
"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 looking at adding SCIB1 to pembrolizumab for melanoma.
It is for people whose melanoma has grown into surrounding tissues or spread elsewhere in the body. This is advanced melanoma.
Pembrolizumab is a usual treatment for advanced melanoma. It is an immunotherapy. But it doesn’t work for some people. Doctors think this is because their isn’t working well enough to attack the cancer cells.
Researchers are looking for ways to improve treatment. In this trial, they are looking at a new treatment called SCIB1.
SCIB1 is a cancer vaccine. It is a liquid that contains small pieces of from cancer cells. We know from previous research that SCIB1 might help activate cells in the immune system. This may help the cells of the immune system to recognise and destroy melanoma cells.
The main aims of this trial are to:
The following bullet points list 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.
Cancer related
You:
Medical conditions
You:
Other
You:
This is a phase 2 trial. The researchers need 44 people to take part..
You have:
You have SCIB1 as follows:
You have 2 SCIB1 injections which you have into different areas of your upper arm or the muscle in your thigh. 2 injections are 1 treatment of SCIB1.
A doctor or nurse gives the injections using a special handheld device. This injects the SCIB1 and then gives a short electrical impulse that lasts less than half a second.
You have pembrolizumab every 6 weeks. You have it as a drip into a vein.
You have treatment for up to 2 years as long as it is working and the side effects aren’t too bad.
The trial team ask you to fill out a questionnaire after each injection of SCIB1. This asks about your experience of having this type of injection.
You see a doctor and have some tests before you can take part. These include:
You also have a test to see if you have melanoma that makes certain proteins that your immune system can recognise. The trial team test a sample of tissue () you gave when you were first diagnosed.
You see the trial team for a check up 1 month after you finish treatment. If you do not have a regular visits to your doctor, a member of the trial team will call you every 3 months for up to a year to see how you are getting on.
You have a CT scan:
Having SCIB1 and pembrolizumab at the same time is a new treatment. So, there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you have a phone number to call if you are worried about anything.
Only a few people have had SCIB1. The possible side effects include:
When you have the injections, you will feel twitching in your muscle, which might feel painful. Your arm and leg will be sore to the touch afterwards.
Pembrolizumab affects the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.
If you have any of these side effects, you should tell the 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 pembrolizumab are:
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
We have more information about pembrolizumab.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Poulam Patel
Scancell Ltd
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.”