Study on Olaparib and Durvalumab for Patients with Advanced Ovarian Cancer Undergoing Surgery

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What is this study about?

This clinical trial is focused on studying treatments for patients with advanced stage ovarian cancer. The study involves two main treatments: Olaparib, which is a type of cancer medicine known as a PARP inhibitor, and Durvalumab, a checkpoint inhibitor. These treatments are being tested to see if they can be used effectively before surgery to remove the cancer. The trial is divided into two groups: one group will receive Olaparib alone, and the other group will receive a combination of Olaparib and Durvalumab.

The purpose of the study is to explore the feasibility of using these treatments in a specific time window before surgery. Participants will receive the treatment for a period of time before undergoing surgery to remove the cancer. The study will monitor how well the treatments are tolerated and whether they can be given without causing delays in surgery. The trial will also look at the safety of the treatments and any side effects that may occur.

Participants in the study will be those who have been newly diagnosed with high-grade ovarian cancer and are planning to have surgery. The study will involve taking the medication either orally or through an infusion, depending on the treatment group. The trial aims to gather information on how these treatments can be used effectively in the early stages of cancer treatment, potentially improving outcomes for patients with ovarian cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of advanced stage ovarian cancer and the ability to take oral medication.

A negative pregnancy test is required for women of childbearing potential, and effective contraception must be used during the study and for six months after the last dose of study drugs.

2 initial assessment

An initial assessment involves a laparoscopy to confirm the diagnosis and plan treatment. Blood and tissue samples are collected for research purposes.

Normal organ and bone marrow function are verified through blood tests.

3 treatment phase

The treatment phase involves taking Lynparza (olaparib) tablets orally. The dosage is either 100 mg or 150 mg, depending on the specific treatment plan.

In some cases, IMFINZI (durvalumab) is administered intravenously in combination with Lynparza. The solution for infusion is given at a concentration of 50 mg/mL.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes scheduled visits and examinations.

The primary goal is to complete the treatment without surgical delays or significant side effects.

5 surgery preparation

After the treatment phase, preparation for primary debulking surgery is undertaken. This involves evaluating the disease status and ensuring optimal conditions for surgery.

The surgery is planned based on the results of the treatment and the overall health status.

Who Can Join the Study?

Patients must have presumed and previously untreated advanced stage ovarian cancer and be planned to undergo a procedure called laparoscopy for diagnosis and treatment planning.
Patients must be able to take medication by mouth.
Patients must be postmenopausal or have proof of not being able to have children. This includes a negative pregnancy test within 28 days before the study treatment and another negative test before starting treatment. Postmenopausal means not having a period for 1 year or more after stopping hormone treatments, having certain hormone levels, or having had certain surgeries or treatments.
Women who can have children and their partners must agree to use two highly effective forms of birth control or completely avoid sexual intercourse during the study and for at least 6 months after the last dose of the study drug.
Patients must have confirmed advanced high-grade ovarian, fallopian tube, or primary peritoneal cancer, or a known BRCA mutation, and be planned for primary debulking surgery after diagnosis confirmation.
Patients must weigh more than 30 kg (about 66 pounds).
Patients must have normal organ and bone marrow function, which includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and kidney function.
Patients must have successfully provided blood and tissue samples as required by the study.
Patients must be willing and able to follow the study protocol, including attending scheduled visits and examinations.
Patients must be able and willing to provide biopsy samples from laparoscopy and primary debulking surgery for research purposes.
Patients must be able and willing to provide tissue samples preserved in a specific way from laparoscopy and primary debulking surgery.
Patients must be at least 18 years old.
Patients must be capable of giving signed informed consent, which means they understand and agree to the study’s requirements and restrictions.
Patients must provide signed and dated written consent for both the research and clinical parts of the study before any study-specific procedures.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which is a measure of their ability to perform daily activities.
Patients must have a life expectancy of at least 16 weeks.

Who Cannot Join the Study?

Patients who have already received treatment for their ovarian cancer.
Patients who are not planned to undergo laparoscopy, which is a type of surgery where doctors use a small camera to look inside the abdomen, for diagnosis and treatment planning.
Patients who do not have high-grade ovarian cancer, which is a more aggressive form of cancer.
Patients who are not planned for primary debulking surgery, which is a surgery to remove as much of the tumor as possible.
Patients who are male, as the study is only for female patients.
Patients who are considered part of a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Mammazentrum Hamburg MVZ GbR	Hamburg	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Kurhodvv Exnmrdqycmicqqpmtwdupkxv Hnqucgbidwaayzacx	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	05.05.2022

Trial locations

Investigated drugs:

Olaparib is a medication used in this trial to treat patients with newly diagnosed high-grade ovarian cancer. It is given before surgery to see if it can help reduce the size of the cancer or slow its growth. Olaparib works by interfering with the cancer cells’ ability to repair their DNA, which may lead to the death of these cells.

Durvalumab is another medication used in combination with Olaparib in this trial. It is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. By combining Durvalumab with Olaparib, the trial aims to see if this combination is more effective in treating high-grade ovarian cancer before surgery.

Ovarian Cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are the female reproductive glands. It often goes undetected until it has spread within the pelvis and abdomen, making it more challenging to treat. The disease progresses through stages, starting from the ovaries and potentially spreading to nearby organs and tissues. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits, but they often appear only in advanced stages. The progression of ovarian cancer can vary, with some cases advancing more rapidly than others. Early detection is difficult, as initial symptoms are often vague and easily mistaken for other common conditions.

Trial ID:

2024-511780-28-00

Protocol code:

AGO-OVAR 27

NCT ID:

NCT04644289

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Olaparib and Durvalumab for Patients with Advanced Ovarian Cancer Undergoing Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?