A trial looking at vemurafenib after surgery for melanoma (BRIM 8)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Melanoma

Skin cancer

Status:

Closed

Phase:

Phase 3

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

Find out if vemurafenib can reduce the risk of melanoma coming back, or delay it
Learn more about how vemurafenib works in the body
Learn more about the side effects

Who can enter

You may be able to join this trial if all of the following apply.

You have melanoma that is either stage 2c or stage 3
If you were found to have cancer in your lymph nodes, these have been removed with surgery (lymph node dissection) with no sign of the cancer coming back in the surrounding area
You have melanoma with a change (mutation) in a gene called BRAF (sometimes called BRAF positive), the trial team will test for this
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You have satisfactory blood test results
You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance that you or your partner could become pregnant
You are at least 18 years old

If you have had one of the following, you must have had an examination of your bowel (colonoscopy Open a glossary item ) in the last year (or during screening for the study) and the colonoscopy must not show any signs of cancer

Specific polyps removed from your bowel
Bowel cancer
Possible symptoms of bowel cancer that needed investigating
A significant family history of bowel cancer (the trial team can explain this to you)

You cannot join this trial if any of these apply. You

Have melanoma that has spread from where it started to another part of your body (distant metastases)
Have had major surgery in the last 4 weeks
Have already had medication by mouth or through a drip to treat melanoma or to try to prevent it coming back, for example chemotherapy or biological therapy
Have already had a local treatment to treat melanoma or to try to prevent it coming back, such as radiotherapy, photodynamic therapy or chemotherapy into an arm or leg
Have had treatment in a clinical trial in the last 4 weeks
Have an inherited condition or syndrome in your family that increases the risk of bowel cancer, such as familial adenomatous polyposis (FAP) or hereditary non polyposis colorectal cancer (HNPCC)
Have had any other cancer in the last 5 years, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
Have had radiotherapy to treat prostate cancer, cervical cancer or rectal cancer in the past
Have not yet recovered fully from surgery
Have certain heart problems (the trial team can advise you about this)
Have an infection that needs treatment
Are known to be HIV, hepatitis B or hepatitis C positive
Are allergic to the drugs used in this trial, anything they contain, or to similar drugs
Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
Are pregnant or breastfeeding

Trial design

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.

People in one group have vemurafenib
People in the other group have a dummy drug (placebo)

10671 Trial Diagram

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

Before you start treatment
Every 4 weeks during treatment
Four weeks after you finish treatment
Every 3 months for up to 5 years from the first day of treatment, or until the melanoma comes back (whichever happens first)

The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Blood tests
Physical examination
Skin exam
Pelvic exam (for female patients)
Heart trace (ECG )
CT scan or MRI scan of your chest, stomach (abdomen) and pelvis and of your brain
Stool test – to test for blood that cannot normally be seen

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

Every week for the first 4 weeks
Every 2 weeks during the second month
Then every 4 weeks until you finish treatment

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 ECGs Open a glossary item 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.

Side effects

The most common side effects of vemurafenib may include

Aching joints and muscle pain
Tiredness (fatigue)
Skin rash and dry itchy skin
Sensitivity to sunlight - while you are having treatment (and for 5 days after you finish treatment) avoid being in the sun, cover up and use sunscreen on exposed areas
Feeling or being sick
Hair loss
Diarrhoea
Loss of appetite
Headaches
Taste changes
Swelling in arms and legs due to build up of fluid
Pain in hands and feet
High temperature for a few hours after treatment
Warts on the skin (papilloma) and thickening of the skin (hyperkeratosis)
Increased risk of non melanoma skin cancers, such as squamous cell skin cancer - the trial doctor will check your skin during and after treatment, so if you do develop a non melanoma skin cancer it will be found early when it is curable with surgery

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.