A trial of atezolizumab for bladder cancer (IMvigor210)

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Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Results

Phase:

Phase 2

This trial looked at atezolizumab for bladder cancer that has grown into surrounding tissue or spread to another part of the body.

More about this trial

This trial was for people who had a type of cancer called urothelial cancer. This is also known as transitional cell cancer or TCC. It can start in the:
  • bladder
  • kidneys
  • tubes that carry urine from each kidney to the bladder (ureters)
  • tube that carries urine from the bladder to the outside of the body (urethra)
Doctors can treat urothelial cancer that has grown into surrounding tissue or spread to another part of the body with chemotherapy. But they wanted to find out if atezolizumab could be a useful treatment for people in this situation.
 
Atezolizumab (MPDL3280A) is type of targeted cancer treatment called a monoclonal antibody. Doctors hoped it would help slow down or stop cancer growth.
 
PD-L1 is a protein which is found on cells of the immune system in some people with cancer. It helps protect cancer cells by hiding them from the immune system. Atezolizumab binds to PD-L1 to stop it working. This means the cancer cells can’t hide, so the immune system can recognise and kill them.
 
The aims of this study were to find out:
  • whether atezolizumab is helpful for people with urothelial cancer
  • more about the side effects

Summary of results

The research team found that atezolizumab could help stop urothelial cancer growing in some people. And that it didn’t cause too many side effects.
 
This trial was open for people to join between 2014 and 2015. The research team first published results in 2016.
 
About this trial
This trial recruited 438 patients, including:
  • 315 who’d had treatment before, but their cancer had started to grow again
  • 123 who’d been recently diagnosed and hadn’t had treatment yet
Everyone taking part had atezolizumab through a drip into a vein, once every 3 weeks. How long they had treatment depended on their individual situation.
 
The research team measured the amount of PD-L1 protein on cells in the immune system of the people who took part. They grouped people depending on how much PD-L1 they had on their immune cells. The groups were:
  • IC0 – the least amount of PD-L1
  • IC1 – a medium amount of PD-L1
  • IC2/3 – the most PD-L1
Results for people who’d had treatment before
The research team looked at how many people’s cancer went away or got smaller. They found it was 49 out of 310 people treated (16%). 
 
They also looked at this depending on the amount of PD-L1 protein people had on their immune cells. It was:
  • 9 out of 103 people (9%) with the least amount of PD-L1 (IC0)
  • 12 out of 107 people (11%) with a medium amount of PD-L1 (IC1)
  • 28 out of 100 people (28%) with more PD-L1 (IC2/3)

They looked at how many people were living after 1 year. This is called 12 month overall survival. They found it was more than 3 out of 10 people (35%). Again, they looked at this according to the IC group. They found that it was:
  • just under 3 out of 10 people (29%) for those in the IC0 group
  • 3 out of 10 people (30%) for those in the IC1 group
  • just under 5 out of 10 people (48%) for those in the IC2/3 group
The research team looked at the results again in 2017. They wanted to see how well people did if they carried on with atezolizumab after their cancer had started to grow again. 
 
They did this for 220 people whose cancer had started to grow again. Of these:
  • 137 carried on having atezolizumab
  • 19 had other treatment
  • 64 didn’t have any more treatment
They looked at what they call the median overall survival. This is the time from when the cancer started to grow until the point at which half the patients are living.
 
The median overall survival was:
  • 8.6 months for those who continued with atezolizumab
  • 6.8 months for those who changed to a different treatment
  • 1.2 months for those who didn’t have any more treatment
Results for people who hadn’t had treatment before
The research team looked at how many people’s cancer went away or got smaller. They found it was 27 out of 119 people treated (23%).
 
They also looked at this depending on the amount of PD-L1 people had on their immune cells. It was:
  • 8 out of 39 people (21%) with the least amount of PD-L1 (IC0)
  • 10 out of 48 people (21%) with a medium amount of PD-L1 (IC1)
  • 9 out of 32 people (28%) with the most PD-L1 (IC2/3)

They looked at how many people were living after 1 year. This is called 12 month overall survival. They found that it was more nearly 6 out of 10 people (57%). Again, they looked at this according to the IC group. They found there wasn’t much difference between the groups. It was:
  • just under 6 out of 10 people (59%) for those in the in the IC0 group
  • more than 5 out of 10 people (56%) for those in the IC1 group
  • just over 5 out of 10 people (52%) for those in the IC2/3 group
Side effects
The people in both groups had similar side effects. About 7 out of 10 people in each group had at least one side effect. But many were mild or didn’t last long. The less serious side effects included tiredness, feeling sick, diarrhoea and itchy skin.
 
Fewer than 2 out of 10 people in each group had more serious side effects. These included:
  • extreme tiredness (fatigue)
  • a change in liver function 
  • inflammation of the lung (pneumonitis)
Conclusion
The research team concluded that atezolizumab could be a useful treatment for people with urothelial cancer that has spread. And that the amount of PD-L1 protein on people’s immune cells can affect how well treatment works. They found that it didn’t cause too many side effects.
 
They suggest it is looked at further in a larger phase 3 trial
 
Where this information comes 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.

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

Professor Thomas Powles

Supported by

F. Hoffmann - La Roche Limited
NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:

12352

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

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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