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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Oslo Universitetssykehus HF Oslo Norway
Medical University Of Vienna Vienna Austria
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Helse Stavanger HF Stavanger Norway
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
National Cancer Centre of Santaros klinikos Vilnius Lithuania
Sørlandet sykehus Kristiansand Kristiansand Norway
Region Skane Skanes Universitetssjukhus Lund Sweden
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Karolinska University Hospital Solna Sweden
Stichting Radboud University Medical Center Nijmegen The Netherlands
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Turku University Hospital Turku Finland
Aalborg University Hospital Aalborg Denmark
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Kuopio University Hospital Kuopio Finland
Lkh Fbdhxcwxm Feldkirch Austria
Oirxil Upuiuacqdelchfileojs Odense Denmark
Hgqsz Bucffj Hy Bergen Norway
Erpzhww Uydpauvjqpvh Mopjjeu Cggpyab Ryfumcjul (qrrdanc Mou Rotterdam The Netherlands
Kjkouabm Eyvalnwrcuqtcabyntojnqoy Hdiawfjkkablueweb Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
13.12.2021
Belgium Belgium
Not recruiting
13.12.2021
Denmark Denmark
Not recruiting
13.12.2021
Finland Finland
Not recruiting
13.12.2021
Germany Germany
Not recruiting
13.12.2021
Lithuania Lithuania
Not recruiting
13.12.2021
Norway Norway
Not recruiting
13.12.2021
Sweden Sweden
Not recruiting
13.12.2021
The Netherlands The Netherlands
Not recruiting
13.12.2021

Trial locations

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.

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 ID:
2024-516327-14-00
NCT ID:
NCT04742075
Trial Phase:
Therapeutic exploratory (Phase II)

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