Active not recruitingPHASE3INTERVENTIONAL

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152)

This study, called IMbrave152, is for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that doctors can't cure with surgery or local treatments. It’s testing a new medication called tiragolumab alongside two existing cancer drugs, atezolizumab and bevacizumab. Researchers want to see if adding tiragolumab makes the treatment more effective and safe when used as the first treatment for this type of cancer. Initially, some people received a dummy drug (placebo) instead of tiragolumab. However, there have been some changes, and depending on your treatment group, you might be advised to stop taking tiragolumab or the placebo, while possibly continuing the other active drugs. The study aims to understand how these combinations work to improve outcomes for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

687

Start

14 Sep 2023

Estimated completion

01 Sep 2026

Hepatocellular Carcinoma

What is this study about?

This study is called IMbrave152, and it's trying to find new and better ways to treat a type of liver cancer that has spread or is advanced, making it impossible to remove with surgery. This kind of cancer is called hepatocellular carcinoma, or HCC. The research is focused on whether a new medication, tiragolumab, can improve the treatment when given with two drugs that are already used for cancer, called atezolizumab and bevacizumab. Think of it like trying out a new ingredient in a recipe that already uses two good ones, to see if it makes the dish even better.

Initially, some people in the study received a combination that included tiragolumab, while others received atezolizumab and bevacizumab with a dummy drug (placebo) instead of tiragolumab. The main goal is to check how well these combinations work at treating the cancer and if they are safe for people to take as their very first treatment. Because new information can come up in any study, there have been some updates. These updates mean that if you were receiving tiragolumab, your doctors might recommend stopping it unless they believe it's still helping you a lot. If you were getting the placebo, you would be asked to stop that. However, participants might continue with the other active drugs as long as they are beneficial and not causing too many side effects.

Studying these treatments helps doctors learn more about how to fight advanced liver cancer. The information gathered from people taking part in this study will help future patients by hopefully leading to more effective and safer treatment options. It’s a way of looking for breakthroughs in cancer medicine.

Key takeaways

Tests a new drug (tiragolumab) for advanced liver cancer.
Combines new drug with two existing cancer treatments.
Aims to find better first-line treatment options.
Involves regular clinic visits, tests, and medication.
Some treatment plans within the study have changed based on new information.
Participation includes close monitoring for safety and effectiveness.

Who may be eligible?

To be considered for this study, you would need to have liver cancer that is advanced or has spread, and doctors have confirmed it either through a biopsy (taking a small sample) or based on specific medical guidelines if you have cirrhosis. This means your cancer can't be cured by surgery or other local treatments like radiation.

It's important that you haven't received any strong, body-wide treatments for your advanced liver cancer before joining this study. Your general health and energy levels, as assessed by a simple score called ECOG, should be good (0 or 1). Also, your liver function, measured by a Child-Pugh Class A score, needs to be well within normal limits.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you wouldn't be able to participate. You also can't have had certain other immune-boosting cancer treatments in the past. If you've had a new experimental treatment recently (within 28 days) or certain local liver treatments in the last 28 days, or if you're taking medications that boost or suppress your immune system, you might not be able to join. Untreated or poorly treated bleeding issues in your food pipe or stomach also mean you can't join.

Quick self-check

Do you have advanced liver cancer that cannot be surgically removed?
Have you started any body-wide treatments for your advanced liver cancer yet?
Is your general health and energy level good?
Are your liver blood tests within a good range (Child-Pugh Class A)?
Are you able to use reliable birth control if needed for several months after treatment?
Have you recently received other experimental treatments or certain immune-affecting drugs?

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

What does participation involve?

If you join this study, you will receive combinations of medications specifically designed for the trial. These include atezolizumab and bevacizumab, and you might also receive tiragolumab or a dummy drug (placebo) instead of tiragolumab. You will have regular visits to the clinic for check-ups, which include blood tests, scans (like CT or MRI) to see how the cancer is responding, and a review of any side effects you might be experiencing. These visits will be frequent at first and then less often as the treatment continues. You will continue treatment as long as it benefits you and the side effects are manageable. The overall duration of your participation will depend on how you respond to the treatment and your health, but you will be monitored throughout. There will also be follow-up appointments after you stop active treatment to see how you are doing long-term. You will need to carefully follow birth control guidelines for several months after stopping treatment if you could become pregnant or get someone pregnant.

Potential risks and benefits

Taking part in a clinical trial like this offers the potential benefit of trying new treatments that might work better than standard options for your condition, and you'll receive close medical attention. However, there are also potential risks, as the medications might cause side effects, some of which could be serious. The new drug, tiragolumab, is still being studied, so its full range of effects and how it interacts with other drugs are not completely known. You will be closely monitored for any side effects, and your safety is the top priority. It's important to remember that you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (171)

Genesis Cancer Center
Hot Springs, United States
UCSF Fresno at Community Cancer Institute
Clovis, United States
City of Hope Cancer Center
Duarte, United States
University of California San Diego Moores Cancer Center
La Jolla, United States
University of Southern California
Los Angeles, United States
Stanford Cancer Center
Palo Alto, United States
Va Palo Alto Health Care System
Palo Alto, United States
UCLA Cancer Center
Santa Monica, United States
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, United States
MedStar Washington Hosp Center
Washington D.C., United States
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers, United States
Miami VA Healthcare System
Miami, United States

+159 more sites — see the official record for the full list.

Common questions

What kind of cancer is this study for?

This study is for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that can't be removed by surgery.

What medications are being tested?

It's testing a new medication called tiragolumab, combined with two existing cancer drugs: atezolizumab and bevacizumab.

Will I definitely get the new drug?

You might get the new drug (tiragolumab), or you might get a dummy drug (placebo) along with the other two active cancer drugs. It depends on which group you are assigned to.

Why were some people asked to stop taking tiragolumab or placebo?

During a study, researchers sometimes get new information. Based on this, doctors might recommend stopping certain parts of the treatment, like tiragolumab or the placebo, unless they believe it's providing a clear benefit.

How long will I be in the study?

You will stay in the study as long as the treatment is helping you and you can manage any side effects. You'll also have follow-up appointments after stopping treatment.