Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of MEK162 for melanoma that cannot be removed with surgery or has spread to another part of the body (NEMO)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Melanoma
Secondary cancers
Skin cancer
Status:
Closed
Phase:
Phase 3
This trial is comparing a new drug called MEK162 with dacarbazine chemotherapy for melanoma that can’t be removed with surgery, or has spread to another part of the body. It is for people who have melanoma with a change to a gene called NRAS.
If melanoma can’t be removed with surgery, doctors often use a chemotherapy drug called dacarbazine to treat it. But researchers are looking for new treatments to help people in this situation. In this trial they are looking at a drug called MEK162.
MEK162 is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
Researchers think that MEK162 may help people who have melanoma with a change to a gene called NRAS. The aim of this trial is to see if MEK162 works better than dacarbazine for this group of people.
Who can enter
You may be able to enter this trial if you
- Have melanoma that can’t be removed with surgery or has spread to another part of your body (stage 3C or stage 4)
- Have a change to a gene called NRAS in your melanoma cells
- Have not had any other treatment for melanoma, or your melanoma has got worse despite having other types of treatment
- Have at least one area of melanoma that can be seen and measured on a scan or photograph of your skin
- Have satisfactory blood test results
- Have satisfactory results from tests to check how well your heart is working
- Are at least 18 years old
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are able to swallow tablets
- Are willing to use reliable contraception during the trial and for 30 days afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have melanoma that has spread to your brain or spinal cord unless this has been successfully treated with surgery or stereotactic radiotherapy, has not got any worse for at least 4 weeks after treatment, and you haven’t taken
steroids 
for at least 3 weeks - Have melanoma that has spread to the tissues that surround your brain (leptomeningeal metastases)
- Have melanoma that started in your eye (uveal melanoma) or in the moist tissues that line some parts of your body (
mucosal melanoma ) - Have had a drug called ipilimumab in the last 6 weeks
- Have had chemotherapy for melanoma that can’t be removed or has spread (you may have had chemotherapy after surgery to remove melanoma to try to stop it coming back)
- Have already had a drug that works in the same way as MEK162 (a MEK inhibitor)
- Have had major surgery or radiotherapy in the last 3 weeks
- Have certain eye conditions, such as ocular hypertension or glaucoma that isn’t controlled with medication (the trial team can advise you about this)
- Have had any other cancer in the last 5 years apart from non melanoma skin cancer that was successfully treated, or very early stage cervical cancer (carcinoma in situ of the cervix) that was successfully treated at least 3 years ago
- Have had a bone marrow transplant using cells from a donor or
organ transplant - Have a condition affecting your liver called Gilberts syndrome
- Are known to be HIV, hepatitis B or hepatitis C positive
- Have a serious heart condition (the trial team can advise you about this)
- Have high blood pressure that can’t be controlled with medication
- Have certain problems with your
digestive system (the trial team can advise you about this) - Have a medical condition affecting your muscles (the trial team can explain this)
- Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
- Are planning on starting new, strenuous exercise during the trial (the trial team can explain this)
- Are pregnant or breastfeeding
Trial design
This phase 3 trial will recruit nearly 400 people. It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
People in 1 group have MEK162. People in the other group have dacarbazine. There will be twice as many people in the group having MEK162 as in the group having dacarbazine.
If you are having dacarbazine, you have it as an injection into a vein once every 3 weeks. It takes between 20 minutes and an hour. If you are having MEK162, you take 3 tablets twice a day.
As long as you don’t have bad side effects, you can carry on having MEK162 or dacarbazine for as long as it is helping you.
The trial team will ask you to fill out a questionnaire before you start treatment, at set times during the trial and when you stop treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
To find out if you are suitable for the trial, the researchers need to make sure your melanoma has a change to the NRAS gene. So they will send a sample to the lab. This can be a stored sample of melanoma removed when you had a or surgery in the past. If there isn’t a sample of your melanoma stored, you will need to a have a new biopsy.
You see the trial team and have some tests before you start treatment.
The tests include
- Physical examination
- Urine test
- Heart scan (
echocardiogram or MUGA scan ) - CT scan or MRI scan
- Bone scan
- Heart traces (
ECGs ) - Eye test
- Blood tests
- Photographs of any areas of melanoma on your skin
You go to hospital every 3 weeks while you are having treatment. You have regular blood tests, eye tests, heart traces, scans and urine tests.
A month after you finish treatment, you see the trial team again and have some more tests and scans. They will then contact you by phone or email every 3 months to see how you are and whether you are having any other treatment for your melanoma.
If you stop having treatment for any reason other than your melanoma getting worse, the trial team will ask you to carry on having a CT or MRI scan every 9 weeks until your melanoma does start to get worse or you start another treatment.
Side effects
As MEK162 is a new drug, there may be some side effects we don’t yet know about yet. Possible side effects include
- Diarrhoea
- Tiredness (fatigue)
- Feeling or being sick
- Constipation
- Dry or sore mouth
- Indigestion
- Joint Pain
- Weight gain and swelling due to fluid retention
- Loss of appetite and taste changes
- High blood pressure
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Changes to your nails
- Muscle weakness and pain
- Blurred vision and changes to the light sensing part of the back of the eye
- Swelling around the eye
- Skin redness, itching, dryness and cracking
The most common side effects of dacarbazine include
- Feeling or being sick
- Tiredness (fatigue)
- Loss of appetite
- Flu like symptoms
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Cough
- Sore throat
- Dizziness
- Low blood pressure
- Increased skin sensitivity to sunlight
- Pain at the injection site while you have the drug
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Dr James Larkin
Supported by
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Novartis
Questions about cancer? Contact our information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
Oracle 10622
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Around 1 in 5 people take part in clinical trials
Last reviewed:
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