RecruitingPHASE3INTERVENTIONAL

Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma

This study is for people with advanced liver cancer (hepatocellular carcinoma) that can't be removed by surgery or treated with other local methods. Researchers are looking into whether new combinations of medicines, including rilvegostomig, bevacizumab, and tremelimumab, are better and safer than a common treatment combination of atezolizumab and bevacizumab. It's a large study, comparing different approaches to help improve treatment options for this type of cancer. The aim is to find out if these new drug combinations can offer a better way to fight the disease.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,220

Start

06 May 2025

Estimated completion

15 Mar 2030

Hepatocellular Carcinoma

What is this study about?

This study is a clinical trial focusing on advanced liver cancer, known medically as hepatocellular carcinoma (HCC). This type of cancer can be challenging to treat, especially when it has spread or can't be removed with surgery or other direct treatments like radiation. The main goal of this research is to explore new ways to tackle advanced HCC using different combinations of medicines.

The study will compare two main approaches. One approach involves a new drug called rilvegostomig combined with bevacizumab, and in some cases, tremelimumab. This will be measured against a widely used treatment combination for advanced HCC, which includes atezolizumab and bevacizumab. By comparing these different drug mixes, doctors hope to find out which is more effective at treating the cancer and which has fewer side effects. This could lead to better treatment options for patients in the future.

Before the main part of the study begins, there will be a small initial phase. This 'safety lead-in' period will allow researchers to carefully check the safety of one of the new drug combinations (rilvegostomig with bevacizumab and tremelimumab) in a few participants. This helps to make sure the treatment is well-tolerated before a larger group of people takes part in the main study.

Key takeaways

This study explores new drug combinations for advanced liver cancer.
It compares experimental treatments against a standard therapy.
The goal is to find more effective and safer treatment options.
Participants will receive study medications and have regular health checks.
It's for people with liver cancer that can't be treated with surgery or local methods.
Careful monitoring of safety and effects is a key part of the study.

Who may be eligible?

This study is looking for adults aged 18 or older who have advanced liver cancer (hepatocellular carcinoma) that cannot be cured by surgery or other local treatments. Your overall health should be good, meaning you can carry out most daily activities without too much difficulty. Your liver function, as measured by a Child-Pugh Score Class A, also needs to be generally good, and doctors need to be able to measure at least one cancerous area.

There are also some specific health checks. If you have hepatitis B, it needs to be stable with ongoing treatment. If you have hepatitis C, it must be well under control. You cannot have both active hepatitis B and C at the same time. You also need to have healthy organ and bone marrow function. You shouldn't have received any previous widespread drug treatments for intermediate or advanced liver cancer.

Certain health conditions would unfortunately mean you couldn't take part. This includes other current or recent cancers, poorly controlled existing health problems, autoimmune conditions needing ongoing strong treatments, or significant fluid build-up (like around the lungs or tummy) needing medical drained within the last six months. Recent use of certain blood-thinning medications or a history of severe liver-related brain issues (hepatic encephalopathy) would also exclude you. The study team will review all your medical information carefully to determine if this study is right for you.

Quick self-check

Are you 18 years or older?
Do you have advanced liver cancer that can't be operated on or treated locally?
Is your general health good enough to carry out most daily activities?
Do you have stable liver function (Child-Pugh Class A)?
Have you NOT received any widespread drug treatment for your advanced liver cancer before?
Do you NOT have other active cancers or severe, uncontrolled medical conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of several treatment groups. Each group will receive a specific combination of the study medications. These medicines are usually given through a drip (intravenous infusion) at regular intervals. You would need to attend planned visits to the study clinic for these treatments and for various assessments.

These assessments typically include physical examinations, blood tests, urine tests, and scans (like CT or MRI) to monitor your health and how the treatment is affecting your cancer. The schedule for these visits and tests will be explained in detail by the study team. You'll also be asked about any side effects you experience. The total duration of your participation in the study will depend on how you respond to the treatment and will include planned follow-up appointments after your treatment period ends to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as access to new and innovative treatments for advanced liver cancer that aren't yet widely available. However, there's no guarantee the new treatments will be effective, and they might not work for everyone. There are also potential risks involved, as all medications can have side effects. These side effects can vary from mild to severe, and the study team will monitor you closely and explain all known and potential risks before you decide to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (217)

Research Site
Phoenix, United States· Recruiting
Research Site
Tucson, United States· Not yet recruiting
Research Site
Palo Alto, United States· Recruiting
Research Site
Santa Monica, United States· Not yet recruiting
Research Site
New Haven, United States· Recruiting
Research Site
Newark, United States· Not yet recruiting
Research Site
Jacksonville, United States· Recruiting
Research Site
Atlanta, United States· Not yet recruiting
Research Site
Atlanta, United States· Withdrawn
Research Site
Chicago, United States· Not yet recruiting
Research Site
Indianapolis, United States· Not yet recruiting
Research Site
Shreveport, United States· Not yet recruiting

+205 more sites — see the official record for the full list.

Common questions

What is hepatocellular carcinoma (HCC)?

HCC is the most common type of primary liver cancer, meaning it starts in the liver. It often develops in people who have chronic liver disease.

What does 'first-line treatment' mean?

First-line treatment refers to the first therapy you receive for a condition, especially when it's newly diagnosed or when initial local treatments haven't been suitable.

Are the medications safe?

The safety of the medications is carefully monitored throughout the study. While all medicines have potential side effects, the research team will explain these and look after your well-being closely.

What does 'Phase III' mean in a clinical trial?

Phase III means the treatment has already shown promise in earlier studies and is now being tested in a larger group of people to confirm its effectiveness, compare it to existing treatments, and continue monitoring its safety.

Will I know which treatment I'm receiving?

This is an 'open-label' study in some parts, meaning you might know which treatment you're getting. However, it's also 'sponsor-blinded,' which means the drug company funding the study won't know which group you are in, to keep the results fair.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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