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Study of Nivolumab and Ipilimumab for Patients with Advanced Liver Cancer (Hepatocellular Carcinoma) as First-Line Treatment

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 a type of liver cancer known as Hepatocellular Carcinoma (HCC). The study is investigating the effectiveness and safety of a combination of two medications, Nivolumab and Ipilimumab, compared to two other medications, Sorafenib and Lenvatinib, which are commonly used as standard treatments. The main goal is to see if the combination of Nivolumab and Ipilimumab can help patients live longer than the standard treatments.

Participants in the study will receive either the combination of Nivolumab and Ipilimumab or one of the standard treatments, Sorafenib or Lenvatinib. Nivolumab and Ipilimumab are given through an infusion, which means they are delivered directly into the bloodstream through a vein. Sorafenib and Lenvatinib are taken as oral tablets. The study will monitor participants over a period to assess the effects of these treatments on their health and the progression of their cancer.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how well the treatments are working. The study aims to provide valuable insights into the best first-line treatment options for people with advanced Hepatocellular Carcinoma who have not received prior systemic therapy. A placebo may be used in some cases to compare the effects of the active treatments.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the participant is confirmed to have advanced hepatocellular carcinoma (HCC) through histological confirmation.

    The participant must have at least one measurable lesion that has not been treated before, a Child-Pugh score of 5 or 6, and an ECOG performance status of 0 or 1.

  2. Step 2

    Randomization

    The participant is randomly assigned to one of the treatment groups. The options include a combination of nivolumab and ipilimumab, or standard care with either sorafenib or lenvatinib.

  3. Step 3

    Treatment administration

    If assigned to the nivolumab and ipilimumab group, the participant receives these medications through intravenous infusion. Nivolumab is administered as a 10 mg/mL solution, and ipilimumab as a 5 mg/mL solution.

    If assigned to the standard care group, the participant takes sorafenib orally in the form of 200 mg film-coated tablets or lenvatinib orally.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, the participant's health and response to treatment are closely monitored. This includes regular assessments to measure the size of tumors and overall health status.

    The primary goal is to compare overall survival between the treatment groups. Secondary goals include evaluating the response rate, duration of response, time to symptom deterioration, progression-free survival, and time to progression.

  5. Step 5

    Completion of study

    The study is estimated to conclude by June 30, 2025. At the end of the study, the data collected will be analyzed to determine the effectiveness and safety of the treatments.

Who can join the trial?

5 criteria

  • Participants must have a diagnosis of Hepatocellular Carcinoma (HCC), which is a type of liver cancer, confirmed by a test called histological confirmation.
  • Participants must have an advanced stage of HCC.
  • Participants must have at least one tumor that can be measured using a specific set of guidelines called Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. This tumor should not have been treated before.
  • Participants must have a Child-Pugh score of 5 or 6. This score is used to assess the liver's function and how well it is working.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to determine how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.

Who cannot join the trial?

7 criteria

  • Patients who have received prior systemic therapy for their liver cancer cannot participate. **Systemic therapy** means treatment that affects the entire body, like certain medications.
  • Patients with other serious health conditions that might interfere with the study cannot participate. This includes conditions that affect the heart, lungs, or other important organs.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and has not come back, cannot participate.
  • Patients who have an active infection that requires treatment cannot participate. This is to prevent any complications during the study.
  • Patients who have a known allergy to any of the study medications cannot participate. An **allergy** is when the body reacts negatively to a substance.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate. This is important for collecting accurate study results.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to help the body's immune system fight cancer cells. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

  • Ipilimumab

    is another medication used in combination with nivolumab in this trial. It also helps the immune system attack cancer cells by blocking a different protein that can prevent the immune system from working effectively against cancer.

  • Sorafenib

    is a standard treatment option in this trial. It is a type of medication that works by blocking certain proteins that help cancer cells grow and spread. It is used to slow down the growth of cancer cells and reduce the size of tumors.

  • Lenvatinib

    is another standard treatment option in this trial. It works similarly to sorafenib by targeting proteins that contribute to the growth and spread of cancer cells. It helps to slow down the progression of the cancer and can shrink tumors.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered intravenously and is currently being studied in combination with ipilimumab for the treatment of advanced hepatocellular carcinoma. It is an immune checkpoint inhibitor that works by blocking the PD-1 protein on T cells, enhancing the immune system's ability to attack cancer cells. Nivolumab is classified as a monoclonal antibody and is widely recognized in medical literature for its role in cancer immunotherapy.

  • Ipilimumab

    Ipilimumab is given through intravenous infusion and is being evaluated alongside nivolumab for treating advanced hepatocellular carcinoma. It functions by inhibiting the CTLA-4 protein on T cells, which boosts the immune response against cancer cells. Ipilimumab is also a monoclonal antibody and is well-documented in medical literature for its use in enhancing immune system activity in cancer treatment.

  • Sorafenib

    Sorafenib is an oral medication used as a standard treatment for advanced hepatocellular carcinoma. It works by inhibiting multiple kinases involved in tumor cell proliferation and angiogenesis, effectively slowing cancer growth. Sorafenib is classified as a kinase inhibitor and is well-established in medical literature as a treatment option for certain types of cancer.

  • Lenvatinib

    Lenvatinib is taken orally and serves as a standard treatment for advanced hepatocellular carcinoma. It acts by blocking specific proteins that promote tumor growth and blood vessel formation, thereby inhibiting cancer progression. Lenvatinib is a kinase inhibitor and is recognized in medical literature for its effectiveness in treating various cancers.

Investigated diseases

Hepatocellular Carcinoma – This is the most common type of primary liver cancer, originating in the liver cells known as hepatocytes. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As it advances, it may cause symptoms like abdominal pain, weight loss, and jaundice. The progression can vary, with some tumors growing slowly while others may spread rapidly. It is often diagnosed at an advanced stage due to the lack of early symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508635-31-00Protocol codeCA209-9DWEstimated enrolment760 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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