A trial looking at nilotinib to treat acral and mucosal melanoma skin cancer that has spread (NICAM)

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

Cancer type:

Skin cancer




Phase 2

This trial is looking at using nilotinib to treat melanoma skin cancer that has spread to the surrounding tissues, or to another part of the body. It is for two unusual types called acral melanoma and mucosal melanoma. This trial is supported by Cancer Research UK.

Acral melanoma (sometimes called ‘lentiginous melanoma’) is a type most commonly found on the palms of the hands or soles of the feet. Mucosal melanoma Open a glossary item is a rare type of melanoma that starts in the moist tissue (mucosa) which lines the mouth, nose, food pipe, anus, vulva and vagina.

Doctors can use chemotherapy to help people with advanced melanoma, but this is only to relieve their symptoms. They are always looking for new ways to improve treatment for people with advanced melanoma.

Tyrosine kinases Open a glossary item are chemical messengers that tell all cells to grow and divide. We know from research that some melanoma cells may have overactive tyrosine kinases, so there are many messages telling the cancer to grow.

Nilotinib is a type of biological therapy called a tyrosine kinase inhibitor (TKI for short). TKIs block tyrosine kinases. And so the researchers think that nilotinib may help stop the growth and spread of melanoma.

The aims of this trial are to find out

  • If nilotinib can help people with advanced acral and mucosal melanoma
  • How safe nilotinib is for this group of people
  • What the side effects are

Who can enter

You can enter this trial if

  • You have melanoma on the palms of the hand or soles of the feet (acral melanoma) or that started in the moist tissue of the body like the mouth, nose, food pipe, vulva or anus (mucosal melanoma Open a glossary item)
  • Your melanoma has spread to the surrounding tissues (stage 3B or 3C) or spread to another part of the body (stage 4)
  • Your melanoma cannot be removed with surgery
  • You have one or more tumours of at least 10mm that can be measured
  • You have satisfactory blood test results
  • You are up and about for more than half the day and can look after yourself but are not well enough to work (performance status 0, 1, 2)
  • You are willing to use reliable contraception if there is a chance to you or your partner could become pregnant
  • You are at least 18 years old

You cannot enter this trial if you

  • Have melanoma that has spread to your brain – you may be able to join if a scan shows that this spread has been stable for 6 months or more, or if you have had surgery to remove a single area of melanoma spread at least 3 months ago and the disease is no worse
  • Are taking steroids to treat melanoma spread to the brain
  • Have had a another drug similar to nilotinib ( a ‘tyrosine kinase inhibitor’) before – your doctor can advise about this
  • Have had radiotherapy in the last 4 weeks
  • Have had radiotherapy to a quarter or more of the bones in your body that make blood cells
  • Have a serious heart problem
  • Have ongoing liver problems
  • Have ongoing problems with your pancreas
  • Have problems absorbing tablets in your gut
  • Are not able to digest a sugar (lactose) found in milk and milk products - this is called ‘lactose intolerance’
  • Are known to be HIV positive
  • Have another medical problem that could affect you taking part in this trial
  • Have had another drug as a part of a clinical trial in the last month
  • Use herbal medicine
  • Use Chinese herbal medicine
  • Are taking a drug that thins your blood, such as warfarin

Trial design

This is a phase 2 trial. It will recruit about 120 people in the UK. This trial is in 2 parts.

In the first part of this trial, the researchers need to find out if your melanoma has an overactive c-KIT tyrosine kinase Open a glossary item on the surface of the cancer cells. To do this they will ask your permission for a sample of tissue from when you had your biopsy or surgery. If there is an overactive c-KIT tyrosine kinase this is called ‘c-KIT positive’.

If your melanoma is c-KIT positive, the trial team will talk to you about the next part of the trial. If your melanoma is not c-KIT positive you will not be able to take part in the second part of the trial and your doctor will discuss your treatment options with you.

In the second part of the trial, everyone taking part will have nilotinib tablets. You take 2 tablets twice a day (12 hours apart) at about the same time each day. You swallow them whole with a glass of water on an empty stomach. You should wait at least 2 hours after eating before taking them. And after you have taken your capsules don't eat for an hour.  

Exactly how long you carry on taking nilotinib will depend on how well you are, and if it is still helping.

If you take part in this trial, the researchers will ask your permission to take

  • Tissue samples
  • Skin samples
  • A few hairs from your head
  • Blood samples

These samples will be stored safely and only used for research purposes. Studying these samples may help researchers learn more about the type of melanoma you have and how nilotinib may help.

You can choose to give permission for the researchers to take none, some or all of these samples. Your decision will not affect you taking part in the main trial.

Hospital visits

You will see the doctor and have some tests before you start treatment. These tests include

  • Finding out if your melanoma is ‘c-KIT positive’
  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Blood tests
  • CT scan
  • Pregnancy test (if appropriate)

During treatment you see the doctor on the 15th and 29th day of your treatment. You then see them every 4 weeks to the end of 1 year, then every 8 weeks after that. When you see the doctor, you have the following tests

  • Physical examination
  • Heart trace (ECG)
  • Blood tests

During treatment you also have a CT scan every 3 months.

If you stop treatment because of the side effects, you will see the doctor every 6 weeks and have the following tests

  • Physical examination
  • Blood tests
  • CT scan

If you stop treatment because it is not helping, your doctor will discuss what other treatment options may be available.

Side effects

You cannot eat certain fruits, or drink their juice, while having nilotinib. This is because they can interfere with the way nilotinib works and may increase the side effects. They include

  • Grapefruit
  • Star fruit
  • Pomegranate
  • Seville oranges (other types of oranges are allowed)
  • Anything with Seville oranges in it, such as marmalade

The side effects of nilotinib may include

You can find more about nilotinib on CancerHelp UK.

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

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUK/09/028.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 4274

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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