A trial of the IMA970A and CV8102 vaccine for liver cancer (HepaVac-101)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Liver cancer

Status:

Closed

Phase:

Phase 1/2

This trial is for people with very early, early or intermediate liver cancer that has not spread and who have had standard treatment.

More about this trial

The standard treatment for very early, early or intermediate stage liver cancer includes:

IMA970A is a vaccine. CV8102 and cyclophosphamide help IMA970A work better.

Researchers think this vaccine might help people with liver cancer. But first they need to find out if the vaccine:

is safe to give
triggers the immune system to act against the cancer

As a part of this trial you will have a single treatment with a chemotherapy drug called cyclophosphamide before having IMA970A and CV8102.

The main aims of this trial are to find out if this combination:

is safe and acceptable to give
can trigger the immune system

Who can enter

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:

have liver cancer that is very early stage, early stage or intermediate stage
have liver cancer that has the HLA type HLA-A*02 and, or HLA-A*24
have had a standard treatment for your cancer and there is no further active cancer needing treatment
have satisfactory blood test results
are fully active, more or less as you were before (performance status 0)
are willing to use reliable contraception during the trial and for 100 days after if you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

You have had:

anti cancer treatment that reaches the whole body (systemic treatment ) in the past 2 weeks
another cancer, or sign of cancer in the past 3 years apart from carcinoma in situ of the cervix, successfully treated non melanoma skin cancer

Medical conditions

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

are allergic to a certain type of antibiotic
have had a liver transplant
have or had an autoimmune disease such as rheumatoid arthritis, multiple sclerosis or SLE
are taking medication such as steroids that damp down your immune system apart from inhalers and creams
have HIV or another medical condition that affects your immune system
have an infection that is been treated with antibiotics
have fits (seizures) that isn’t controlled by medication
have fluid on the brain (encephalopathy)
have fluid on the abdomen (ascites) unless it is controlled by low doses of fluid tablets (diuretics) and you have no symptoms
have a problem with alcohol or drugs
have had a heart attack, severe or unstable angina, or heart surgery in the past 6 months
have had a stroke or blood clot (DVT) in the past 6 months
can’t have cyclophosphamide
have any other medical or mental health condition that the trial team or your doctor thinks could affect you taking part

Other

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

are taking part in another clinical trial
are allergic to the drugs used in this trial or any of their ingredients
are pregnant or breastfeeding

Trial design

This is a phase 1/2 trial. The trial team need about 40 people to join.

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 Open a glossary item

) 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.

Hospital visits

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

a physical examination
blood tests
heart trace (ECG )
CT scan or MRI scan

You see the doctor 3 days before starting the vaccinations. This is to have a blood sample and to have the cyclophosphamide.

During treatment you see the doctor before each vaccination to see how you are and for a blood test.

You have a CT scan or MRI scan about every 3 months.

You see the doctor 4 to 6 weeks after finishing treatment and have:

a physical examination
blood tests
heart trace (ECG)
CT scan or MRI scan

Side effects

Your doctor and nurse will monitor you closely for any side effects when you are having treatment.

IMA970A hasn’t been used in people before. So we don’t know what the side effects might be. Similar vaccines have been used in people and researchers think the side effects might be similar.

The most common side effect of these vaccines was a local reaction where the injection was given. These usually appeared soon after the injection and went back to normal. This included:

redness of the skin
swelling
itching
irritation
pain
increased sensitivity
hardening of the skin

About 2 or 3 people out of every 100 (2% to 3%) had a severe allergic reaction affecting the whole body. It usually happened within an hour of having the vaccines but might happen sometime after.

When you have IMA970A you stay in the hospital for at least 2 hours. This is to monitor you for an allergic reaction. And if this happens the nurses and doctor can treat you immediately.

CV8102 has been used in one clinical trial with healthy people. Side effects that were reported include: