All studies
RecruitingPHASE2, PHASE3INTERVENTIONAL

A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC)

This study is for adults with advanced liver cancer that can't be removed with surgery. It's investigating new drug combinations to see how safe and effective they are. The main new combination is livmoniplimab and budigalimab. The study has two stages. In the first stage, different doses of the new drugs are tested alongside current treatments. The second stage then compares the best dose of the new combination with an established treatment. We want to find out if these new treatments can help control the cancer, what side effects they have, and which doses work best. About 660 people worldwide will take part, and the study is expected to last around 56 months.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
AbbVie
Enrolment target
660
Start
11 Jan 2024
Estimated completion
01 Sep 2030

What is this study about?

This study is focused on a type of liver cancer called hepatocellular carcinoma, or HCC. This is a common cancer worldwide and unfortunately, many people are diagnosed when the cancer is already advanced or has spread.

The main goal of this research is to test a new combination of treatments: livmoniplimab and budigalimab. Both of these are investigational drugs, meaning they are still being studied and are not yet widely available. The study aims to find the safest and most effective dose of this combination and compare it to existing treatments for HCC. This will help doctors understand if these new drugs could be a good option for people living with this type of cancer.

The study is divided into two main parts. In the first part, different doses of the livmoniplimab and budigalimab combination will be compared with two common treatment approaches. Based on these results, the best dose of the new combination will be chosen for the second part of the study. In this second part, that chosen dose of livmoniplimab and budigalimab will be directly compared against one of the standard treatments. Researchers hope to learn a lot about how well these new drugs work and what their side effects might be.

Key takeaways

  • This study is for adults with advanced liver cancer (HCC).
  • It's testing new drug combinations against existing treatments.
  • Drugs are given as an IV infusion (drip) at the hospital.
  • Participation involves regular hospital visits, tests, and scans.
  • The study aims to find safe, effective doses and compare them to current care.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults who have advanced liver cancer (hepatocellular carcinoma) that either can't be removed with surgery or has spread to other parts of the body. Your doctor will need to confirm your diagnosis, usually through special tests.

To be suitable, your liver cancer should be at a specific stage (BCLC Stage B or C), and your liver function also needs to be within a certain range (Child-Pugh A or B7). You should also generally be well enough to take part in a study, meaning you can mostly look after yourself and do light activities (according to a score called ECOG Performance Status of 0 or 1).

You wouldn't be able to join if you've already had other treatments for your liver cancer, have brain tumours that are causing symptoms or growing, or have had another type of cancer in the past (unless it was treated a long time ago and is not expected to return).

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.

  1. Are you an adult with liver cancer (HCC) that has spread or can't be removed by surgery?
  2. Has your doctor confirmed your diagnosis?
  3. Is your liver function stable enough (Child-Pugh A or B7)?
  4. Have you NOT had previous drug treatments for your liver cancer?
  5. Are you generally well enough to do most daily activities?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given one of the drug combinations being tested. All the study drugs will be given directly into your vein (intravenously) through a drip. Depending on which treatment group you're in, you’ll receive these infusions either every three weeks or every four weeks.

You will need to attend regular visits at a hospital or clinic. These appointments will involve various medical checks, including blood tests, answering questionnaires about your health, and having scans to see how the treatment is affecting your cancer. You’ll continue with the treatment until your cancer gets worse or if you need to stop for other reasons. The study estimates that you might be involved for about 56 months in total.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, as you would have access to new treatments that aren't yet widely available and doctors will monitor your health very closely. However, there are also potential risks, as the investigational drugs may cause side effects that we don't fully understand yet, and the treatment might not work for everyone. There will be more hospital visits and tests than if you were receiving standard care. It's really important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

  • City of Hope /ID# 261468
    Verified postcode
    Duarte, United States· Recruiting
  • City of Hope at Orange County Lennar Foundation Cancer Center /ID# 261669
    Verified postcode
    Irvine, United States· Recruiting
  • UC Irvine /ID# 255673
    Verified postcode
    Orange, United States· Recruiting
  • The University of Chicago Medical Center /ID# 255674
    Verified postcode
    Chicago, United States· Recruiting
  • Alliance for Multispecialty Research LLC Kansas City Oncology /ID# 256830
    Verified postcode
    Merriam, United States· Completed
  • Norton Cancer Institute /ID# 260775
    Verified postcode
    Louisville, United States· Recruiting
  • Henry Ford Hospital /ID# 255803
    Verified postcode
    Detroit, United States· Recruiting
  • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 256041
    Verified postcode
    Saint Louis Park, United States· Recruiting
  • Washington University-School of Medicine /ID# 255720
    Verified postcode
    St Louis, United States· Recruiting
  • Texas Oncology - Abilene - Antilley Road /ID# 265820
    Verified postcode
    Abilene, United States· Recruiting
  • Texas Oncology - Dallas - Worth Street /ID# 265806
    Verified postcode
    Dallas, United States· Recruiting
  • Baylor Scott and White Research Institute /ID# 260853
    Verified postcode
    Dallas, United States· Recruiting

Common questions

What is hepatocellular carcinoma (HCC)?

It's the most common type of liver cancer that starts in the main cells of the liver.

What are 'investigational drugs'?

These are new medicines that are still being tested in clinical trials to see if they are safe and effective before they can be widely used.

How will I receive the treatments?

All the treatments in this study are given as an infusion directly into a vein (like a drip) at the hospital or clinic.

Will I know which treatment I'm getting?

Not necessarily. In clinical trials, participants are usually 'randomized' to ensure the study is fair, meaning you have an equal chance of receiving any of the study treatments being compared.

How long will I be on the study treatment?

You will continue treatment until your cancer gets worse or if there are other medical reasons to stop, or if you decide to withdraw. The study is expected to run for about 56 months in total.

How to find out more

ABBVIE CALL CENTER

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Assess the Dose, Adverse Events, and Change in Di…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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