Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at vemurafenib in children with advanced melanoma (BRIM-P)
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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.
More about this trial
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
The aims of this study are to find out
- The best dose of vemurafenib to give
- How well it works
- About the side effects
- What happens to vemurafenib in your body
- How quickly the body gets rid if it
Who can enter
You may be able to enter this trial if you
- Have stage 3C or 4 melanoma that cannot be removed with surgery
- Have melanoma cells that have the BRAF gene change
- Have melanoma that can be measured on a CT scan or MRI scan
- Are well enough to be up and about for at least half the day, Karnofsky performance status 60% - 100% if you are over 16 or have a Lansky play score of 60% - 100% if you are under 16
- Have fully recovered from any surgery
- Are able to swallow tablets
- Have satisfactory blood test results
- Are willing to use reliable contraception during treatment and for 6 months afterwards if you are sexually active and there is any chance that you or your partner could become pregnant
- Are between 12 and 17 years old
You cannot enter this trial if you
- Have had chemotherapy, biological therapy, radiotherapy or surgery in the last 2 weeks
- Have melanoma that has spread to the brain or spinal cord and is causing you problems
- Still have any side effects from previous treatment
- Have had treatment with a
nitrosoureain the last 4 weeks
- Have had radiotherapy to your head, spine or the area between your hips (pelvis) in the last 3 months
- Have had vemurafenib before
- Have had a type of drug called a BRAF Inhibitor or
MEK inhibitorbefore, unless it was sorafenib
- Have had cancer in your back that caused you problems (spinal cord compression)
- Have had treatment on a trial in the last 4 weeks
- Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 5 years ago
- Are pregnant or breastfeeding
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 (
You will see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- Heart trace (
- Urine tests
- CT scan or MRI scan
- PET scan
- Skin examination
- Having a sample of tissue taken (
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
- Hair loss
- Feeling or being sick
- Tiredness (fatigue)
- Increased sensitivity to sun light
- Aching joints and muscle pain
- Itchy skin
- Changes in your skin including skin tags or thickening of the skin
- Non harmful skin cancers, including squamous cell and basal cell cancers happen in about a quarter of people (25%) – let your doctor know if you notice any skin changes
Your doctor will talk to you about the possible side effects before you agree to take part in this trial.
How to join a clinical trial
Dr Julia Chisholm
NIHR Clinical Research Network: Cancer