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A study of pumitamig and ipilimumab in patients with advanced or unresectable liver cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate different treatment options for individuals with Hepatocellular Carcinoma, which is a type of primary liver cancer that is either advanced or cannot be removed by surgery. The research compares the use of pumitamig, also known as BNT327, either by itself or used together with ipilimumab. These medications are compared against a combination of atezolizumab and bevacizumab.

The purpose of the study is to determine the safety and the most effective dosage of these treatments, and to see which combination best shrinks the tumor. Participants will receive their assigned medication through an intravenous infusion, which is a method of delivering medicine directly into a vein. During the study, researchers will monitor how the body reacts to the drugs and how much of the substances remain in the blood.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Phase 1: safety and dose determination

    Participation in this phase focuses on determining the safety of the medicines and finding the most effective dose.

    Treatment involves receiving pumitamig, which is administered through an intravenous infusion (a liquid medicine delivered directly into a vein), either alone or in combination with ipilimumab, which is also given via intravenous administration.

    Blood samples are taken to measure the levels of pumitamig and ipilimumab in the body before the next dose is given.

  2. Step 2

    Phase 2: treatment effectiveness

    This phase evaluates which treatment approach is most effective at shrinking liver cancer (hepatocellular carcinoma).

    One group receives pumitamig alone, while another group receives pumitamig combined with ipilimumab through intravenous infusion.

    A comparison group receives atezolizumab and bevacizumab, both delivered via intravenous infusion.

    The effectiveness is measured by checking if the liver cancer becomes much smaller or disappears completely.

Who can join the trial?

7 criteria

  • You must be 18 years of age or older at the time of signing the consent form.
  • You must have advanced hepatocellular carcinoma, which is a type of liver cancer that has spread or grown significantly.
  • The cancer must be unresectable, meaning it cannot be removed from the body through surgery.
  • You must be able to perform most daily activities on your own.
  • Your liver function must be good, meaning your liver is healthy enough to perform its normal tasks.
  • You must not have received certain previous treatments for your liver cancer.
  • A tumor, which is an abnormal growth of cells, must be visible on a medical scan.

Who cannot join the trial?

7 criteria

  • People who have rare types of liver cancer, which means types of liver cancer that are not commonly seen.
  • People who have serious bleeding problems or are at a high risk of bleeding easily.
  • People who have received an organ transplant, which is a surgery where a healthy organ from one person is placed into another person.
  • People with immune system diseases, which are conditions where the body's natural defense system is not working correctly.
  • People with high blood pressure that cannot be managed or kept at a healthy level even when using medication.
  • People who have too much protein in their urine, which can be a sign of kidney problems.
  • People who are currently taking strong blood-thinning medicines, which are drugs used to prevent blood clots from forming.
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Investigated drugs

  • Pumitamig

    is an experimental medicine being studied to see if it can help shrink liver cancer cells.

  • Ipilimumab

    is a type of immunotherapy that helps the body's own immune system recognize and attack cancer cells.

  • Atezolizumab

    is an immunotherapy drug used as a comparison treatment to help the immune system fight the cancer.

  • Bevacizumab

    is a medication used as a comparison treatment that works by blocking certain signals that help tumors grow new blood vessels.

What is already known about the treatment

  • Bevacizumab

    This medication is an established cancer treatment administered through an intravenous infusion into the bloodstream. It is primarily used to treat various types of tumors by working as a targeted therapy that blocks a specific protein responsible for helping tumors grow new blood vessels. By cutting off this blood supply, the drug helps to slow down or stop the growth of the cancer.

  • Atezolizumab

    This is an approved immunotherapy drug that is given to patients via an intravenous infusion. It is commonly used to treat several types of cancer by helping the body's own immune system recognize and attack cancer cells. It works at a molecular level by blocking a specific protein on immune cells that cancer cells often use to hide from the body's natural defenses.

  • Pumitamig

    This substance is currently being studied in clinical trials and is administered as a concentrated solution through an intravenous infusion. It is being investigated for its potential to treat advanced liver cancer by specifically targeting and interfering with certain biological pathways used by cancer cells. As an experimental therapy, its exact classification and full medical use are still being determined through ongoing research.

  • Ipilimumab

    This is a known immunotherapy medication that is administered to patients through an intravenous infusion. It is used to treat certain types of advanced cancers by acting on the immune system to boost its ability to fight disease. At the molecular level, it works by removing the "brakes" on immune cells, allowing them to more effectively identify and destroy cancer cells.

Investigated diseases

Hepatocellular Carcinoma - This is a type of cancer that forms in the main cells of the liver. It typically develops when liver cells undergo abnormal changes and begin to grow uncontrollably. The disease can progress as the cancerous cells multiply and form tumors within the liver tissue. Over time, these tumors may increase in size or spread to other parts of the liver or the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523602-33-00Protocol codeCA2660006Estimated enrolment129 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).