
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.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at the use of vemurafenib for people who have had surgery to remove melanoma skin cancer.
Doctors often treat melanoma with surgery. Even when the cancer has been completely removed, it can sometimes come back (recur). Doctors are looking for new treatments that can reduce the risk of this happening.
Vemurafenib is a type of biological therapy called a cancer growth blocker. It stops cells producing a protein called BRAF, which makes some cancer cells grow and divide.
Vemurafenib is already used to treat some people with advanced melanoma. Doctors want to know whether this drug would help people with earlier stage melanoma who have a high risk of their cancer coming back.
The aims of the trial are to
You may be able to join this trial if all of the following apply.
If you have had one of the following, you must have had an examination of your bowel () in the last year (or during screening for the study) and the colonoscopy must not show any signs of cancer
You cannot join this trial if any of these apply. You
This is a phase 3 trial. The researchers need 475 people to join.
This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
You have vemurafenib or your dummy tablets (placebo) every day. You have 4 tablets twice a day, about 12 hours apart. You should take your tablets with food or shortly after eating.
You have treatment for up to 1 year. If you have bad side effects, or your melanoma comes back during this time, or you are diagnosed with another melanoma, you will stop treatment as part of this trial. You doctor will discuss further appropriate treatment with you.
The trial team will ask you to fill out a questionnaire
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You will see the doctors and have some tests before you start treatment. The tests include
Before you join this trial the trial team need to make sure that you do not have certain cancers, or pre cancers. So as well as a physical examination by the trial doctor, you will be also be examined by some specialist doctors. For example, a skin specialist, a head and neck specialist and a gynaecologist for women. The trial team will explain this to you in more detail.
You go to hospital
At these appointments you will see the doctor and have blood tests. The doctor will ask about any side effects you are having.
You have every 2 weeks for the first 8 weeks, then every 12 weeks during treatment. You may have these more often if you doctor thinks you need them.
You have a CT or MRI scan of your chest, stomach (abdomen) and pelvis at least every 3 months.
You have an appointment 1 month after you finish the trial treatment. At this appointment, you will have some of the tests you had when you joined the trial.
Once you have finished treatment, and if your melanoma has not come back, you go to hospital every 3 months for about 4 years. You will have blood tests (less than during the treatment), a physical examination and further scans. A doctor or nurse from the trial team may then contact you every 3 months for a further 2 years to check how you are.
The most common side effects of vemurafenib may include
We have more information about vemurafenib. If any new information is learnt about the side effects of this drug, the trial team will let you know more about this.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Mark Middleton
Experimental Cancer Medicine Centre (ECMC)
F. Hoffmann - La Roche Limited
Freephone 0808 800 4040
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.