A trial looking at ACVA for cancers that test positive for carcinoembryonic antigen (CEA) (PH1/099)

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 1

This trial looked at a treatment called ACVA (anti CEA vaccine) for people who have cancer that makes a protein called CEA. This trial was supported by Cancer Research UK.

ACVA is a type of biological therapy known as a DNA vaccine. ACVA is made from the tetanus vaccine, but researchers have added some new genetic material (DNA) to modify it. Because the genetic material has been changed, it can also be classed as a type of gene therapy.

CEA stands for carcinoembryonic antigen. It is a marker (protein) made by some types of cancer. The research team hoped that ACVA would help the immune system to recognise cancer cells that make CEA, and kill them.

The aims of the trial were to find out

If ACVA can help the immune system recognise and kill cancer cells that make CEA
What the side effects are

Summary of results

The research team found that ACVA was safe to use and that it did cause an immune response Open a glossary item in this group of patients.

This trial recruited 27 adults into 1 of 2 groups. There were

15 people with advanced cancer that had spread
12 people who had already had anti cancer treatment and had no signs of cancer

The people taking part had a number of different cancers that made CEA. Most people who took part had either bowel cancer or lung cancer. The people who had no signs of cancer had been treated successfully, but had an increased risk of their cancer coming back.

Everyone taking part had ACVA injections into a muscle. They had between 3 and 6 injections over a number of weeks.

The research team did a number of different tests to see if ACVA affected the immune system. They found that in some people there was an increase in certain immune cells after treatment. This showed that ACVA did activate the immune system.

First they looked at the level of T cells produced by the immune system. They measured these cells in 2 different ways and found that in total they were raised in

3 out of 15 people (20%) who had advanced cancer
6 out of 12 people (50%) who’d already had successful treatment

They also looked at the level of an antibody produced by the immune system. They measured this in 3 different ways and found that in total it was raised in

8 out of 15 people (53%) who had advanced cancer
9 out of 12 people (75%) who’d already had successful treatment

The research team were able to look at how well the treatment worked for 13 out of the 15 people with advanced cancer. They found that the cancer stayed the same in 3 people, but continued to grow in 10 people. No one’s cancer got smaller.

The people taking part did have some side effects, but very few people had any serious side effects. The most common side effects were diarrhoea, tummy (abdominal) pain, tiredness (fatigue), cough and shortness of breath.

The research team concluded that ACVA was safe to use, and that it did stimulate the immune system of people with cancers that make CEA.

We have based this summary on information from the team who ran the trial. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item ) or published in a medical journal yet. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.