
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called vemurafenib (Zelboraf), also known as RO5185426, for children with advanced melanoma that cannot be removed with surgery. Doctors can already use vemurafenib to treat adults with melanoma.
This trial is for children and young people from age 12 up to and including the age of 17. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.
Doctors can use chemotherapy to treat advanced melanoma that can’t be removed with surgery. But it doesn’t always work very well. In this study they want to look at a drug called vemurafenib, which has helped some adults with advanced melanoma.
Vemurafenib is a type of biological therapy called a BRAF inhibitor. BRAF is a body protein that sends signals to cells telling them to divide and grow. Blocking BRAF may stop cancer cells growing.
Certain changes in the BRAF cause a change in the BRAF protein that can increase the growth and spread of cancer cells. When you join the trial you will have a test to see if your melanoma cells have an altered BRAF gene (a particular
). Doctors can already use vemurafenib to treat adults with melanoma that cannot be removed with surgery, or that has spread to another part of the body, if they have this gene mutation.
The aims of this study are to find out
You may be able to enter this trial if you
You cannot enter this trial if you
This study is in two parts. Everyone taking part will take vemurafenib tablets daily.
People in the first part of the study will have the lowest dose of vemurafenib. If they don’t have any serious side effects, the next people will have a higher dose, and so on, until they find the best dose to give. This is called a dose escalation study. The dose you have will depend on when you join the trial.
In the second part of the study everyone will have the best dose of vemurafenib found in the first part. You can take vemurafenib tablets for as long as they are helping you.
People who took part in the dose escalation study can continue taking vemurafenib at the best dose.
If you agree to take part in either part of this study, the researchers will ask for a sample of tissue taken when your cancer was diagnosed. If this is not available then you will need to have a tissue sample () of your cancer taken. Doctors need this to find out if your cancer has the change to the BRAF gene.
You will see the doctors and have some tests before you start treatment. The tests include
You have these tests often while you are having treatment.
You have CT scans or MRI scans every 8 weeks for a year and then every 12 weeks until the cancer gets worse.
You have a PET scan after 8 weeks of treatment.
When you stop taking vemurafenib you see the trial team 30 days later for a physical examination and blood tests. The trial team will then contact you every 3 months to see how you are.
The most common side effects of vemurafenib are
Your doctor will talk to you about the possible side effects before you agree to take part in this trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Julia Chisholm
NIHR Clinical Research Network: Cancer
Roche
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.