
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This trial is looking at sunitinib with nivolumab. It is for children, teenagers and adults whose soft tissue sarcoma or bone sarcoma has come back after treatment.
We use the term ‘you’ in this summary but if you are a parent we are referring to your child.
Doctors are looking for new ways to treat sarcomas. In this trial they are looking at sunitinib and nivolumab.
Sunitinib is a called a cancer growth blocker. It works by blocking substances that sarcoma cells need to grow and divide.
Nivolumab is a monoclonal antibody. It is an . It works by helping the
find and kill sarcoma cells.
In this trial you have both sunitinib and nivolumab.
The main aim of this trial is to find out how well this treatment works for soft tissue sarcoma and bone sarcoma that has come back after treatment.
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 you have one of the following sarcomas:
And all of the following apply.
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You have:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase1/2 trial.
There are 2 stages to this trial. The first stage has finished. In this stage the team found the best dose of sunitinib and nivolumab to give.
The second stage is now open. In this stage the team need a total of 160 people to take part with 10 people from the UK.
Everyone has sunitinib and nivolumab. You start taking sunitinib first. Then 2 weeks later you start having nivolumab.
Sunitinib is a capsule. You take it once a day. Your doctor tells you how many to take each day. You can take it with or without food. You have a diary to fill in when you take your capsules and how many. You bring this diary with you when you go to the hospital.
You have nivolumab as a drip into a vein. You have it every 2 weeks.
You continue having sunitinib and nivolumab for as long as the treatment is working and the side effects aren’t too bad.
Samples for research
The team ask for a sample of tissue (biopsy) from the sample when you were first diagnosed and then:
You must agree to have these samples taken to take part.
They might also ask for another biopsy if the one taken at 3 months shows your sarcoma hasn’t changed. They can take the sample when the drug is considered to be no longer working or is considered to be working, whichever comes first. You don’t have to agree to have this sample taken.
The team also take extra blood samples during the trial. Where possible they will take these when you have you have your routine blood tests.
Researchers use these samples to:
You see the doctor to have tests before taking part. These tests include:
You see the doctor regularly during treatment to see how you are and for blood tests.
You have a CT or MRI scan every 8 weeks till the end of treatment and a heart scan every 12 weeks. You have a heart trace every:
At the end of treatment you see the doctor for the same tests you had at the start.
You then see them every 3 months.
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. |
The most common side effects of nivolumab are:
The most common side effects of sunitinib are:
We have more information about:
Your doctor or a member of the trial team will talk to you about the side effects before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Sandra Strauss
University College London Hospitals NHS Foundation Trust
Grupo Español de Investigación en Sarcomas (GEIS)
The Jon Moulton Charity Trust
Pfizer
Bristol-Myers Squib
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.