A trial of a blood test to monitor for early signs of melanoma coming back (DETECTION)

Cancer type:

Melanoma
Skin cancer

Status:

Open

Phase:

Phase 2/3

This trial is measuring small amounts of melanoma cancer cells that may be in the bloodstream after surgery. 

Depending on the results some people go on to have treatment with a drug called nivolumab. 

The trial is for people who have early stage melanoma. This is stage 2B or 2C melanoma

Cancer Research UK supports this trial. 

More about this trial

Surgery is the usual treatment for melanoma that hasn’t spread. It gets rid of the cancer in most people. But sometimes it comes back or spreads elsewhere in the body. So researchers are looking for ways to treat people before this happens. 

The trial team have developed a blood test to look for cancer cells in the blood even if a scan Open a glossary item looks normal. This blood test aims to pick up DNA in the blood from cancer cells. This is called circulating tumour DNA or ctDNA Open a glossary item.

We know from research that people who have ctDNA in their blood have a higher chance of the cancer coming back. You usually only have treatment if a scan shows that this has happened. Doctors think that having treatment earlier if you have ctDNA in your blood could help. But they aren’t sure so want to find out more. 

In this trial you have regular ctDNA blood tests after surgery. You then have one of the following if the team find cancer cells in the blood:

  • continue with regular ctDNA blood tests, routine scans and check ups
  • nivolumab

Nivolumab is an immunotherapy. It is already a treatment for melanoma that has spread. It helps the immune system Open a glossary item to find and kill cancer cells. 

The main aims of the trial are to find out:

  • how well the ctDNA blood test works to find cancer cells
  • if ctDNA picks up that the melanoma is coming back earlier than scans
  • if having nivolumab works for people who have ctDNA detected in their blood, prevents the cancer from coming back and improves how long they live 

Who can enter

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:

  • have early stage melanoma. This is melanoma that is stage 2B or stage 2C.
  • have had your cancer completely removed by surgery in the 12 weeks before you join the trial. You must have had a sentinel lymph node Open a glossary item biopsy to check for cancer cells in the lymph nodes.
  • have had a scan and tests that show you have no signs of melanoma within a month of joining this trial
  • have at least one gene change (mutation) on the BRAF gene or NRAS gene on your melanoma cells. You have a blood test to check this. 
  • are well enough to carry out all your normal activities but might not be able to do heavy physical work (performance status of 0 or 1)
  • have satisfactory blood tests results
  • are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant 
  • are at least 16 years old

Who can’t take part

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

  • have had immunotherapy Open a glossary item, chemotherapy, cancer vaccines Open a glossary item or certain targeted drugs Open a glossary item such as dabrafenib and trametinib. 
  • have an autoimmune condition Open a glossary item that needs treatment apart from certain ones. Your doctor will know about this. 
  • have or have had another cancer in the last 3 years. You may be able to join the trial if you have non melanoma skin cancer Open a glossary item.
  • have had treatment that damps down the immune system Open a glossary item. This includes steroids within 3 months of starting trial treatments unless it was a low dose.
  • have a condition called interstitial lung disease that is causing symptoms. Or the doctor thinks that it may affect noticing any lung side effects that treatment may cause.
  • are allergic to nivolumab, monoclonal antibodies Open a glossary item or anything they contain
  • have HIV, hepatitis B or hepatitis C 
  • have had any other medical condition or mental health problem that the trial doctor thinks could affect you taking part in this trial

Trial design

This phase 2/3 trial is taking place in the UK and Australia. The team need to find 1,050 people to take part. This includes 900 from the UK. 

To begin with the team ask your permission to get a sample of your cancer when you had surgery to remove it. They analyse these samples. They are looking for certain gene changes in your melanoma cells. You can only join the trial if they find these gene changes. 

Your doctor will talk to you about other treatment options if you don’t have these genes present. 

Looking for cancer DNA in the blood (ctDNA blood test)
After surgery you have a ctDNA blood test every 3 months. It aims to detect any ctDNA in the blood coming from cancer cells. 

During the trial neither you nor your doctor will know the results of the ctDNA blood tests.

If the team don’t find ctDNA from cancer cells this means you are ctDNA negative. You carry on having the blood tests every:

  • 3 months for 3 years and then
  • every 6 months for a further two years

You also continue to have your routine check ups and scans. If they find ctDNA then you are put into one of the trial groups.

Trial groups
Your test is positive if the team find ctDNA in the blood. You then join the randomised part of the trial. There are 2 groups. A computer puts you into a group.  Neither you nor your doctor will be able to decide which group you are in. 

You have 1 of the following:

  • continue to have regular ctDNA blood tests. You also have your routine scans and check ups. This is the standard care group A. 
  • nivolumab (group B)

In group A you only have further treatment if your cancer comes back. Your doctor will talk to you about treatment options if this happens. 

In group B you have nivolumab as a drip into a vein. You have it once a month. It takes about 60 minutes each time. You have it for up to 2 years as long as it is working and the side effects aren’t too bad. You stop nivolumab if your cancer comes back. Your doctor will talk to you about further treatment options. 

Samples for research
The team ask you to give some extra blood samples. Where possible you give these at the same time as your routine blood tests. 

They also ask you to give an extra tissue sample (biopsy Open a glossary item) if your cancer comes back. 

The team plan to use the samples to find out more about the immune system and why nivolumab works for some people and not others.

The team would also like to examine poo samples. They plan to look at the bacteria in your gut and how these change with treatment. The team give you a kit and instructions on how to collect the sample. 

You should collect the sample at home less than 24 hours before your appointment when you can drop it off.

You don’t have to agree to give the tissue or poo samples if you don’t want to. You can still take part in the rest of the trial.

Quality of life
The trial team ask you to fill out a questionnaire:

  • before you start treatment
  • at set times during treatment

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

Hospital visits

You see the trial doctor and have some tests before you can take part. These include:

  • blood tests
  • a physical examination Open a glossary item
  • heart trace (ECG Open a glossary item)
  • CT scan

Some people may have an MRI scan or PET-CT scan
 
In group A you go to hospital for a check up and blood tests:

  • every 3 months for 3 years and then 
  • every 6 months for the next 2 years 

In group B you have nivolumab at the hospital on the day care ward. During treatment you see the trial doctor once a month for a check up. You also have a check up within a month of finishing treatment and then:

  • every 6 months if your cancer hasn’t come back 
  • every 3 months if your melanoma has come back 

Scans 
During the trial everyone has a CT scan every 6 months. Some people have a PET-CT scan or an MRI scan instead of a CT scan. 

Side effects

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. 

Nivolumab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.

If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

Nivolumab might cause a serious lung problem. Please contact your trial doctor or nurse straight away if you have any of the following:

  • a new or worsening cough
  • new or increased mucus or blood in your cough
  • new or worsening shortness of breath or other breathing problems
  • a change in the amount of oxygen you need if you have extra oxygen
  • a fever, tiredness (fatigue) or other symptoms that happen at the same time as any changes to your breathing or other lung symptoms

You may need to have some extra tests to find out what is causing these lung symptoms. Your doctor can tell you more about this if needed. 

The most common side effects of nivolumab include:

The trial doctor will talk to you about all the possible side effects of nivolumab. You’ll have a chance to ask any questions you may have. 

We have more information about nivolumab.

Location

Cambridge
Glasgow
Manchester
Nottingham
Oxford

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

Professor Paul Lorigan

Supported by

Cancer Research UK 
The Christie NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUK/19/010.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17882

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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