Recruiting

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

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 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.

The research process

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

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

16 criteria

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 trial?

6 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
Verified
Essen, Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Verified
Munich, Germany

Trial locations

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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.

What is already known about the treatment

Olaparib
Olaparib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating high-grade epithelial ovarian cancer, particularly in patients who are newly diagnosed and planning to undergo surgery. The main therapeutic indication for Olaparib is ovarian cancer, and it works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair damaged DNA in cancer cells, leading to cell death. It is classified as a PARP inhibitor in pharmacology.
Durvalumab
Durvalumab is given as an intravenous infusion. It is being explored in combination with Olaparib in clinical trials for treating high-grade epithelial ovarian cancer. The primary therapeutic use of Durvalumab is in cancer treatment, and it functions by blocking the PD-L1 protein on cancer cells, which helps the immune system recognize and attack these cells. Durvalumab is classified as an immune checkpoint inhibitor.

Investigated diseases

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.