A trial of nivolumab for melanoma that can't be removed with surgery or has spread to other parts of the body (CheckMate 067)

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Cancer type:

Melanoma
Skin cancer

Status:

Results

Phase:

Phase 3

This trial was looking at a drug called nivolumab for melanoma that can’t be removed or has spread to another part of the body. If melanoma can’t be removed with surgery or has spread to another part of your body, it is called advanced melanoma.

Doctors can treat advanced melanoma with chemotherapy or a targeted drug. But researchers are looking for ways to improve treatment.

More about this trial

In this trial, researchers were looking at a drug called nivolumab and comparing it with another drug called ipilimumab as a first treatment Open a glossary item for advanced melanoma. Doctors already used ipilimumab to treat melanoma.
 
Nivolumab and ipilimumab are both immunotherapy drugs. They help the body’s immune system to attack melanoma cells.
 
In this trial, some people had nivolumab, some people had ipilimumab and some people had both drugs. The aims of the trial were to
  • See which treatment works best
  • Learn more about the side effects

Summary of results

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 Open a glossary item) 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.

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

Dr James Larkin

Supported by

Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

11156

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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