The researchers found that that nivolumab (either on its own or with ipilimumab), improved treatment compared with ipilimumab alone.
These results were first published in 2015. The researchers looked at the results again in 2019.
About this trial
This was an international trial with 945 people taking part in a number of different countries. Everybody had melanoma that couldn’t be removed with surgery or that had spread to another part of their body. They hadn’t had any other drug treatment for advanced melanoma.
It was a
randomised trial. The people taking part were put into 1 of 3 treatment groups by computer. Neither they nor their doctors could choose which group they were in.
- 315 had ipilimumab
- 316 had nivolumab
- 345 had nivolumab and ipilimumab
Results
The researchers looked at the average length of time people lived without any signs of their melanoma getting worse. They found it was:
- just under 3 months (2.9 months) in the group who had ipilimumab
- just under 7 months (6.9 months) in the group who had nivolumab
- 11 ½ months in the group who had nivolumab and ipilimumab
At 5 years, the researchers looked at how long people lived. This is called overall survival. This was:
- just under 3 out of 10 people (26%) who had ipilimumab
- just over 4 out of 10 people (44%) who had nivolumab
- just over 5 out of 10 people (52%) who had nivolumab and ipilimumab
Quality of life
Everyone filled out a questionnaire before starting treatment and at set times during treatment. The questionnaire asked about side effects and how they had been feeling. This is called a
quality of life study.
The trial team found that people having both immunotherapy drugs or nivolumab alone didn’t report a worse quality of life compared with those who had only ipilimumab.
Side effects
Many of the patients in all 3 groups had some side effects during treatment, but the number of serious side effects was higher in the group who had both nivolumab and ipilimumab. The most common side effects they had were:
- diarrhoea
- tiredness (fatigue)
- a rash
- liver damage
Conclusion
The trial team concluded that having nivolumab alone or in combination with ipilimumab worked better than having ipilimumab alone in people with advanced melanoma.
Where this information comes from
We have based this summary on information from the research team. The information has been reviewed by independent specialists (
peer reviewed 
) and published in a medical journal. The figures we quote above were provided by the trial who did the research. We have not analysed the data ourselves.