the study groups (arms)

    The treatment begins within 10 weeks after completing your last platinum-containing chemotherapy

    Your doctor will confirm you have normal organ and bone marrow function before starting the treatment

  2. Step 2

    Treatment options

    Arm A: You will receive Lynparza (olaparib) tablets for oral use

    Arm B: Details not provided in source data

    Arm C: You will receive a combination of: Lynparza (olaparib) tablets taken by mouth, Imfinzi (durvalumab) given through intravenous infusion, and UV1 given as an injection under the skin

  3. Step 3

    Monitoring phase

    Your doctor will regularly check your condition using scans to measure how the disease responds to treatment

    Blood tests will be performed to monitor your organ function and blood count

    Your overall health status will be assessed during regular visits

  4. Step 4

    Follow-up assessments

    Regular evaluations will track your progress and any changes in your condition

    The study will monitor how long you remain without disease progression

    Additional assessments will track when you might need next treatments

    The study continues until 2030

Who can join the trial?

19 criteria

  • Must be 18 years or older
  • Must weigh more than 30 kilograms
  • Must be able to perform daily activities independently or with minimal assistance (ECOG status 0-1)
  • Must have a life expectancy of at least 16 weeks
  • Must have normal organ and bone marrow function, including:
    • Adequate blood hemoglobin levels (≥10.0 g/dL)
    • Normal white blood cell counts
    • Normal platelet levels
    • Normal liver function
    • Adequate kidney function
    • Must be able to swallow tablets whole without breaking or crushing them
    • For women who can become pregnant: must have a negative pregnancy test within 28 days before starting treatment
    • Must have been diagnosed with epithelial ovarian, fallopian tube or primary peritoneal cancer (except mucinous or low-grade serous types)
    • Must have confirmation of disease return at least 6 months after previous chemotherapy
    • Must have completed between 2 and 3 courses of chemotherapy
    • Must be either:
      • Never treated with PARP inhibitors before, or
      • Previously treated with PARP inhibitors without disease progression during 6 months of therapy
      • Must not have shown disease progression during or after the last platinum-based chemotherapy
      • Must agree to genetic testing for HRD (Homologous Recombination Deficiency)
      • Must start the study within 10 weeks after completing the last dose of platinum-based chemotherapy

Who cannot join the trial?

14 criteria

  • Prior history of other cancers within 5 years before starting the study (except for adequately treated non-melanoma skin cancer or carcinoma in situ)
  • Known active brain metastases (cancer that has spread to the brain)
  • Significant heart conditions including:
    • Heart attack within 6 months
    • Uncontrolled high blood pressure
    • Unstable heart rhythm problems
    • Active autoimmune diseases requiring systemic treatment (conditions where the immune system attacks healthy cells)
    • Currently receiving other cancer treatments or participating in other clinical trials
    • Known allergies to the study medications or their components
    • Pregnant or breastfeeding women
    • Serious infections requiring treatment, including active hepatitis B, hepatitis C, or HIV
    • Major surgery within 4 weeks before starting the study
    • Any condition that, in the opinion of the study doctor, would make participation unsafe
    • Unable to swallow oral medications
    • History of organ transplantation
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Investigated drugs

  • Olaparib

    is a medication used to treat certain types of cancer. It works by blocking a protein called PARP that helps repair damaged DNA in cancer cells. By preventing DNA repair, it can help stop cancer cells from growing and surviving.

  • Durvalumab

    (also known as MEDI4736) is an immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking a protein called PD-L1 that cancer cells use to hide from the immune system, allowing the body's natural defenses to better recognize and attack the cancer.

  • UV1

    is a therapeutic cancer vaccine that helps stimulate the immune system to fight cancer cells. It works by training the body's immune system to recognize and attack specific proteins found on cancer cells.

What is already known about the treatment

  • Olaparib

    An oral medication taken in tablet form that belongs to the class of PARP inhibitors, which are targeted therapy drugs. It works by blocking the PARP enzyme in cancer cells, making it harder for these cells to repair their damaged DNA, ultimately leading to their death. This medication is primarily used in the treatment of ovarian cancer, particularly in patients with specific genetic mutations, and is commonly used as a maintenance therapy to help prevent cancer recurrence after initial treatment.

  • Durvalumab

    An immunotherapy medication administered through intravenous infusion that belongs to the class of PD-L1 inhibitors. It works by helping the immune system recognize and attack cancer cells by blocking a protein called PD-L1 that cancer cells use to hide from immune cells. This medication is used in various types of cancer treatment, including ovarian cancer, and is often combined with other therapies to enhance treatment effectiveness.

  • UV1

    A therapeutic cancer vaccine administered through injection that is designed to stimulate the patient's immune system to fight cancer cells. It works by targeting specific proteins that are typically found in cancer cells, helping the immune system to recognize and attack these cells more effectively. This investigational treatment is being studied as part of combination therapy for ovarian cancer, particularly in maintenance treatment settings.

Investigated diseases

Ovarian cancer - A disease that begins in the ovaries, which are the female reproductive organs that produce eggs and hormones. It develops when abnormal cells in the ovaries start to multiply uncontrollably and form tumors. The disease can spread from the ovaries to other parts of the pelvis and abdomen over time. Early in its development, ovarian cancer may cause few noticeable symptoms. As it progresses, it may cause changes such as bloating, pelvic discomfort, and changes in bathroom habits. The disease can affect one or both ovaries and can occur at any age, though it's more common in older women.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516327-14-00Estimated enrolment188 patientsSponsorNordic Society Of Gynaecological Oncology Clinical Trial Unit

sourced from the EU Clinical Trials Register and site verification

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