5G-EMERALD: Amivantamab in Malignant Brain Tumours
The 5G-EMERALD study is a clinical trial investigating a medication called amivantamab for aggressive brain tumours like glioblastoma. Researchers want to understand if this drug is safe to use and if it can help slow down or shrink the tumours. They are particularly interested in patients whose tumours have a specific genetic change called EGFR amplification. Initially, the study will involve 12 patients in this specific group. The drug will be given into a vein, weekly at first, then every two weeks. This first phase helps doctors decide the best dose to use in future studies. The goal is to find new ways to treat these challenging cancers.
At a glance
What is this study about?
This study, named 5G-EMERALD, is looking at a new treatment called amivantamab for people who have certain types of aggressive brain tumours, such as glioblastoma. These are serious types of cancer, and doctors are always searching for better ways to treat them. The main purpose of this study is to find out if amivantamab is safe to use and what effects it has on the tumours. This is an early-stage study, meaning it's one of the first times this drug is being tested in humans for this particular condition.
In this initial phase, doctors are focusing on a specific group of patients whose tumours have a particular genetic feature called "EGFR amplification." This means their cancer cells have extra copies of a gene that can help the tumour grow. Researchers want to see if amivantamab works especially well for these patients. By understanding the safety and early effects of the drug, they can decide if it's a promising treatment that should be studied further in more people.
The study is part of a larger research effort called Minderoo 5G, which is designed to quickly test new treatments based on the genetic makeup of a person's tumour. This personalised approach aims to find the most effective treatments for each individual. If amivantamab shows good results in terms of safety and potential anti-tumour activity, it could become an important new option for patients with these challenging brain tumours in the future.
Key takeaways
- Tests a new drug, amivantamab, for aggressive brain tumours.
- Focuses on tumours with a specific genetic feature (EGFR amplification).
- Aims to check the drug's safety and effectiveness.
- Treatment is given into a vein, weekly then every two weeks.
- Early-stage study, helping to find new treatments for the future.
Who may be eligible?
To join this study, you would need to have certain types of aggressive brain tumours, specifically a Grade 4 glioblastoma or a similar high-grade astrocytoma, as confirmed by a doctor. Your tumour should also have specific genetic features, like EGFR amplification. The study is mainly for people whose cancer has unfortunately come back after initial treatments.
You would need to be at least 16 years old and generally well enough to take part, meaning you have a good level of physical activity and no rapidly worsening nerve problems. It’s also important that your blood test results are within a healthy range. You'll need to have agreed to share your tumour's genetic information as part of a wider research programme.
There are also some requirements about your previous treatments, for example, if you've already had surgery, chemotherapy, and radiotherapy. The doctors want to make sure you're in a stable condition and that your brain tumour can be measured.
- Do I have a glioblastoma or similar high-grade brain tumour?
- Has my tumour been tested for specific genetic changes like EGFR amplification?
- Is my cancer being treated after it has come back?
- Am I at least 16 years old?
- Am I generally well and able to get around?
- Are my recent blood test results within healthy ranges?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join the study, you will receive the study drug, amivantamab, through a drip into your vein. For the first four weeks, you'll have this treatment once a week. After that, it will be given every two weeks. You'll continue with the treatment until your doctors see that your tumour is growing again or if you experience side effects that are too difficult to manage.
The very first dose of the drug is given over two separate days. The first day will be a shorter drip, and the second day will be a longer one. After that, the regular treatments will usually last for 2-5 hours. You will have regular check-ups, scans, and blood tests to monitor your health, how you are responding to the treatment, and to check for any side effects. The total duration of your participation will depend on how you respond to the treatment.
Potential risks and benefits
Locations (2)
- Cambridge University HospitalsCambridge, United Kingdom· Recruiting
- The Royal Marsden Hospital - Drug Development UnitSutton, United Kingdom· Recruiting
Common questions
What is amivantamab?
Amivantamab is a new drug being tested to see if it can target and fight certain types of cancer cells.
What kind of brain tumours is this study for?
This study is for advanced, aggressive brain tumours like glioblastoma, particularly those with a specific genetic change called EGFR amplification.
Will I know if the drug is working?
Your doctors will regularly check your tumour with scans and tests. They will discuss the results with you.
How often will I need to visit the hospital?
Initially, you'll visit weekly for your treatment, then every two weeks. You'll also have regular check-ups and tests.
Is this drug approved for use outside of a trial?
No, amivantamab is an investigational drug, meaning it's still being studied and is not yet approved for general use.
How to find out more
5G Team
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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