A trial comparing nivolumab with everolimus for advanced kidney cancer (CA209025)

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Cancer type:

Kidney cancer
Renal cell carcinoma




Phase 3

This trial compared nivolumab (BMS-936558) with everolimus to treat cancer that had grown outside the kidneys or had spread to another part of the body.  It was for people with the most common type of kidney cancer called renal cell cancer. 

More about this trial

Doctors often treat advanced kidney cancer with biological therapies that block blood vessel growth to cancer cells. These are called anti angiogenic drugs. If your cancer had stopped responding to these drugs, you may have another drug called everolimus.

In this trial, researchers looked at a new drug called nivolumab. It is another type of biological therapy called a monoclonal antibody.

The aim of the trial was to see if nivolumab worked better than everolimus for advanced renal cell cancer in people who already had other anti angiogenic drugs.

Summary of results

The trial team found nivolumab was better than everolimus for people with advanced renal cell cancer. 

This was an international phase 3 trial. It was a randomised trial. 821 people were put into 1 of 2 treatment groups

  • 410 had nivolumab
  • 411 had everolimus

CA209025 trial - Randomisation diagram

The team looked at how well the 2 treatments worked.

For those who had nivolumab

  • in 4 people their cancer had completely gone (complete response Open a glossary item)
  • in 99 people their cancer had shrunk (partial response Open a glossary item)

For those who had everolimus

  • 2 people had a complete response
  • 20 people had a partial response

The trial team looked at the number of people who had died. They found that 

  • in the nivolumab group it was 183
  • in the everolimus group it was 215

Overall the average length of time people lived was

  • 25 months for those who had nivolumab
  • just over 19½ months for those who had everolimus

CA209025 trial - barchart diagram

79 out of every 100 people (79%) who had nivolumab had side effects.

88 out of every 100 people (88%) who had everolimus had side effects.

The most common side effects of nivolumab were

  • tiredness
  • feeling sick
  • itching

The most common side effects of everolimus were

  • tiredness
  • feeling sick
  • sore mouth
  • a drop in red blood cells

People were asked questions about how their cancer and any treatment affected their day to day life. This called quality of life Open a glossary item.

At the start of the trial the average score for quality of life was the same in each group.

During the trial the average score for those having nivolumab increased. This means that people rated their ability to manage day to day living as better than those having everolimuis. And they reported coping with their treatment more easily.

At the end of the trial there was a considerable difference in the quality of life score between the 2 groups.

The team concluded that for people with advanced renal cancer who have already had other anti angiogenic drugs there is benefit in having nivolumab. 

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.

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

Prof Martin Gore

Supported by

Bristol-Myers Squibb
NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:


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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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