
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at 2 drugs called encorafenib and binimetinib before and after surgery for melanoma.
It is for people:
Surgery is a usual treatment for melanoma that has spread to the lymph nodes or other parts of the body. You might also have a targeted cancer drug after surgery. The cancer drug you have depends on how far the cancer has spread. You might have:
Doctors are looking for ways to improve treatment. In this trial they are looking at a combination of drugs that include encorafenib and binimetinib. This is already a treatment for melanoma that has spread elsewhere in the body and it isn’t possible to have surgery to remove it. Doctors now want to see how well it works for melanoma that the surgeon can completely remove.
We know from research that having encorafenib and binimetinib before surgery might stop the melanoma coming back. Researchers don’t know this for sure, so they are doing this trial to find out more.
In this trial some people have encorafenib and binimetinib before and after surgery. And some people have surgery followed by standard cancer drug treatment. This is the treatment that people have if they don’t take part in a trial.
The main aims of the trial are to find out:
The trial team hope to run a larger trial if this one is successful.
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if you are pregnant, planning to become pregnant or breastfeeding.
This is a phase 2 trial. The trial team need 45 people to take part.
It is a randomised trial. A computer puts you into a treatment group. In this trial, 2 out of every 3 people have encorafenib and binimetinib. And 1 out of every 3 people standard cancer treatment.
There are 2 are groups:
Encorafenib and binimetinib group
Encorafenib and binimetinib are tablets. You have encorafenib and binimetinib for 8 weeks before surgery. You have treatment in cycles. Each 4 week period is a.
You take:
You then have surgery as planned. This is the same surgery you would have whether you were in the trial or not.
After surgery you have encorafenib and binimetinib for up to 44 weeks. This is as long as it is working and the side effects aren’t too bad. You start it within 12 weeks of surgery. You have it as described above.
You won’t be able to continue to have encorafenib and binimetinib after surgery if the surgeon can’t remove all of the cancer. The trial team will discuss the treatment options with you if this happens.
Standard treatment group
You have your surgery as planned. This is followed by a standard cancer drug. The treatment you have depends on how far the cancer has spread.
You either have:
You start treatment within 12 weeks of surgery. Your doctor can tell you which treatment you’ll have and how often you have it.
You have this for up to 1 year after surgery as long as treatment is working and the side effects aren’t too bad.
Quality of life
The trial team ask you to fill out some questionnaires:
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
Blood and tissue samples
The researchers take some extra blood samples. Where possible, you have these at the same time as your routine blood tests. They also need a that they take from the melanoma during surgery.
They plan to use the samples to:
The trial team also ask to take a tissue sample if the cancer gets worse.
You see a doctor and have some tests before you join the trial. These include:
Encorafenib and binimetinib group
You see the trial team once a month before surgery. In week 3, a member of the team will call you to find out if you are having any side effects.
After surgery you see the doctor once a month for a check up. Some of the consultations might be a phone or video call. You’ll still need to go to the hospital at least every 3 months for a check up.
Standard treatment group
Your healthcare team can let you know how often you have treatment at the hospital. This depends on the cancer drugs you are having.
You see the trial doctor at least every 6 weeks. Some of these appointments might be video or phone calls. You still need to go to the hospital at least every 12 weeks for a check up.
Both groups
Everyone in the trial has a CT scan, PET-CT scan or MRI scan every 3 months. You stop the trial scans if your cancer gets worse.
You see the trial team one month after you finish treatment for a check up. After that you see them once every 3 months.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of binimetinib in combination with encorafenib include:
Most of the side effects of binimetinib and encorafenib are mild and manageable.
We have more information about the following drugs and their side effects:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Pippa Corrie
Cambridge University Hospitals NHS Foundation Trust
Cambridge Clinical Trials Unit - Cancer Theme
Pierre Fabre Ltd, UK
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.