A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination with Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma (RELATIVITY-106)
This research, called RELATIVITY-106, is a study for people with advanced liver cancer that hasn't been treated before. It's looking at special combinations of existing medicines, Nivolumab and Relatlimab, sometimes with another medicine called Bevacizumab. The study has two main parts. First, we need to make sure the doses are safe and don't cause too many unwanted side effects. Once we confirm the safety, the second part will compare how well these different medicine combinations work. We'll be checking if they can shrink the cancer tumour or stop it from spreading, both in those with widespread cancer and those where it's only in the liver. We'll also look at how long people live without their disease getting worse and carefully monitor all potential side effects.
At a glance
What is this study about?
This study, called RELATIVITY-106, is looking into new ways to treat advanced liver cancer that has either spread to other parts of the body or is very difficult to treat, and for which patients haven't had previous treatment. It's an important step to find better options for people facing this type of cancer.
The research will explore special combinations of medicines called Nivolumab and Relatlimab. Sometimes, another medicine called Bevacizumab will be added to the mix. These medicines work in different ways to help your body's immune system fight the cancer. Nivolumab and Relatlimab are designed to help your immune system recognise and attack cancer cells. Bevacizumab focuses on stopping the blood supply that cancers need to grow.
The study has two main goals. The first part is all about safety. We need to find out if these medicine combinations are safe and what the right doses are to minimise unwanted side effects. Once safety is confirmed, the second part will compare how effective these different treatment combinations are. We will be looking at how many patients see their cancer shrink or stop growing. This includes patients whose cancer has spread and those where it's still contained in the liver. We will also carefully track how long patients live without their cancer getting worse and monitor any side effects very closely.
Key takeaways
- This study tests new combinations of medicines for advanced liver cancer.
- It aims to find out if the treatments are safe and if they can shrink or stop the cancer.
- You will receive study treatments via intravenous infusion (a drip).
- Regular health checks, blood tests, and scans will monitor your progress and safety.
- Side effects are possible, and you'll be monitored closely for them.
- You can leave the study at any time without affecting your normal medical care.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. This study is open to both men and women.
Your doctor will check if your current health condition and your liver cancer specifically fit the requirements for the study. For example, the study is for advanced liver cancer that hasn't been treated yet.
It's important to remember that all research studies have specific rules about who can take part. These rules are in place to make sure the study can safely and accurately answer its research questions. Your doctor will be able to explain all the details and confirm if this study might be suitable for you.
- Are you 18 years old or older?
- Have you been diagnosed with advanced liver cancer?
- Have you *not* had any previous treatment for your advanced liver cancer?
- Are you able to attend regular clinic appointments for treatment and check-ups?
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 receive one of the study treatments. These treatments are given through a drip (intravenous infusion). The study team will explain the schedule for your infusions, which will likely involve regular visits to the clinic.
During your time in the study, you will have regular check-ups with the medical team. This will involve blood tests, scans, and other assessments to monitor your health, how the treatment is working, and to check for any potential side effects. These assessments are crucial for the researchers to understand the safety and effectiveness of the medicines.
The study will continue until your doctor decides that the treatment is no longer beneficial for you, or if you or your doctor decide to stop treatment. Even after your treatment finishes, you will have follow-up visits for a certain period, which could be up to 135 days after your last dose, to ensure your health is still monitored.
Potential risks and benefits
Locations (5)
- —Germany
- —Spain
- —France
- —Italy
- —Poland
Common questions
What is 'advanced liver cancer'?
This means your liver cancer is either widespread in your body or cannot be treated with surgery or other local treatments.
What kinds of medicines are being tested?
The study is looking at combinations of medicines called Nivolumab, Relatlimab, and sometimes Bevacizumab, which aim to help your body fight the cancer.
What is a 'side effect'?
A side effect is an unwanted reaction or problem caused by a medicine. The study will carefully monitor for all side effects.
Will I know which treatment I'm getting?
In some parts of the study, you might not know if you're getting the active medicines or a 'dummy' treatment (placebo), until the study is over. Your doctor can explain more about this if it applies to this study.
How long will I be in the study?
The length of your participation will depend on how you respond to the treatment and your health. There will also be follow-up appointments for a few months after your treatment ends.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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