Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of ipilimumab after surgery for stage 3 melanoma (CA184029, EORTC 18071)
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
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 (
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
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
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 (
How to join a clinical trial
Professor Poulam Patel
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)