You have 1 treatment of cyclophosphamide 3 days before starting the trial treatment. You have this as a
drip into a vein. It takes 20 to 30 minutes.
The trial treatment consists of both IMA970A and CV8102. You have a total of 9 vaccinations:
- one every 4 weeks
- then one every 3 weeks
You have 2 injections, IMA970A followed by CV8102. You have both as an injection into the skin (intradermal injection). You have a total of 5 to 6 injections at each visit.
You have both injections in the same area next to each other. You have them on the inside of your thigh or upper arm. The doctor will circle the area where you have the injections with a waterproof pen. So they can give all the injections in the same area.
After each vaccination you stay at the hospital for at least 2 hours. This is so the team can monitor you in case you have an allergic reaction.
This is the first time this vaccination has been used in people. A Data Safety Monitoring Board will review the safety of the vaccine at regular times. As a result of the Board’s review, the timing of when you have the vaccine might change.
Samples
Before joining the main trial, you must agree to have 2 blood samples taken.
The research team will use these samples to test for the HLA-A*02 and HLA-A*24 protein. As they think the vaccine will only work if your cancer has one of these proteins.
If your cancer has already been tested for the HLA proteins the team will ask your permission to get these results.
You cannot take part in the trial if your cancer doesn’t have either of these proteins. If this happens your doctor will talk to about the best treatment available to you.
The team also want to know if your immune system will respond to the vaccine. They will use some of these blood samples to find out. The outcome of this won’t affect you taking part in the trial.
If you have surgery before or during the trial to remove your liver cancer the team will ask for a piece of the cancer tissue. They will use this to look for substances in the tissue (
biomarkers 
) that might tell them how well the vaccine is working.
You don’t have to agree to having the tissue sample taken. You can still take part in the trial.