A trial of ipilimumab after surgery for stage 3 melanoma (CA184029, EORTC 18071)

Cancer type:

Skin cancer




Phase 3

This trial looked at ipilimumab after surgery to remove melanoma.

More about this trial

Surgery is the usual treatment for melanoma. Having stage 3 melanoma increases the risk of it coming back. Doctors wanted to find out if having more treatment after surgery helps to reduce this risk.

In this trial, they looked at a drug called ipilimumab.

Ipilimumab is a type of biological therapy Open a glossary item called a monoclonal antibody Open a glossary item. Researchers thought that ipilimumab might help stop or delay melanoma coming back. But they didn’t know for sure so they wanted to find out more.

The aims of the trial were to:

  • find out if ipilimumab is a useful treatment after surgery
  • learn more about the side effects

Summary of results

The trial team found that ipilimumab lowered the chances of stage 3 melanoma coming back after surgery.

951 people took part in the trial. They were put into 1 of 2 treatment groups at random.

  • 475 had ipilimumab
  • 476 had a dummy drug (placebo Open a glossary item)

Neither the doctor nor the people who took part knew which group they were in. This is called a double blind trial.

The trial team followed everyone up for just under 3 years. They looked at whose melanoma had come back. They found this was

  • 234 people who had ipilimumab
  • 294 people who had the dummy drug

They also looked at how long it took for the cancer to start growing again. On average this was about:

  • 26 months in the people who had ipilimumab
  • 17 months in the people who had the dummy drug

CA184029 Trial Diagram

The most common serious side effects of ipilimumab were:

  • problems with the digestive system such as diarrhoea or feeling or being sick
  • raised enzyme levels in the liver
  • problems with the endocrine system for example an inflamed pituitary gland Open a glossary item

People with the more severe side effects had to stop treatment for a while before restarting again. And others had to stop treatment altogether. Just over 5 out of 10 people (52%) having ipilimumab had to stop treatment during the initial treatment period of 4 doses.

The trial team concluded that having ipilimumab after surgery was a very useful treatment for people with a high risk of their melanoma coming back. It significantly lowered the chances of the melanoma coming back but it did cause a lot of severe side effects.

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.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Poulam Patel

Supported by

Bristol-Myers Squibb
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 2675

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think