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Study on the Effectiveness of Olaparib and Bevacizumab for Maintenance Treatment in Patients with HRD-Positive Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for patients with advanced, high-grade epithelial ovarian cancer, including cancer of the fallopian tube or primary peritoneal cancer. The study involves patients whose tumors show a specific genetic defect in a DNA repair mechanism known as homologous recombination deficiency (HRD). The treatment being tested combines two medications: olaparib, which is a type of drug known as a PARP inhibitor, and bevacizumab, a monoclonal antibody. These medications are given as maintenance therapy, which means they are used to help keep the cancer from coming back after the initial treatment.

The purpose of the study is to confirm how well this combination works in patients who have already received a standard chemotherapy treatment that includes a platinum-based drug and bevacizumab. After completing this initial treatment, patients who show a complete or partial response and have HRD-positive tumors will start taking olaparib along with bevacizumab. The study will observe how patients respond to this maintenance therapy over time.

Participants in the trial will receive the treatment over a period of time, and their health will be monitored to see how the cancer responds and to check for any side effects. The study aims to provide more information about the effectiveness and safety of using olaparib and bevacizumab together in treating this type of cancer. The trial will also gather data on the characteristics of patients who benefit from this treatment approach.

1 joining the trial

Upon joining the trial, informed consent is required. This means agreeing to participate after understanding the trial’s purpose and procedures.

Eligibility is confirmed based on specific criteria, including age, diagnosis of high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer, and other health conditions.

2 initial treatment

The initial treatment involves a combination of chemotherapy and a medication called bevacizumab. This phase is designed to address the cancer directly.

Chemotherapy is administered in cycles, and the specific schedule will be provided by the healthcare team.

3 maintenance therapy

If the initial treatment is successful, maintenance therapy begins. This involves taking olaparib in combination with bevacizumab.

Olaparib is taken orally in the form of tablets. The dosage is either 150 mg or 100 mg, as prescribed by the healthcare provider.

The frequency and duration of taking olaparib will be determined by the healthcare team based on individual response and tolerance.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

Follow-up appointments will be scheduled to evaluate progress and make any necessary adjustments to the treatment plan.

5 completion of trial

The trial is expected to continue until June 2026, but individual participation may vary based on personal health and response to treatment.

Upon completion, final assessments will be conducted to gather data on the treatment’s efficacy and safety.

Who Can Join the Study?

  • Provide informed consent, which means you agree to participate after understanding the study details.
  • You must be at least 18 years old.
  • Have a new diagnosis of high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer.
  • Have advanced disease, classified as FIGO stage III-IV. FIGO is a system used to describe the extent of cancer.
  • Provide tumor samples from your primary cancer for testing. These samples must be preserved in a specific way called formalin-fixed, paraffin-embedded (FFPE).
  • Be suitable to receive a specific type of chemotherapy called platinum-taxane chemotherapy along with a drug named bevacizumab.
  • Have normal organ and bone marrow function before starting the chemotherapy and bevacizumab treatment.
  • Have normal blood pressure or controlled high blood pressure, with systolic blood pressure ≤ 140 mmHg and/or diastolic blood pressure ≤ 90 mmHg.
  • Have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can carry out light work.
  • Have a life expectancy of at least 16 weeks.

Who Cannot Join the Study?

  • Patients who do not have a confirmed diagnosis of advanced, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Patients who are not eligible to start a chemotherapy regimen with the drug bevacizumab. Bevacizumab is a medication used to treat certain types of cancer by slowing the growth of new blood vessels that tumors need to grow.
  • Patients whose tumor samples do not show a positive result for HRD status using the Myriad Mychoice CDxPlus test. HRD status refers to a condition where the tumor has a deficiency in repairing DNA damage, which can make it more responsive to certain treatments.
  • Patients who do not achieve a complete or partial response after initial treatment with platinum-based chemotherapy plus bevacizumab. A complete response means no signs of cancer are found, while a partial response means the cancer has shrunk but is still present.
  • Patients who do not have a tumor with a BRCA1-2 mutation as determined by the Myriad Mychoice CDx Plus evaluation. BRCA1-2 mutations are changes in specific genes that can increase the risk of certain cancers.
  • Patients who do not meet other specific eligibility criteria for starting treatment with olaparib in addition to bevacizumab. Olaparib is a medication used to treat certain types of cancer by interfering with the cancer cells’ ability to repair their DNA.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy

Other Sites

Site Name City Country Status
Alessandro Manzoni Hospital Lecco Italy
Istituto Oncologico Veneto Padua Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universita Degli Studi Di Brescia Brescia Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Azienda Socio Sanitaria Territoriale Lariana Como Italy
National Cancer Institute Milan Italy
Atcevew Ufh Ijygk Dc Rrzuwv Egfora Reggio Emilia Italy
Axathrb Opojrldrbfu Ulvqbpduypqcx Cpegtqrmpncs Dbjzk Sfevbx E Dkvmp Sclmvti Dg Txcryj Turin Italy
Uojdoymtfe Dnohq Spjqc Dc Rbbg Lz Ssjcybmf Rome Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
03.04.2023

Trial locations

Investigated drugs:

Olaparib is a medication used in this trial to help treat ovarian cancer. It works by blocking a specific protein in cancer cells, which helps to stop the cancer from growing and spreading. In this study, olaparib is used as a maintenance treatment, which means it is given to help keep the cancer from coming back after the initial treatment.

Bevacizumab is another medication used in this trial alongside olaparib. It works by targeting and blocking a protein that helps cancer cells form new blood vessels. By doing this, bevacizumab helps to cut off the blood supply that the cancer needs to grow. In this study, it is used as part of the maintenance treatment to help prevent the cancer from returning after the first round of chemotherapy.

Epithelial Ovarian Cancer – Epithelial ovarian cancer is a type of cancer that begins in the layer of cells covering the ovaries. It is characterized by the abnormal growth of cells that can invade or spread to other parts of the body. The disease often progresses silently, with symptoms appearing only in advanced stages. As it advances, it may cause abdominal swelling, pain, and changes in bowel habits. The cancer can spread to the lining of the abdomen and other organs. It is often detected at a later stage due to its subtle early symptoms.

Fallopian Tube Cancer – Fallopian tube cancer is a rare type of cancer that originates in the fallopian tubes, which connect the ovaries to the uterus. It typically begins in the cells lining the inside of the tubes. The disease progresses as the cancerous cells grow and potentially spread to nearby organs and tissues. Symptoms may include pelvic pain, abnormal vaginal discharge, and a palpable mass. As the cancer advances, it can affect the surrounding reproductive organs and the abdominal cavity. Early detection is challenging due to the non-specific nature of initial symptoms.

Primary Peritoneal Cancer – Primary peritoneal cancer is a rare cancer that starts in the peritoneum, the thin layer of tissue lining the abdomen. It is similar to epithelial ovarian cancer in terms of its behavior and progression. The disease progresses as cancer cells grow and spread within the abdominal cavity. Symptoms may include abdominal pain, bloating, and changes in bowel habits. As it advances, it can affect the function of abdominal organs and lead to fluid accumulation. The cancer is often diagnosed at an advanced stage due to its subtle early symptoms.

Trial ID:
2022-502242-27-00
Protocol code:
IRFMN-OVA-8542
Trial Phase:
Therapeutic confirmatory (Phase III)

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