
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is looking at naxitamab with GM-CSF to treat that has continued to grow during treatment or has come back afterwards.
The trial is mainly for children and young people. We use the term 'you' in this summary, but if you are a parent, we are referring to your child.
Sometimes neuroblastoma comes back or treatment stops working. So doctors are looking for treatments to help this group of people.
In this trial they are looking at a new drug called naxitamab. It is an immunotherapy. It targets a protein on the surface of neuroblastoma cells called GD2. This helps the recognise and attack cancer cells.
In this trial everyone also gets . This is a drug called a growth factor. Doctors sometimes use it to increase the number of
in the body.
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
Neuroblastoma related
You cannot join this trial if any of these apply. You:
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 phase 2 trial is taking place worldwide. The team need to find up to 122 people including about 5 from the UK.
You have . Each 4 week period is a cycle of treatment. In each cycle you have:
You then have no more treatment until the next cycle begins.
You have naxitamab as a drip into a vein. It takes about 30 to 60 minutes each time. You will be at the hospital for longer than this.
You have GM-CSF as an injection under the skin. You have the first dose at the hospital and the rest of the injections at home. Your nurse will show you how to do this. They will give you written instructions and the equipment you need. They’ll ask you to fill in a diary to record the date and time you have the injections.
You have a scan and at 6 weeks after starting treatment. For people whose neuroblastoma has gone away completely or a little bit you have 5 more cycles of treatment every 4 weeks. You then have treatment every 8 weeks.
Everyone else continues to have treatment every 4 weeks. The trial team can let you know how long you have treatment for. This depends on your individual situation.
Samples for research
The researchers ask you to give some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
You need to give these samples to take part in the trial.
Quality of life
The trial team ask you to fill out a questionnaire:
The questionnaire asks about how you’ve been feeling. This is called a quality of life study.
You see a doctor and have some tests before you can take part in this trial. These include:
You might also have a PET scan.
You have naxitamab and the first dose of GM-CSF at the hospital on the day care ward.
You see the doctor for check ups and blood tests regularly during treatment.
Trial scans and bone marrow tests
You have a bone marrow test and trial scan after you started treatment. If the neuroblastoma has gone away completely or a little bit, you have these tests done again at 18 weeks after you started treatment. Everyone else has these tests done again at 14 weeks after starting treatment.
You have more scans and bone marrow tests during the trial to see how well treatment is working. The team can tell you more about when you have these.
Follow up
You see the trial team about 6 weeks after you finish treatment. After that you see them every 3 months for 3 years. You might see them at a routine hospital visit or they may call you to see how you are getting on.
Depending on how well treatment worked for you, you might have extra trial scans and bone marrow tests.
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.
Naxitamab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. 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 |
Naxitamab is a new drug. So there may be side effects we don’t know about yet.
The most common side effects of naxitamab we know about so far include:
The most common side effects of GM-CSF include:
The team will talk to you about all the possible side effects of treatment. You will have a chance to ask any questions you may have.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Juliet Gray
Y-mAbs Therapeutics
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”