Tessa Jowell BRAIN-MATRIX

The Tessa Jowell BRAIN-MATRIX is a first-of-its-kind clinical trial that will enable doctors to treat brain tumours with drugs that are more targeted than ever before. We are excited to be investing £2.8 million to set the trial up, and to drive it into the future.

Although the trial is being led from the UK, we expect it to deliver global impact for brain cancer patients.

This trial has been named the Tessa Jowell BRAIN-MATRIX in honour of Baroness Tessa Jowell, who bravely shared her diagnosis of a brain tumour on her 70th birthday. Following that revelation Tessa used her influence as a former minister to work towards 'more people living longer better lives with cancer'. She was a strong advocate for adaptive clinical trials and for enabling people to share their data to improve the understanding of these terrible diseases. Both of these ideals are the core foundations that were also driving our researchers when they developed BRAIN-MATRIX.

What's so special about this trial?

This is an adaptive trial because, at the time the study opens, the researchers don't know exactly what treatments will be tested. The adaptive design means that as new, possibly better, treatments become available they can be added to new 'arms' of the study and patients can have access to them immediately. This trial will essentially pave the way for future drug treatments to be tested faster.

The new drug treatments will probably only be effective against a subset of tumours, with particular molecular profiles. All the tumours in this trial will have had a molecular diagnosis at the outset, so there won't be any need for further surgery, and participants can move straight on to the new treatment arm.

These new arms can then be tested more quickly and compared with the control arm, meaning more people will get a therapy we think might work better than the current standard of care. This is particularly powerful because all the systems will be in place and the time saving will be huge.

Who'll be eligible for the trial?

The criteria are relatively wide, meaning the 10 UK neurocentres taking part will be able to offer the trial to everyone (both adults and children) who has a grade 2, 3 or 4 glioma tumour and is able to undergo a surgical procedure, including biopsy.

Where will the trial be run?

This ground-breaking trial is under the leadership of Professor Colin Watts. Colin is Professor of Neurosurgery at the Queen Elizabeth Hospital Birmingham and Chair of the University of Birmingham's Brain Cancer Program. Along with Birmingham, the initial centres that will be able to recruit people onto this trail are in Edinburgh, Leeds, Kings College London, Cambridge, Glasgow, Liverpool, Manchester, Nottingham and Oxford.

All of these locations house major referral centres for people with a suspected glioma, and it means that the majority of people in Scotland and England with a brain tumour will come under their care.

How will the trial work?

In the first phase of the trial, everyone who takes part will have surgery or a biopsy. The tumour that is removed will then be tested so participants, and the researchers, will know the molecular profile of their tumour. This is called molecular diagnosis.

By default all participants will originally be enrolled onto “Arm 0" (the control arm) of the study. All participants in Arm 0 will receive the current gold standard treatment, along with added monitoring that all clinical trial participants are eligible for.

Arm 0 is really important because this is where the bulk of participants will start out, and because all new treatments will be compared to Arm 0 to see which treatments produce better outcomes.

As new drugs are developed or repurposed additional arms will be added to the study to incorporate them, always compared back to the treatments in Arm 0.

The first planned experimental arm – Arm 1 - is for people whose tumour contains a specific mutation called BRAF V600E. These people will then have a new treatment, which has been designed to work against the effects of a BRAF V600E mutation, and should slow tumour growth.

Everyone on the trial will also contribute their data to BRIAN, The Brain Tumour Charity's brain tumour databank.

BRIAN will offer a unique service enabling participants to combine official medical records with real-time patient information about their diagnosis, treatment and the impact on quality of life.

When does the trial start?

The first official day of funding will be in early 2019, though some of the ground work has already begun. Throughout 2019 the team will be working hard to get everything set up for the formal trial opening, and they aim for the first person to be recruited within a year.

The set up for this study will take longer than some other trials because it is planning for the future and aiming to cover such a large recruitment area.

What happens between now and when the first patient is recruited?

Every clinical trial has to go through strict checks on ethics, as well as get approval for new drugs to be used before the first person can join up.

These permissions can take months to achieve, because we want to make sure everyone on the trial knows that it has been well designed, and that the drugs they're given are appropriate for the use intended.

Not only will the team be applying for all the appropriate ethical and governmental approvals, they'll also make sure that, as soon as there are new drug candidates for other molecular profiles, they can open a new treatment arm.

From the very beginning the trial team will be working with industry partners to gain access to their most promising drugs. In fact, discussions are already taking place, because researchers are so enthusiastic about this trial.

How long will the trial continue?

The first phase of funding for the trial is for 5 years (including the set up period). This includes time to analyse the different treatments and publish the outcomes.

What is a molecular profile?

A molecular profile looks for changes (mutations) in the tumour profile compared to the non-tumour profiles (in other words, the norm). Different combinations of changes (different molecular profiles) cause different brain tumours.

It's important to understand what molecular profile a tumour has, because some drugs only work on certain profiles, and this ensures doctors can give treatments that will work best in each case.

Find out more about biomarker testing

I’ve got a glioma – how do I get on it?

At the moment the trial is not open for recruitment. We'll make an announcement at a later date and then, if you're interested in enrolling you'll need to discuss it with your consultant. The Brain Tumour Charity is NOT able to enrol you directly onto the trial.

What if I’m not being treated at one of the 10 centres?

At the moment the trial is not open for recruitment. If you are not being treated at one of the recruitment centres and are interested in the trial please discuss it with your consultant. You may still be able to be involved in the trial, however you will need to be able to travel regularly to one of the centres. The Brain Tumour Charity are NOT able to enrol you directly onto the trial.

How does BRIAN fit in?

One of the most important things that a clinical trial can do for the patients of the future is to collect really good quality data from people going through the new treatments. The data will be used to find patterns in treatment-response and to form new questions that need to be researched.

All the participants of the Tessa Jowell BRAIN-MATRIX study will be contributing their information, e.g. imaging and molecular test results, to BRIAN. As this is an inbuilt part of the trial, the data collected will be more complete, and therefore of the best quality possible.

A great strength of BRIAN is that it will collect data from clinical sources (i.e. doctors) but it will also enable participants to record their own observations too. In this way people will be able to share what it is really like to be living with a brain tumour, and they will be able to compare their experiences with others going through the same thing.

If you are living with a brain tumour and interested in contributing to BRIAN, you don't have to be on any studies, just have your NHS number to hand.

Join BRIAN

What does it hope to achieve?

This is a study to set up a system in the UK to enable patients with glioma to be given treatments specific to their cancer, with the goal of reducing side effects and increasing survival.

At the end of this study researchers aim to have opened more targeted treatment trials (arms) for people with brain tumours in a shorter time than ever before.

They will have tested whether it is possible to get a molecular profile of a brain tumour fast enough to influence which treatment is offered.

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