A trial of TG01 with GM-CSF and gemcitabine for people who have had surgery to remove cancer of the pancreas

Cancer type:

Pancreatic cancer

Status:

Results

Phase:

Phase 1/2

This trial looked at a vaccine called TG01 with GM-CSF and gemcitabine for cancer of the pancreas. This trial was for people who had surgery to completely remove their pancreatic cancer.

It was open for people to join between 2013 and 2016. The team presented the results at a conference in 2017 and published the results in 2020.

More about this trial

After surgery you may have the chemotherapy drug gemcitabine. This is to reduce the chances of your cancer coming back. It can help, but researchers are always looking for better treatments.

In this trial they looked at a vaccine called TG01. It is a type of immunotherapy Open a glossary item . This means it uses your own immune system to kill cancer cells.

In this trial everyone also had GM-CSF. GM-CSF Open a glossary item is a growth factor that doctors sometimes use to increase the number of white blood cells in the body. The researchers thought it would help TG01 to work better.

The aims of this trial were to find out:

about the side effects of TG01, GM-CSF and gemcitabine
if this treatment can delay or reduce the chances of your cancer coming back
what the immune response is after having TG01, GM-CSF and gemcitabine together

Summary of results

The trial team found that:

the immune system responded well to TG01 with GM-CSF
the combination of TG01, GM-CSF and gemcitabine was well tolerated

About this trial
This was a phase 1/2 trial. 32 people took part. After the first 19 people the team changed the dosing of the TG01 vaccine.

Everyone taking part started the TG01 and GM-CSF as soon as possible after surgery to remove their pancreatic cancer. They had TG01 and GM-CSF:

when they were having the gemcitabine
every month for a year after finishing gemcitabine and then
every 3 months for another year

Results

Side effects
There were 10 very serious side effects reported. Gemcitabine caused 6 of these side effects.

The serious side effects included:

a drop in red blood cells (anaemia )
lung infection
blood clot on the lung
a mini stroke (TIA)
2 people who had a high temperature (fever)

TG01 caused 3 of the serious side effects. All were allergic reactions. Of which 2 were very serious reactions (anaphylaxis).

The treatment for the allergic reaction was steroid tablets and antihistamine Open a glossary item tablets. This worked within 1 to 2 hours. As the trial continued the team decided to give steroids and antihistamine tablets to everyone while having TG01 as a preventative to a possible allergic reaction.

The other serious side effect was shortness of breath. This was possibly caused by all the treatments.

Other side effects of TG01 included:

reaction at the site of injection such as redness, itching and swelling
tiredness
pain
flu-like symptoms

Response of the immune system
The team used 2 different tests to find out how the immune system responded to TG01 and GM-CSF.

The first test was the delayed-type hypersensitivity (DETH) test. You have TG01 as an injection under the skin. The team looked at the injection site 2 days later to see if there was any redness or a lump. They measured the reaction and if it was at least 5 mm across it meant the immune system had responded. They did the DETH test at least 9 times on everyone.

The second test used blood samples. Everyone gave blood:

before treatment
twice during treatment and
at the end of the trial

In the lab the team looked for T cells in the samples. T cells are a type of white blood of the immune system. They help fight infections and cancer.

Particular T cells are made in response to vaccines such as TG01. The team looked for these T cells. They then divided this number of T cells with the number of T cells that weren’t made due to the vaccine. They considered the immune system had responded if there were at least twice as many of the particular T cells due to TG01.

The team confirmed there was an immune response if either or both tests showed a reaction at least once. Of the 32 people, 30 people’s immune system responded.

How well TG01 worked
The median Open a glossary item length of time people survived was just under 33 ½ months (33.3). The median length of time people lived and had no sign of cancer was just over 16 months (16.1).

Each year for 3 years after treatment the team looked at the number of people who were still living. They found it was:

30 people at 1 year
23 people at 2 years
12 people at 3 years

The team looked at other trials that used chemotherapy only. They found that the length of time people survived was similar. They said that this might suggest TG01 with GM-CSF and chemotherapy could have a combined effect.

Conclusion
The trial team concluded that:

the response of the immune system to TG01 with GM-CSF is suitable
the side effects in combination with gemcitabine are acceptable
they have identified a dosing schedule for the TG01 vaccine

Other clinical trials have shown that combination chemotherapy after surgery increases the length of time people live with pancreatic cancer. But as their cancer still comes back there is a need for further treatment choices. Based on the results of this trial the team suggest that the TG01 vaccine might be very useful in this situation.

Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.