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

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.