
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
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.
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 looks normal. This blood test aims to pick up DNA in the blood from cancer cells. This is called circulating tumour DNA or
.
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:
Nivolumab is an immunotherapy. It is already a treatment for melanoma that has spread. It helps the to find and kill cancer cells.
The main aims of the trial are to find out:
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:
Who can’t take part
You cannot join this trial if any of these apply. You:
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:
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:
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 () 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:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial doctor and have some tests before you can take part. These include:
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:
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:
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.
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:
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Paul Lorigan
Cancer Research UK
The Christie NHS Foundation Trust
This is Cancer Research UK trial number CRUK/19/010.
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”