TeloVac trial for pancreatic cancer

I have read about a trial using a vaccine, called GV1001, for pancreatic cancer. Can you tell me more about this?

On this page there is information about

What GV1001 is
Who can take part in this trial
What the trial will involve

How you have GV1001 vaccine
Side effects of GV1001
How to find out more about the trial

GV1001 is a vaccine treatment that is being tested in clinical trials. The GV1001 vaccine for pancreatic cancer is new and experimental, so it is only available as part of a clinical trial. It has shown some promise as a treatment for pancreatic cancer in earlier trials.

A phase 3 trial has recently started to recruit in the UK. The name of this trial is ‘TeloVac’. It will recruit 1,110 people who have advanced pancreatic cancer and cannot have surgery because their cancer may have spread locally (to an area near to the pancreas) or to elsewhere in the body. This trial will be eventually recruiting in about 60 hospitals in the UK. Please note that it is unlikely that GV1001 will cure people of their pancreatic cancer. This trial aims to find out if adding GV1001 to combination chemotherapy treatment with gemcitabine and capecitabine will help people with advanced pancreatic cancer to live for longer. The researchers will also look at the side effects to find out how treatment affects their quality of life.

There are 3 treatment groups in this trial and the trial is randomised. The people taking part are put into the different treatment groups by a computer. Neither the patient nor their doctor will be able to decide which group they are in.

People in group 1 will have gemcitabine and capecitabine together over a total of 8 weeks. This is widely used treatment for advanced pancreatic cancer.

People in group 2 will have gemcitabine and capecitabine together, over a period of 8 weeks (the same chemotherapy as group 1). They will then begin a course of GV1001 vaccine injections.

People in group 3 will have the same gemcitabine and capecitabine treatment as groups 1 and 2. But they will start their course of GV1001 vaccine from the first week of chemotherapy. Whichever group you are in, you will need to visit hospital nearly every week.

You have GV1001 as an injection under the skin into the lower part of your tummy (abdomen). You will also have an injection of growth factor, called GM-CSF, about 15 minutes before the GV1001 and into the same area. This is also an injection under the skin. The growth factor boosts the number of white blood cells in the body, which the researchers think will improve the way the vaccine works.