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Study of Rilvegostomig with Bevacizumab and Tremelimumab as First-line Treatment for Patients with Advanced Liver Cancer

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 study focuses on patients with advanced hepatocellular carcinoma, which is a type of liver cancer that has spread or cannot be removed by surgery. The research evaluates several medications including rilvegostomig, bevacizumab, and tremelimumab, which are drugs that work with the immune system to fight cancer cells. Another medication being studied is atezolizumab, which also helps the immune system target cancer cells.

The main purpose of this research is to determine if combining rilvegostomig with tremelimumab and bevacizumab is more effective than using atezolizumab with bevacizumab in treating advanced hepatocellular carcinoma. These medications are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

During the study, patients will be randomly assigned to different treatment groups. One group will receive rilvegostomig together with tremelimumab and bevacizumab, while another group will receive atezolizumab with bevacizumab. The study will monitor how patients respond to these treatments over time, particularly focusing on how long patients survive after starting treatment.

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

    Initial treatment assignment

    You will be randomly assigned to one of the treatment groups for advanced liver cancer (hepatocellular carcinoma)

    Your treatment will be determined by random selection - either combination therapy with rilvegostomig, tremelimumab, and bevacizumab or atezolizumab with bevacizumab

  2. Step 2

    Medical evaluation

    Your liver function will be assessed to confirm you have Child-Pugh Score class A

    Your overall physical condition will be evaluated using a standard scale (WHO/ECOG) to confirm your ability to perform daily activities

    Your organ function and blood tests will be reviewed to ensure they are at appropriate levels

  3. Step 3

    Treatment administration

    You will receive your assigned medications through intravenous infusion

    Regular imaging scans will be performed to measure how your tumor responds to treatment

    Your overall health and any side effects will be monitored throughout the treatment period

  4. Step 4

    Follow-up assessments

    Regular medical examinations will track your progress

    Imaging scans will be reviewed by independent specialists to assess how your tumor is responding to treatment

    The duration of your response to treatment will be monitored and documented

  5. Step 5

    Study completion

    The study is expected to continue until March 2030

    Your participation will help evaluate how effective these treatment combinations are for advanced liver cancer

    Your overall survival and how long the treatment keeps the cancer under control will be key measures of the treatment's effectiveness

Who can join the trial?

11 criteria

  • Must have advanced liver cancer (hepatocellular carcinoma) that has spread or cannot be surgically removed
  • Must be able to perform daily activities with minimal assistance (WHO/ECOG status of 0 or 1, where 0 means fully active and 1 means restricted in strenuous activities but able to carry out light work)
  • Must have liver cancer at BCLC stage B (intermediate stage not suitable for local treatment) or stage C (advanced stage), with good liver function (Child-Pugh class A)
  • Must have at least one tumor that can be measured on scans
  • Must not have both hepatitis B and hepatitis C infections
  • Must have adequate liver, kidney, and blood test results during the screening period
  • Must not have received any previous systemic treatment (medication that travels through the bloodstream) for intermediate or advanced liver cancer
  • Must not be eligible for curative surgery or local treatments. If previously received treatment, must wait:
    • At least 6 months after completing preventive therapy before having confirmed spread of cancer
    • At least 28 days after completing local treatment before baseline scan
    • Both men and women can participate
    • Must be an adult (18 years or older)

Who cannot join the trial?

14 criteria

  • Have received prior systemic therapy for advanced liver cancer (hepatocellular carcinoma)
  • Have active or untreated brain tumors or brain metastases (cancer that has spread to the brain)
  • Have active autoimmune disease requiring systemic treatment
  • Have uncontrolled high blood pressure
  • Have significant heart disease or had a heart attack within the past 6 months
  • Have active bleeding or high risk of bleeding
  • Have active hepatitis B or C infection
  • Are pregnant or breastfeeding
  • Have received organ transplant and are taking medications to prevent organ rejection
  • Have had major surgery within 28 days before starting the study
  • Are currently participating in another clinical trial
  • Have severe liver dysfunction
  • Have history of other cancers within the past 3 years, except for successfully treated skin cancer or early-stage cancer
  • Have known allergy or sensitivity to any of the study medications
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Investigated drugs

  • Rilvegostomig

    is an investigational medication being studied for the treatment of advanced liver cancer (hepatocellular carcinoma). It belongs to a class of drugs that help the immune system fight cancer cells.

  • Bevacizumab

    is a medication that works by blocking the growth of blood vessels that feed tumors. It helps prevent the tumor from growing and spreading by cutting off its blood supply.

  • Tremelimumab

    is an immunotherapy medication that helps activate the body's immune system to fight cancer cells. It works by blocking signals that prevent immune cells from attacking cancer.

  • Atezolizumab

    is an immunotherapy medication that helps the body's immune system detect and fight cancer cells. It works by blocking a protein that cancer cells use to hide from immune cells.

What is already known about the treatment

  • Rilvegostomig

    An investigational immunotherapy medication being studied in clinical trials for advanced hepatocellular carcinoma (liver cancer), typically administered intravenously. This drug is being evaluated in combination with bevacizumab and tremelimumab as a first-line treatment option, representing a novel approach in cancer immunotherapy. The medication works by modulating the immune system's response to cancer cells, though its exact molecular mechanism is still under investigation in clinical trials.

  • Bevacizumab

    A well-established targeted therapy medication administered through intravenous infusion that works by blocking blood vessel formation in tumors (anti-angiogenic agent). It belongs to the class of monoclonal antibodies and functions by targeting vascular endothelial growth factor (VEGF), effectively reducing blood supply to cancer cells. This medication is commonly used in various cancer treatments, including liver cancer, and has shown effectiveness when combined with immunotherapy agents.

  • Tremelimumab

    An immune checkpoint inhibitor administered through intravenous infusion that helps activate the body's immune system to fight cancer cells. It works by blocking CTLA-4, a protein that normally helps keep immune system responses in check, thereby allowing T-cells to recognize and attack cancer cells more effectively. This medication belongs to the class of monoclonal antibodies and is being studied in combination therapy for advanced liver cancer treatment.

  • Atezolizumab

    An immunotherapy medication administered intravenously that belongs to the class of PD-L1 inhibitors. It works by blocking a protein called PD-L1 on tumor cells, which helps the immune system recognize and attack cancer cells more effectively. This medication is already approved for various types of cancer and is being used as a comparison treatment in this clinical trial for advanced liver cancer when combined with bevacizumab.

Investigated diseases

Hepatocellular Carcinoma - A primary type of liver cancer that begins in the main type of liver cells (hepatocytes). The disease typically develops in people who have chronic liver diseases, such as cirrhosis. It starts as small clusters of abnormal cells in the liver that gradually grow larger. As the cancer grows, it can spread within the liver and potentially to other parts of the body. The condition affects liver function and can cause symptoms like abdominal pain, unexplained weight loss, and yellowing of the skin.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518210-81-00Protocol codeD7029C00001Estimated enrolment1 220 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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