RecruitingPHASE2INTERVENTIONAL

Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure

This clinical trial is for people with advanced liver cancer that has spread or can't be removed by surgery, and who have already tried a first treatment that didn't work. The study wants to find out if a new drug called visugromab, when given alongside two existing cancer drugs, nivolumab and lenvatinib, is better and safer than just taking lenvatinib. It involves comparing these drug combinations to see which approach helps patients more. This type of research helps doctors understand the best ways to treat liver cancer, especially when initial treatments aren't successful. The study is in its second phase, meaning it's building on earlier research.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

CatalYm GmbH

Enrolment target

104

Start

19 Mar 2026

Estimated completion

01 Sep 2031

Unresectable or Metastatic Hepatocellular Carcinoma Child-Pugh A Hepatocellular Carcinoma Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound

What is this study about?

This study is a clinical trial for people living with a type of liver cancer called hepatocellular carcinoma (HCC). This is when the cancer has spread or can't be removed by surgery. It's specifically for those who have already had one round of powerful cancer treatment that included a particular type of drug (called an anti-PD-(L)1 compound) and it didn't work well enough.

The main goal of this trial is to investigate a new treatment approach. Researchers want to see if combining a new medicine, visugromab, with two other established cancer drugs, nivolumab and lenvatinib, is more effective and safer than taking lenvatinib alone. Lenvatinib is a common treatment for this type of cancer. By comparing the groups, doctors hope to find better ways to manage advanced liver cancer.

This is a 'Phase 2b' trial, which means it’s past the very early stages and is looking more closely at how well the treatment works and its side effects in a larger group of people. The participants will be divided into different groups by chance (randomized), and neither you nor your doctor will know which specific treatment you are receiving until the study is over. This helps make the results fair and unbiased.

Key takeaways

This study is for advanced liver cancer that hasn't responded to previous treatment.
It tests a new drug combination including visugromab, nivolumab, and lenvatinib.
The new combination is compared against lenvatinib alone.
Participation involves regular clinic visits, blood tests, and scans.
You won't know which treatment group you are in.
The aim is to find more effective and safer treatments for advanced liver cancer.

Who may be eligible?

To be considered for this study, you would need to have liver cancer (hepatocellular carcinoma) that has spread or can't be removed by surgery. You must have already tried one line of treatment for your advanced liver cancer that included a specific type of immunotherapy drug (an anti-PD-(L)1 drug) for at least 12 weeks, and that treatment wasn't successful.

Your liver also needs to be working well, and your general health should be good enough to take part in a clinical trial. There are also requirements about your age – you generally need to be 18 years or older, and doctors will assess that you are expected to live for at least three months. Your cancer also needs to be measurable on scans so doctors can track any changes.

There are also some reasons why you might not be able to join. For example, if you have certain types of liver cancer (like fibrolamellar HCC), have had more than one previous treatment for your advanced liver cancer, or have recent serious heart problems. Also, if you have certain other serious health conditions, particularly autoimmune diseases that need strong medication, or active infections in your gut, you might not be suitable for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have liver cancer (HCC) that has spread or can't be removed by surgery?
Have you already had one treatment for your advanced liver cancer that included an 'anti-PD-(L)1' drug, and it didn't work well enough?
Is your liver function generally good (Child-Pugh A)?
Are you 18 years old or older and in reasonably good health?
Are you able to attend regular hospital visits for check-ups and treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance (like flipping a coin, but your doctor won't know the result) to one of two treatment groups. One group will receive visugromab, nivolumab, and lenvatinib, while the other group will receive lenvatinib along with two dummy treatments (placebos) that look just like the real drugs. You and your doctor won't know which group you're in, as this helps make the study results as accurate as possible.

Taking part will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. You'll receive the study medicines as prescribed. The team will carefully explain the schedule of visits and treatments, along with any necessary follow-up care. The exact duration of your participation will depend on how you respond to the treatment and the study's protocol, but it will involve ongoing assessments as long as you are on treatment.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new combination of treatments that could be more effective than standard care, especially if your current treatment isn't working. However, as with all medical treatments, there are potential risks, including side effects from the medications. These side effects will be carefully monitored by the study team, and you'll be given detailed information about them. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität
Verified postcode
Frankfurt, Germany· Recruiting
Asst Grande Ospedale Metropolitano Niguarda
Verified postcode
Milan, Italy· Recruiting

Common questions

What is 'unresectable or metastatic HCC'?

This means liver cancer that has spread to other parts of your body, or is in a place in the liver where it can't be safely removed by surgery.

What is an 'anti-PD-(L)1 compound'?

This is a type of immunotherapy drug that helps your own immune system fight cancer cells. You would have had one of these in your previous treatment.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real drug but contains no active medicine. It helps researchers compare the real drug's effects accurately.

Will I know which treatment I am getting?

No, this is a 'blinded' study, meaning neither you nor your doctor will know whether you are receiving the new combination or the lenvatinib with placebos. This keeps the study fair.

What is 'Child-Pugh A'?

This is a way doctors measure how well your liver is working. Child-Pugh A means your liver function is generally good, which is important for participating in this study.

How to find out more

Felix Lichtenegger, MD

regulatory-005@catalym.com +49892000664 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.