A trial looking at a vaccine called GV1001 for pancreatic cancer that has spread (TeloVac)

Who can enter

You can enter this trial if you

• Have cancer of the pancreas
• Have pancreatic cancer that has spread and so cannot be removed by surgery or your pancreatic cancer has come back (recurred) after you had an operation to remove it
• Have pancreatic cancer that can be measured on a CT scan
• Have satisfactory blood test results
• Are well enough to take part (performance status 0, 1 or 2)
• Are willing to use 2 types of effective contraception if there is any chance that you or your partner could become pregnant
• Are over 18 years old

You cannot enter this trial if you

• Have pancreatic cancer that has spread to your brain or the tissues that surround it (the ‘meninges’)
• Have had chemotherapy in the last 12 months
• Have had radiotherapy within 4 weeks of the start of the trial treatment
• Have had any other cancer in the last 5 years except successfully treated carcinoma in situ of the cervix or basal cell carcinoma
• Are allergic to any of the drugs used in this trial
• Are on long term steroids, or other treatment that lowers your resistance to infection (if you are taking a short course of steroids to control your symptoms you may still be able to take part). Please note: you must never stop steroid treatment without talking to your doctor first
• Have any condition where your body cannot properly use the food you eat (‘malabsorption syndromes’)
• Have chest pain (angina) that is not controlled
• Have any other serious illness that may affect the results of the trial
• Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit 1,110 people in total. It is a randomised controlled trial with 3 groups. The people taking part are put into the treatment groups by a computer. Neither you nor your doctor will be able to decide what group you are in.

All groups will have gemcitabine chemotherapy once a week for 3 weeks, followed by a week’s rest. You have this treatment through a drip into a vein. At the same time you will take capecitabine tablets twice a day for 3 weeks, followed by a week’s rest. This is a 4 week cycle of chemotherapy.

If you are in group 1 you will repeat this 4 week cycle of chemotherapy until your treatment needs to change. This is the standard, or ‘control’ group.

If you are in group 2 you will repeat the 4 week cycle of chemotherapy twice. The week after this, you will start a course of the GV1001 vaccine. You will have the vaccination as a small injection under the skin on your tummy. Before each vaccine injection, you will have another small injection of a drug called GM CSF. This is to prepare your body for the vaccine. You will have these 2 injections 3 times a week for the first week, and once a week for the next 3 weeks. You will then have a week’s rest and another 2 injections. After this, you will have the injections once a month until your doctor no longer thinks that it is working.

If you are in group 3 you will repeat the 4 week cycle of chemotherapy until your doctor no longer thinks that it is working. You will have the GV1001 injections in the same way as group 2, but they will start at the beginning of your course of chemotherapy.

After each GV1001 injection, you will stay at the hospital for an hour. This is in case you have any reaction to the injection.

You will be asked to fill out a questionnaire. This will be before you start treatment, 2 months after your treatment starts and then every 3 months while you are on the trial. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

The research team may also ask if you would be willing to have some extra tests. You do not have to have these tests unless you want to.

The first test is to see how your vaccinations are working. You will have a tiny injection on the other side of your tummy to the vaccine. The injection may leave a red mark on your skin. You will measure the size of this mark and record the results in a diary. You will repeat this test at the same time as your vaccination, on certain visits, until the researchers have all the information they need.

The other tests involve giving samples of blood and urine. These are to see how your immune system is responding to the treatment. And to be used in scientific studies looking at pancreatic cancer. Again, you have the choice whether or not you take part in these extra tests. They will not affect your trial treatment in any way.

Hospital visits

Before you start the trial you will see the doctor and have some tests. These tests include

• Blood tests
• Temperature, pulse, blood pressure and heart rate
• Heart trace (ECG)
• Urine test
• CT scan

You will have your gemcitabine chemotherapy and your GV1001 injection as an outpatient at the hospital. On the weeks that you do not have treatment, your research doctor or nurse may meet with you to check how things are going. So whichever group you are in, you will need to visit the hospital most weeks throughout the trial.

You will have another CT scan and blood test 2 months after you start the trial, and then 3 months after that. You will then continue to have CT scans every 3 months while you are on the trial.

You will also have blood tests and check ups throughout your treatment that are not part of the trial. Your doctor or chemotherapy nurse will be able to tell you more about this.

After you finish the trial, you will see the doctor for a check up and blood tests every 3 months.

Side effects

All chemotherapy drugs have some side effects. The most common side effects of the chemotherapy drugs in this trial are

• Tiredness (fatigue)
• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Feeling or being sick
• Diarrhoea
• Sore mouth
• Flu like symptoms
• Sore hands and feet (‘hand foot syndrome’)
• Chest pain (this is rare)

The most common side effects of the GV1001 vaccine and GM CSF injections are

• Mild pain or rash at your injection site
• Flu like symptoms (aches, pains and temperature) - taking paracetamol usually helps with this

There is more information about gemcitabine and capecitabine chemotherapy on CancerHelp UK.