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Study of Olaparib and Durvalumab for Patients with Metastatic Pancreatic Cancer and DNA Repair Gene Alterations

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What is this study about?

This clinical trial is focused on studying the effects of two medications, olaparib and durvalumab (also known as MEDI4736), in patients with metastatic pancreatic cancer. Metastatic pancreatic cancer is a type of cancer that has spread from the pancreas to other parts of the body. The study aims to evaluate how well these medications work together in treating this condition, particularly in patients who have specific changes in their DNA that affect how their cells repair damage.

Participants in the study will receive a combination of olaparib and durvalumab. Olaparib is taken orally, meaning it is swallowed in pill form, while durvalumab is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The study will last for a period of up to six months, during which the effects of the treatment will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The purpose of the study is to assess the overall response rate, which refers to the percentage of patients who experience a reduction in the size of their tumors or complete disappearance of the cancer. The study will also look at other outcomes, such as the time it takes for the disease to progress and the overall survival of the participants. This research is important for understanding how these medications can be used to improve treatment for patients with metastatic pancreatic cancer and specific DNA changes.

1 initial visit

Upon joining the clinical trial, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, including age, previous treatments, and overall health status.

A series of tests and assessments are conducted to ensure normal organ and bone marrow function. A performance status score is evaluated to determine the ability to perform daily activities.

2 consent and preparation

Written informed consent is obtained, confirming understanding and agreement to comply with the trial requirements.

For women of childbearing potential, a pregnancy test is conducted. Male participants are advised on contraceptive measures during and after the trial.

3 treatment initiation

The treatment phase begins with the administration of two medications: durvalumab and olaparib.

Durvalumab is given through an intravenous infusion, which involves receiving the medication directly into the bloodstream through a vein.

Olaparib is taken orally in the form of tablets. The dosage and frequency are determined by the medical team based on individual needs.

4 ongoing treatment and monitoring

Regular visits are scheduled to monitor the response to treatment and manage any side effects. These visits include physical examinations, blood tests, and imaging studies.

The overall response rate is assessed to determine the effectiveness of the treatment. Adjustments to the treatment plan may be made based on these assessments.

5 end of treatment

The treatment phase continues until the study’s end date or until it is determined that the treatment is no longer beneficial.

A final assessment is conducted to evaluate the overall health status and response to the treatment.

Who Can Join the Study?

  • Must be a male or female aged 18 years or older.
  • Must have received platinum-based chemotherapy and benefited from it without the disease getting worse during treatment. Benefit means the disease got smaller or stayed the same for at least 6 months.
  • Must have normal organ and bone marrow function, which will be checked within 28 days before starting the study treatment.
  • Must weigh more than 30 kg (about 66 pounds).
  • Must have a Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well you can perform daily activities.
  • Must have a measurable disease as defined by specific guidelines (RECIST version 1.1).
  • Must have a life expectancy of at least 16 weeks.
  • Women who can have children must show they are not pregnant with a negative pregnancy test within 7 days before starting the study treatment.
  • Male patients must use a condom during treatment and for 3 months after the last dose when having sexual intercourse with a pregnant woman or a woman who can have children. Female partners should also use a highly effective form of birth control if they can have children. Male patients should not donate sperm during treatment and for 3 months after the last dose.
  • Must have recovered from any side effects of previous treatments to a mild level, except for hair loss.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other trial procedures.
  • Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.
  • Must have a confirmed diagnosis of metastatic adenocarcinoma of the pancreas, which means the cancer has spread from the pancreas to other parts of the body.
  • Must have changes in DNA damage repair (DDR) genes in the tumor tissue or blood, which will be tested by a laboratory.
  • Must have received at least one line of chemotherapy for metastatic disease and no more than two lines. If the disease came back within 6 months after completing previous treatment, it counts as the first line of chemotherapy.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than metastatic pancreatic cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to provide informed consent cannot participate.
  • Patients who have any other serious medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had another cancer treatment recently that might interfere with the study cannot participate.
  • Patients who have allergies to the study medications cannot participate.
  • Patients who are participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital General Universitario De Valencia Valencia Spain
Hkwpgjsp Ufycvosjgnvgn Mmlnnwd Dq Voclasvhnw Santander Spain
Isioaokn Cmfnaf Dqcokrnngmzvgnbgy L'hospitalet De Llobregat Spain
Hbrzuxgp Vmcw dbduqskm Barcelona Spain
Hmusyskz Unuklazzjhdza dq A Csvblq A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
01.12.2022

Trial locations

Investigated drugs:

Olaparib is a medication used in this clinical trial to help treat patients with metastatic pancreatic cancer. It works by targeting cancer cells that have specific genetic changes, particularly in DNA Damage Repair genes. By interfering with the cancer cells’ ability to repair their DNA, olaparib can help slow down or stop the growth of the cancer.

Durvalumab, also known by its code name MEDI4736, is another medication used in this trial. It is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. Durvalumab works by blocking a specific protein that cancer cells use to hide from the immune system, allowing the immune system to better detect and destroy the cancer cells.

Metastatic pancreatic cancer – This disease occurs when cancer that originated in the pancreas spreads to other parts of the body. It typically progresses through the lymphatic system or bloodstream, reaching organs such as the liver, lungs, or peritoneum. As the cancer spreads, it can cause symptoms like abdominal pain, weight loss, and jaundice. The progression often involves the formation of new tumors in the affected organs, which can disrupt their normal function. Over time, the disease can lead to increased complications as more organs become involved. The spread of cancer cells can also lead to the development of secondary tumors, further complicating the condition.

Trial ID:
2024-510970-26-00
Protocol code:
TTD-20-04
NCT ID:
NCT05659914
Trial Phase:
Therapeutic exploratory (Phase II)

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