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Study of Durvalumab and Tremelimumab for Patients with Advanced Liver Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of Advanced Hepatocellular Carcinoma, a type of liver cancer that cannot be removed by surgery. The study will use two medications: Durvalumab and Tremelimumab. Durvalumab is also known by its code name MEDI4736, and Tremelimumab is sometimes referred to as CP-675,206 or Ticilimumab. These medications are given as infusions, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to assess the safety and effectiveness of these medications when used together as a first-line treatment for patients with advanced liver cancer. Participants will receive a single dose of Tremelimumab and regular doses of Durvalumab every four weeks. The study will monitor participants over a period to observe any side effects and how well the treatment works in controlling the cancer.

Throughout the study, participants will undergo regular health assessments to track their response to the treatment. The study aims to provide valuable information on how these medications can be used to treat advanced liver cancer, potentially offering new options for patients with this condition. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 initial visit

Upon joining the study, you will have an initial visit with the study team. During this visit, your medical history will be reviewed, and a physical examination will be conducted to ensure you meet the study criteria.

Blood tests and imaging studies, such as CT or MRI scans, may be performed to assess your current health status and the extent of your condition.

2 treatment initiation

You will begin treatment with two medications: tremelimumab and durvalumab. Tremelimumab will be administered as a single dose of 300 mg through an intravenous infusion.

Durvalumab will be given as an intravenous infusion at a dose of 1500 mg every four weeks. This schedule is referred to as Q4W, meaning once every four weeks.

3 ongoing treatment and monitoring

You will continue to receive durvalumab infusions every four weeks. Regular visits will be scheduled to monitor your response to the treatment and to check for any side effects.

During these visits, additional blood tests and imaging studies may be conducted to evaluate the effectiveness of the treatment and to ensure your safety.

4 completion of treatment

The treatment phase will continue as long as it is deemed beneficial and safe for you, or until the study reaches its conclusion.

After the last dose of the study medication, follow-up visits will be scheduled to monitor your health and to gather information on the long-term effects of the treatment.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must weigh more than 30 kg (about 66 pounds).
  • Can be male or female.
  • If you have a hepatitis B virus (HBV) infection, you must be on antiviral medication to control the virus before joining the study and continue it during the study and for 6 months after the last dose of the study medication.
  • Must have adequate organ and bone marrow function, which means your body is working well enough to handle the study treatment. This includes having enough red blood cells, white blood cells, and platelets, and proper liver and kidney function.
  • If you have a hepatitis C virus (HCV) infection, it must be confirmed by a test showing the virus is present in your blood.
  • Must have unresectable hepatocellular carcinoma (HCC), which means liver cancer that cannot be removed by surgery, confirmed by medical tests.
  • Must not have received any previous treatment that affects the whole body for HCC.
  • Must be expected to live for at least 12 weeks.
  • Must have at least one tumor that can be measured accurately with a CT or MRI scan.
  • Must not be eligible for local regional therapy (LRT) for HCC, which is a treatment that targets the liver directly.
  • Must have a specific stage of liver cancer, known as BCLC stage B or C.
  • Must have a Child-Pugh score and WHO/ECOG performance status that fits certain criteria, which are measures of liver function and general health.
  • Male participants must use effective birth control if they are sexually active with a woman who can become pregnant, and must not donate sperm during the study and for a period after.
  • Female participants must have a negative pregnancy test and use effective birth control if they can become pregnant.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and has not returned.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
  • Patients who have received certain medications or treatments that might interfere with the study drugs.
  • Patients with a history of severe allergic reactions to similar drugs.
  • Patients who have a condition that affects their immune system, making it weaker.
  • Patients who have had a major surgery recently.
  • Patients who are participating in another clinical trial.
  • Patients who have a history of substance abuse that could affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Hôpital Avicenne Bobigny France
Hospital Universitario Reina Sofía Cordoba Spain
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Universita’ Di Pisa Pisa Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Deutsches Herzzentrum Berlin Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Heidelberg University Mannheim Germany
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Azienda Sanitaria Locale Napoli 1 Centro Naples Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Ufbituobip Hcqlnutb Cdbdehf Cologne Germany
Apkplumbho Ptvqtgha Htzxeypb Dk Mmexwufie Marseille France
Hsafxruv Vuty dswesjwz Barcelona Spain

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
07.07.2023
Germany Germany
Not recruiting
07.07.2023
Italy Italy
Not recruiting
07.07.2023
Spain Spain
Not recruiting
07.07.2023

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 used to treat advanced liver cancer, specifically in patients who cannot have surgery to remove the cancer. The goal is to see if it can help slow down the growth of the cancer or even shrink it.

Tremelimumab is another immunotherapy medication. It also helps your immune system fight cancer by targeting specific proteins that can stop the immune system from working properly. In this study, it is used alongside Durvalumab to see if the combination can be more effective in treating advanced liver cancer than using either treatment alone. The researchers are looking to understand how safe and effective this combination is for patients with certain liver conditions.

Investigated diseases:

Advanced Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the liver cells, known as hepatocytes. In its advanced stage, the cancer has spread beyond the liver to other parts of the body, making it unresectable, meaning it cannot be removed surgically. The disease progresses as cancerous cells multiply and invade surrounding tissues, potentially affecting liver function and causing symptoms such as abdominal pain, weight loss, and jaundice. As the cancer advances, it may lead to complications like portal vein thrombosis, where a blood clot forms in the vein that carries blood from the intestines to the liver. The progression of the disease can also be influenced by underlying liver conditions, such as cirrhosis or chronic hepatitis. Advanced hepatocellular carcinoma requires careful management to address symptoms and maintain quality of life.

Trial ID:
2022-502012-37-00
Protocol code:
D419CR00030
Trial Phase:
Therapeutic confirmatory (Phase III)

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