A trial of sunitinib and nivolumab for sarcoma (ImmunoSarc2)

Cancer type:

Bone cancer
Children's cancers
Sarcoma
Soft tissue sarcoma

Status:

Open

Phase:

Phase 1/2

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. 
 

More about this trial

Doctors are looking for new ways to treat sarcomas. In this trial they are looking at sunitinib and nivolumab. 

Sunitinib is a targeted cancer drug Open a glossary item 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 immunotherapy Open a glossary item. It works by helping the immune system Open a glossary item 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. 

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 you have one of the following sarcomas:

  • a high grade (2 or 3) and dedifferentiated chondrosarcoma
  • extra skeletal myxoid chondrosarcoma
  • vascular sarcoma (including angiosarcoma, haemangioendothelioma and intimal sarcoma)
  • solitary fibrous tumour
  • soft tissue alveolar sarcoma
  • clear cell sarcoma 

And all of the following apply. 

  • Your sarcoma had spread to the nearby tissue or to another part of the body and could not be removed by surgery.
  • You have had treatment with an anthracycline Open a glossary item chemotherapy drug. And your sarcoma has come back in the last 6 months. You might be able to join if you have just been diagnosed with sarcoma that has spread and you can’t have an anthracycline drug. For some sarcomas you can join without having had treatment. Your doctor knows which ones these are.
  • You are willing to have tissue samples (biopsies Open a glossary item) of the sarcoma taken. 
  • You have an area of sarcoma that the doctor can measure. 
  • You can look after yourself but might not be able to do heavy physical work (performance status 0 or 1).
  • You have satisfactory blood test results.
  • You are willing to have a scan (ECHO  Open a glossary itemor MUGA Open a glossary item) that shows your heart works well enough to take part. Your doctor will arrange the scan and tell you the results. 
  • You agree to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant.
  • You are 12 to 80 years old.  

Who can’t take part

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

  • had 4 or more different courses of chemotherapy Open a glossary item treatment 
  • had another cancer in the past 5 years. This is apart from successfully treated non melanoma skin cancer Open a glossary item and in situ carcinoma Open a glossary item of the cervix. 
  • cancer spread to the brain or spinal cord unless there are no symptoms and it is controlled without the use of steroids 
  • had previous treatment with a PD-1, PD-L1, PD-L2 or CTLA-4 antibody. Your doctor will know if you have had one of these.
  • had an immunotherapy Open a glossary item treatment that caused moderate to severe side effect that has affected the immune system Open a glossary item for example inflammation of the liver, lungs or intestine. Your doctor will know more about this. 

Medical conditions

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

  • have an autoimmune disease Open a glossary item 
  • have a condition which requires you to take or you are taking medication such as steroids that affect how well your immune system works. Or if you have taken them within 2 weeks of starting treatment. This is apart from inhalers, creams or a small dose of steroids to replace what the body would make.  
  • had a heart problem Open a glossary item in the past year or you have a heart problem that isn’t controlled  
  • have hepatitis B or hepatitis C 
  • have a blocked blood vessel in your lung (pulmonary embolism) 
  • bruise or bleed easily. You have had a major or severe bleeding episode in the past 4 weeks. 
  • are taking medication such as warfarin to thin your blood. Unless you are using low weight heparin after having a blood clot in the leg or arm and there is no sign of any bleeding problems. 
  • have a problem with your thyroid gland Open a glossary item
  • have high blood pressure that isn’t controlled
  • have any other medical condition or mental health problem that could affect you taking part

Other

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

  • have a live vaccine Open a glossary item within the 30 days before joining the trial. The COVID-19 vaccine isn’t a live vaccine. 
  • are allergic to any of the drugs or any of their ingredients
  • are pregnant or breastfeeding
     

Trial design

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:

  • before you start treatment
  • at 3 months

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:

  • find out how well treatment is working
  • find out more about sarcoma
  • look for substances (biomarkers Open a glossary item) that might show how well treatment is working  

Hospital visits

You see the doctor to have tests before taking part. These tests include:

  • a physical examination Open a glossary item
  • blood tests
  • CT scan or an MRI scan
  • heart trace (ECG Open a glossary item)
  • heart scan (ECHO  Open a glossary itemor MUGA Open a glossary item)
  • bone scan – if sarcoma is in the bones or has spread to the bones

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:

  • 4 weeks from week 5 until 6 months of treatment
  • then every 8 weeks to the end of treatment

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. 

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.

 

The most common side effects of nivolumab are:

The most common side effects of sunitinib are:

  • tiredness (fatigue)
  • diarrhoea 
  • feeling or being sick
  • heartburn
  • changes to taste
  • high blood pressure
  • a drop in blood cells causing an increased risk of infection, bruising and bleeding
  • skin becoming yellow (possibly due to the colour of sunitinib)

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. 

Location

London

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 Sandra Strauss

Supported by

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 review date

CRUK internal database number:

17861

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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