A trial looking at tremelimumab for cancer of the food pipe (oesophagus) or stomach that has spread

Cancer type:

Oesophageal cancer

Stomach cancer

Status:

Results

Phase:

Phase 2

This trial looked at tremelimumab for advanced food pipe (oesophageal) and stomach (gastric) cancer. Tremelimumab is also called CP-675206, and used to be called ticilimumab.

Doctors usually treat food pipe and stomach cancer with surgery, chemotherapy or radiotherapy. But sometimes the cancer starts to grow again or spreads to another part of the body. When this happens it is often more difficult to treat.

Tremelimumab is a type of biological therapy called a monoclonal antibody. It works by triggering the body’s immune system to attack cancer cells. Doctors hoped it would be useful for cancer that had started to grow again.

The aims of this trial were to find out

What effect tremelimumab has on the body
More about the side effects
How well it works as a treatment for advanced stomach and food pipe cancer

Summary of results

The research team found that tremelimumab did affect the immune system. But that it didn’t work as well as they had hoped as a treatment for stomach and food pipe cancer.

This trial recruited 18 people with advanced cancer

6 people had stomach (gastric) cancer
6 people had cancer of the food pipe (oesophagus)
6 people had cancer of the area where the food pipe meets the stomach (called the oesophageal gastric junction, or OGJ).

They had all had cisplatin chemotherapy before, but their cancer had continued to grow.

They had tremelimumab into a vein once every 3 months. Each 3 month period is one cycle of treatment. 12 people taking part had 1 cycle, 5 people had 2 cycles, and 1 person had 11 cycles of treatment.

The research team looked at tumour markers Open a glossary item and found that the levels of CA19-9 and CEA went down for some patients but up for others. The people whose levels went down generally did better than those whose levels went up.

They also looked at how well the cancer responded to treatment. They found that

1 person’s cancer got smaller (doctors call this a partial response)
4 people’s cancer stopped growing (doctors call this stable disease)
13 people’s cancer continued to grow

The person whose cancer got smaller was still doing well when the results of this trial were published, 2 years and 8 months after they started treatment.

The side effects of tremelimumab were mostly mild, but 1 person unfortunately died after developing a hole in their bowel (bowel perforation). This is a known but very rare side effect of this particular type of monoclonal antibody.

The most common side effects were itching, a rash, tiredness (fatigue), diarrhoea and a drop in white blood cells called eosinophils.

The research team concluded that although the overall response wasn’t as good as they had hoped, the one very good response meant that tremelimumab should be looked at again in further trials.

We have based this summary on information from the team who ran the trial. 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. We have not analysed the data ourselves.