A trial of nivolumab with or without ipilimumab after surgery for kidney cancer (CheckMate 914)
Cancer type:
Status:
Phase:
This trial looked at the immunotherapy drugs ipilimumab with nivolumab or nivolumab on its own for kidney cancer.
It was for people having surgery for a type of kidney cancer called renal cell cancer. And who had a high risk of the cancer coming back.
The trial was open for people to join between 2017 and 2022. The team published results of part A in 2023.
More about this trial
Doctors treat kidney cancer using surgery to remove the whole kidney or part of it. But some people have a higher risk of the cancer coming back. So, researchers are looking at treatment after surgery to try and reduce the risk of this happening.
In this trial, they looked at 2 drugs called nivolumab and ipilimumab.
Nivolumab and ipilimumab are both types of immunotherapy. They work in slightly different ways. They help the body’s 
to find and kill cancer cells.
There were two parts of this trial, part A and part B. Everyone taking part had surgery.
In part A, everyone had their surgery then either:
- ipilimumab and nivolumab or
- 2 dummy drugs (
placebos )
In part B, everyone had their surgery then 1 of the following:
- nivolumab and ipilimumab
- 2 dummy drugs
- nivolumab and a dummy drug
The aims of the trial were to find out:
- how well treatment worked to stop or delay the cancer coming back
- about the side effects of treatment
- how treatment affects
quality of life
The results in the summary below are about part A. We will add the results of part B when they are available.
Summary of results
Part A of this trial showed that ipilimumab and nivolumab did not work better than dummy drugs () for people with renal cell cancer at high risk of it coming back after surgery.
Trial design
This was an international phase 3 trial.
816 people joined part A and were put into treatment groups at random:
- 405 people in the ipilimumab and nivolumab group
- 411 people in the dummy drug (placebo group)
1 person in the ipilimumab and nivolumab group didn’t start treatment. And 4 people in the dummy drug group didn’t start treatment.
Everyone had treatment for up to 6 months, as long as it was working, and the side effects weren’t too bad.
- 231 people completed treatment in the ipilimumab and nivolumab group
- 361 people completed treatment in the dummy drug group
When these results were published no one in either group was still having treatment.
The research team looked at how long it was between treatment and signs that the cancer had come back. This is called disease free survival.
The researchers looked at when the cancer had come back in half the people, or they had died, in each group.
For people in the dummy drug group this was about 50.7 months.
For people in the nivolumab and ipilimumab group the researchers were not able to find this out. This is because more than half the group were still living with no signs of cancer when the researchers ended their follow up.
Around 7 out of 10 people were living and had no signs of cancer at 2 years in both the nivolumab and ipilimumab group (76%) and the dummy drug (74%) group.
- 359 out of 404 people (89%) having nivolumab and ipilimumab
- 231 out of 407 people (57%) having the dummy drugs
Most of these were mild or didn’t last long.
The most common side effects in people having ipilimumab and nivolumab were:
- itchy skin (pruritis)
- tiredness (fatigue)
- skin rash
- diarrhoea
- changes to
thyroid hormone levels
Some people had more serious side effects. This was:
- 115 out of 404 people (28%) having nivolumab and ipilimumab
- 8 out of 407 people (2%) having the dummy drugs
People who had ipilimumab and nivolumab had more severe side effects. These included:
- diarrhoea
- changes to
liver function tests - problems with the
adrenal glands making hormones
The trial team looked at how many people stopped having treatment due to side effects. This was:
- 117 out of 404 people (29%) having nivolumab and ipilimumab
- 4 out of 407 (1%) people having treatment with dummy drugs
Some of the side effects were more serious and 4 people died due to side effects from ipilimumab and nivolumab. No one died due to treatment with the dummy drugs.
Part A of this trial showed that ipilimumab and nivolumab isn’t useful for people with a high risk of renal cell cancer coming back after surgery. But these results still add to our knowledge and understanding of cancer and how to treat it.
We are waiting for the results of part B of the trial.
Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.
Summary of Research: Adjuvant Nivolumab Plus Ipilimumab Versus Placebo for Localized Renal Cell Carcinoma After Nephrectomy (CheckMate 914): A Double-Blind, Randomized, Phase 3 Trial
R Motzer and others
Targeted Oncology, 2023. Volume 18, issue 5, pages 639-641.
Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial
R Motzer and others
The Lancet, 2023. Volume 401, issue 10379, pages 821-832.
) and published in medical journals. 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.
Chief Investigator
Dr Thomas Waddell
Supported by
Bristol-Myers Squibb
Ono Pharmacutical
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
