A trial of nivolumab and ipilimumab for advanced kidney cancer (CheckMate 214)

Cancer type:

Kidney cancer

Renal cell cancer

Status:

Results

Phase:

Phase 3

This trial compared nivolumab and ipilimumab with a standard treatment called sunitinib for kidney cancer.

It was for people with a type of kidney cancer called renal cell cancer that had grown outside the kidney or spread to another part of the body.

More about this trial

Renal cell cancer can sometimes grow outside the kidney or spread to another part of the body. This is advanced kidney cancer.

Doctors can treat advanced renal cell cancer with targeted drugs. One targeted drug is called sunitinib. This is a standard treatment.

Doctors are looking for ways to improve treatment. In this trial, they looked at the combination of 2 drugs called nivolumab and ipilimumab.

Nivolumab and ipilimumab are both types of targeted drugs called immunotherapy. They work in slightly different ways. They help the body’s immune system to kill cancer cells.

The aims of the trial were to:

find out how well nivolumab and ipilimumab worked compared to sunitinib for renal cell cancer
learn more about the side effects
find out more about quality of life

Summary of results

The trial team found that nivolumab and ipilimumab worked better than sunitinib for some people with renal cell cancer.

The researchers published the results in 2018.

Treatment

This was a phase 3 trial. People were put into treatment groups at random.

1,096 people took part and:

550 had nivolumab and ipilimumab
546 had sunitinib

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The doctors looked at blood test results to help predict how well treatment might work and the chance the cancer might come back.

They found that:

422 people had a high chance
425 people had a medium chance
249 people had a low chance

The trial team were especially interested in how treatment worked for people in the medium to high risk groups.

Results

The researchers looked at how long people lived before the cancer started to grow again. This is called progression free survival. This was:

nearly 12 months in people who had ipilimumab and nivolumab
just over 8 months in people who had sunitinib

The results for these two groups do look different. But the researchers say it is more likely that the difference is due to chance. And not a difference in how well the treatments worked.

They also looked at how well the treatments worked in the medium to high risk groups.

In the nivolumab and ipilimumab group the cancer:

went away completely in 40 people
went away a little bit in 137 people
stayed the same in 133 people
got worse in 83 people

In the sunitinib group, the cancer:

went away completely in 5 people
went away a little bit in 107 people
stayed the same in 188 people
got worse in 72 people

The trial team followed everyone up for just over 2 years. They looked at the number of people living at 18 months. This is called overall survival. In the medium to high risk groups this was:

over 7 out of 10 people (75%) who had ipilimumab and nivolumab
6 out of 10 people (60%) who had sunitinib

In November 2017, the trial team decided that people in the sunitinib group could start having nivolumab and ipilimumab if their cancer got worse. This was because nivolumab and ipilimumab worked better.

Side effects

The trial team found that people who had sunitinib had more side effects overall compared with people who had nivolumab and ipilimumab. Although more people who had nivolumab and ipilimumab had to stop treatment early because of side effects.

People who had nivolumab and ipilimumab had more problems with itchy skin and skin rash.

People who had sunitinib had more problems with:

fatigue (tiredness)
diarrhoea
feeling or being sick

Quality of life

The trial team looked at how people rated their quality of life. People who had nivolumab and ipilimumab reported fewer symptoms and reported a better quality of life.

Conclusion

The trial team found that nivolumab and ipilimumab worked better than sunitinib for people with medium to high risk renal cell cancer.

Where these results come from
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.