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.