A trial of nivolumab after surgery for urothelial cancer (CA209-274; CheckMate 274)
Cancer type:
Status:
Phase:
This trial looked at nivolumab after surgery for people with high risk muscle invasive urothelial cancer.
High risk cancer means there is an increased risk that it will come back after surgery.
Muscle invasive cancer means that it has grown through the muscle wall of the bladder. But not into the muscles around the pelvis or tummy (abdominal wall), or spread to the 
.
Urothelial cancer is also called urinary tract cancer. It includes cancer of the:
- centre of the kidney (renal pelvis)
- tube that takes urine from the kidney to the bladder (ureter)
- bladder
- tube that drains urine from the bladder and out of the body (urethra)
This trial was open for people to join between 2016 and 2020. The team have published results in several medical journals between 2021 to 2024. They plan to publish more results in the future.
More about this trial
Doctors usually treat urothelial cancer with surgery. Some people also have a chemotherapy drug called cisplatin before or after surgery. This is for people who have a higher risk of their cancer coming back.
This trial was for people who were not able to, or didn’t want to, have cisplatin after their operation.
Doctors wanted to find out how well nivolumab works for this group of people.
Nivolumab is a type of immunotherapy. It helps the immune system kill cancer cells.
Everyone taking part had a test on their cancer cells to check for a protein called PD-L1. This stops the immune system working properly and attacking cancer cells. Nivolumab works by blocking PD-L1.
The trial team wanted to find out if having PD-L1 on cancer cells affects how well nivolumab works. They compared results for those who were:
- PD-L1 positive, meaning they had PD-L1 on at least 1 in 100 (1%) of their cancer cells
- PD-L1 negative, meaning they had PD-L1 on less than 1% of their cancer cells
About half the people taking part had nivolumab. And half had a dummy drug (placebo). Around 4 out of 10 people (40%) in each group were PD-L1 positive.
The main aims of the trial were to find out:
- how well nivolumab works
- more about the side effects
Summary of results
A total of 709 people from 29 different countries took part in this phase 3 trial. The people taking part were put into 1 of 2 treatment groups at random. Neither they nor their doctor could decide which group they were in.
There were:
- 353 people in the nivolumab group
- 356 people in the placebo group
In June 2021 the trial team published some early results. More than 8 out of 10 people (84%) were still having nivolumab or the placebo at the time.
These early results showed that nivolumab was working better than the placebo.
In 2024 they published more results. The trial team looked at how long it was before people's cancer started to grow.
They found it was:
- 22 months for those who had nivolumab
- 11 months for those who had the placebo
When they looked in more detail at just those whose cancer was PD-L1 positive, they found it was about:
- 53 months for those who had nivolumab
- 8 months for those who had the placebo
In 2024 the trial team also looked at how many were living 3 years after they joined the trial. They found it was:
- more than 6 out of 10 people (66%) who had nivolumab
- just under 6 out of 10 people (58%) who had the placebo
They also looked at how many people who were PD-L1 positive were living 3 years after they joined the trial. They found it was:
- more than 7 out of 10 people (71%) who had nivolumab
- less 6 out of 10 people (57%) who had the placebo
Side effects
Some people in each group had side effects. This was:
- just under 8 out of 10 people (79%) who had nivolumab
- less than 6 out of 10 people (56%) who had the placebo
The most common side effects for both groups included:
- itching
- severe tiredness (fatigue)
- diarrhoea
- rash
More people who had nivolumab had each of these side effects.
Some people had more severe side effects. This was:
- just under 2 out of 10 people (18%) in the nivolumab group
- less than 1 out of 10 people (7%) in the placebo group
These more severe side effects included high levels of proteins () called lipase and amylase. This can be a sign that there are problems with the . Most people didn’t have any symptoms caused by this.
The number of people who stopped their treatment because of side effects was:
- more than 1 out of 10 people (14%) in the nivolumab group
- less than 1 out of 10 people (2%) in the placebo group
We have more information about the side effects of nivolumab in our Cancer drugs section.
Quality of life
The trial team asked everyone to complete questionnaires before, during and after treatment. The questionnaires asked about how cancer and the treatment had affected their .
The team found that there was little difference in people’s quality of life between the 2 groups.
Conclusion
This trial team concluded that nivolumab after surgery can help stop urothelial cancer coming back. This is for people who have muscle invasive cancer and a increased risk that it will come back.
The team suggest that nivolumab after surgery should be for this group of patients.
These are early (interim) results. The trial team continue to follow up the people who took part and will publish more results in the future. We hope to update this page when more results are available.
More detailed information
There is more information about this research in the references below.
Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.
Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma
D F Bajourn and others
The New England Journal of Medicine, June 2021. Volume 384, number 22, pages 2102 to 2114.
Extended follow-up results from the CheckMate 274 trial
M D Galsky and others
Journal of Clinical Oncology, February 2023. Volume 41, number 6.
Extended Follow-up from CheckMate 274 Including the First Report of Overall Survival Outcomes
EAU Annual Meeting, 2024
UroToday.com website
Accessed December 2024
Where this information comes from
We have based this summary on the information in the articles above. Some of the information has been reviewed by independent specialists () and published in medical journals. Some of the information may not have been. We have not analysed the data ourselves. As far as we are aware, the links we list above are active and the articles are free and available to view.
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
Professor Robert Huddart
Supported by
Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
