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Study on the Safety and Effects of Durvalumab, Tremelimumab, and Bevacizumab in Patients with Advanced Liver Cancer

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What is this study about?

This clinical trial is focused on studying treatments for advanced liver cancer, specifically a type called Hepatocellular Carcinoma. The study will explore the safety and effects of different medications, including Durvalumab (also known as MEDI4736), Tremelimumab (also known as MEDI1123), and Bevacizumab. These medications are given as solutions through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to assess how safe and tolerable these treatments are when used alone or in combination. Participants will receive either one of the medications by itself or a combination of Durvalumab with either Tremelimumab or Bevacizumab. Some participants may receive a placebo, which is a substance with no active medication. The study will monitor participants over a period to observe any side effects and how the cancer responds to the treatment.

Throughout the study, participants will undergo regular health checks, including blood tests and imaging scans like MRI or CT scans, to track their health and the progress of the cancer. The study aims to gather information on how these treatments can help manage advanced liver cancer and improve patient outcomes. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent, which means you agree to participate after understanding the study’s purpose and procedures.

2 screening tests

You will undergo various screening tests to ensure you meet the study’s eligibility criteria. These tests may include blood tests, imaging scans like CT or MRI, and a review of your medical history.

3 treatment assignment

Once eligibility is confirmed, you will be assigned to a treatment group. The study involves different treatments: durvalumab and tremelimumab as monotherapy, or durvalumab combined with tremelimumab or bevacizumab.

4 treatment administration

You will receive the assigned treatment through an intravenous infusion. The frequency and duration of the treatment will depend on the specific group you are in. The study team will provide detailed instructions on the schedule.

5 regular monitoring

Throughout the trial, you will have regular visits for monitoring. This includes checking your health status, conducting blood tests, and possibly imaging scans to assess the treatment’s effects.

6 reporting side effects

You will be asked to report any side effects or changes in your health to the study team. This information is crucial for assessing the safety and tolerability of the treatments.

7 end of treatment

After completing the treatment phase, you will have a final visit to evaluate your overall health and the study’s impact. The study team will discuss the next steps and any follow-up care needed.

Who Can Join the Study?

  • Must be a male or female aged 18 years or older (20 years or older in Japan).
  • Must agree to provide a sample of tumor tissue for research purposes.
  • Must have adequate organ and bone marrow function. This means:
    • Hemoglobin level of at least 9 g/dL.
    • White blood cell count (absolute neutrophil count) of at least 1,000/µL.
    • Platelet count of at least 75,000/µL.
    • Total bilirubin (a liver function test) no more than 2 times the normal limit.
    • AST and ALT (liver enzymes) no more than 5 times the normal limit.
    • Albumin (a protein in the blood) level of at least 2.8 g/dL.
    • International Normalized Ratio (a blood clotting test) of 1.6 or less.
    • Creatinine clearance (a kidney function test) of at least 50 mL/minute.
  • Females who can have children must use a highly effective method of birth control during the study and for a period after the last dose of the study drug. This also applies to their male partners.
  • Non-sterilized males must use a highly effective method of birth control if they have a female partner who can have children, during the study and for a period after the last dose of the study drug.
  • Must weigh more than 30 kg (about 66 pounds).
  • Must have a life expectancy of at least 12 weeks.
  • Must provide written informed consent to participate in the study.
  • Must have a confirmed diagnosis of Hepatocellular Carcinoma (HCC), which is a type of liver cancer.
  • Must not have received certain prior treatments for HCC, or must have stopped responding to or refused such treatments.
  • Must have a Child-Pugh Score of class A, which is a measure of liver function.
  • Must have an ECOG performance status of 0 or 1, which indicates the level of daily functioning.
  • If infected with Hepatitis B, must be on antiviral therapy to control the infection.
  • If infected with Hepatitis C, must have a confirmed diagnosis.
  • Must have at least one measurable tumor that has not been treated with radiation.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Hepatocellular Carcinoma (a type of liver cancer).
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications.
  • Patients who have had a recent major surgery.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan 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
15.09.2015

Trial locations

Investigated drugs:

Durvalumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is being tested to see how safe and effective it is for people with advanced liver cancer when used alone or in combination with other treatments.

Tremelimumab is another immunotherapy medication. It helps your immune system fight cancer by targeting specific proteins that can slow down your immune response. This trial is exploring how well it works on its own and when combined with other treatments for advanced liver cancer.

Bevacizumab is a medication that works by blocking the growth of new blood vessels that tumors need to grow. By cutting off the blood supply, it can help slow down or stop the growth of cancer. In this study, it is being used in combination with other treatments to see if it can improve outcomes for people with advanced liver cancer.

Investigated diseases:

Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, particularly in individuals with cirrhosis due to hepatitis B or C infection, or alcohol abuse. The disease typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As the tumor enlarges, it may cause symptoms such as abdominal pain, weight loss, and jaundice. Over time, the cancer can invade blood vessels and metastasize to other organs, complicating the condition. The progression of hepatocellular carcinoma can vary, with some tumors growing slowly and others advancing rapidly.

Trial ID:
2024-517085-41-00
Protocol code:
D4190C00022
NCT ID:
NCT02519348
Trial Phase:
Therapeutic exploratory (Phase II)

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