A study to find out how long people with melanoma should have treatment with pembrolizumab and nivolumab (DANTE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Melanoma
Secondary cancers
Status:
Closed
Phase:
Phase 3
This study is for people with melanoma that has spread to other parts of the body (metastatic).
More about this trial
Melanoma skin cancer can sometimes spread to other parts of the body. This is called metastatic melanoma.
A possible treatment for metastatic melanoma is immunotherapy. It helps the body’s natural defence system (the immune system 
) to find and destroy the cancer. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are 2 possible immunotherapy treatments.
) to find and destroy the cancer. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are 2 possible immunotherapy treatments. The current treatment is to have pembrolizumab or nivolumab for up to 2 years, or for as long if it is helping you. But doctors are unsure about how long people should have treatment for.
Doctors think that pembrolizumab and nivolumab work best during the first year of treatment. So they would like to know if they can stop the treatment after a year. This could lower the risk of side effects and the number of times people have to visit the hospital.
This study is in 2 parts. The 1st part, called registration, is to find people who may be willing to join the main part of this study. The 2nd part is the study itself. Everyone joining the 2nd part of this study will have one of the following:
- stop pembrolizumab or nivolumab after 1 year of treatment
- continue pembrolizumab or nivolumab for as long as doctors think it is still effective, the side effects aren’t too bad or for up to 2 years or for longer than 2 years
The main aim of this trial is to find out whether stopping pembrolizumab or nivolumab after a year is just as good as having it for longer. They also want to find out whether having treatment for a year can:
- reduce the number of side effects
- improve the
quality of life of people with melanoma
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 the 1st part of this study (registration) if all of the following apply. You:
- have melanoma that has spread to the nearby
lymph nodes or to other parts of the body (stage 3 or stage 4) and cannot be completely removed with surgery - are going to have, or are having, pembrolizumab or nivolumab for the 1st time OR have started pembrolizumab or nivolumab on its own or nivolumab with ipilimumab less than a year ago
- are at least 18 years old
You may join the 2nd part of this study if all of the following apply:
- you joined the 1st part of this study (registration)
- your cancer stayed the same or got better after 12 months of pembrolizumab or nivolumab
- you have had pembrolizumab or nivolumab for at least a year
- you are well enough to continue treatment with nivolumab or pembrolizumab
- you are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- you are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility that you or your partner could become pregnant
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
You:
- have had treatment that reached your whole body (systemic) for melanoma that has spread, unless it was given in addition to the main treatment such as surgery and you have finished it more than 6 months before the start of pembrolizumab or nivolumab
- have cancer spread in the brain and it is getting worse (progression) or you are taking high doses of corticosteroids such as prednisolone to help with the symptoms
- have had another cancer in the past 5 years apart from stage 1 or stage 2 non melanoma skin cancer, a
carcinoma in situ that has been successfully treated or any other cancer that has been successfully treated and there has been no sign of it for more than a year
Medical conditions
You:
- have active HIV
- have active hepatitis B or hepatitis C
- have an active infection that needs treatment that reaches your whole body (systemic)
- have a severe
auto immune disease or inflammation of the lung tissue (pneumonitis ) - have any other severe condition that the trial team think could affect you taking part
- are pregnant or breastfeeding
Trial design
This is a phase 3 study. Researchers hope that around 1,208 people from the UK will agree to take part.
This study is in 2 parts:
- registration
- the study itself (randomisation)
Registration
Doctors want to find people who:
- are about to start pembrolizumab or nivolumab
- have been having pembrolizumab or nivolumab for up to 12 months
During this part of the study, you have treatment as normal. You have pembrolizumab or nivolumab as a drip into your bloodstream (intravenously) every 2, 3 or 4 weeks.
After 12 months of treatment, your doctor asks you whether you want to join the 2nd part of this study. You don’t have to join the 2nd part if you don’t want to.
Your doctor might ask for a sample of your cancer (archival tumour sample) taken when you were diagnosed.
They may also ask if a specialist researcher can interview you. They want to know your opinion about this study and your reasons for choosing to take part.
You don’t have to agree to give the archival tumour sample or to have the interview if you don’t want to. You can still take part in this study.
Randomisation
The 2nd part of this study is the randomisation. Everyone is put into 1 of the following treatment groups by computer:
- stop pembrolizumab or nivolumab (experimental group)
- continue pembrolizumab or nivolumab for as long as doctors think it is still effective, the side effects aren’t too bad or for up to 2 years or for longer than 2 years (treatment group)
Neither you nor your doctor will be able to decide which group you are in.
If you join the experimental group and your cancer starts to grow again, you will talk with your doctor about restarting treatment with pembrolizumab or nivolumab, or other treatments that are available.
Everyone taking part completes a questionnaire:
- before finding out which group they go to
- then every 3 months for up to 18 months
The questionnaires ask about how symptoms of cancer and side effects of treatment affect your quality of life.
Hospital visits
You see a doctor and have some tests before taking part. The tests might include:
During treatment, you go to hospital and see the study team every 2 to 6 weeks. This is the same as the standard treatment.
After treatment, you see the study team every 3 months, for the first year. You then see them every 6 months for 3 years.
You have CT scans or MRI scans regularly during treatment and afterwards. This is the same as the standard treatment. You have a CT scan or MRI scan:
- every 3 months for the first year
- then every 6 months for 3 years
Side effects
The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.
Pembrolizumab and nivolumab affect the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. Side effects can happen during treatment or some months after treatment has finished.
The most common side effects of pembrolizumab and nivolumab are:
- skin rash, itchy skin and changes to your skin colour
- fatigue (tiredness)
- loss of appetite
- shortness of breath and cough
- pain in your joints and back
- high temperature (fever)
- swelling in the legs and feet
- low levels of salt in your body that can cause muscle cramps and confusion
- feeling or being sick
- diarrhoea or constipation
- a drop in the number of red blood cells causing breathlessness and looking pale
We have more information about the possible side effects of pembrolizumab and nivolumab.
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 Sarah Danson
Supported by
Sheffield Teaching Hospitals NHS Foundation Trust
The University of Sheffield
Leeds Institute of Clinical Trials Research
University of Leed
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
15706
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
