A trial of atezolizumab for urothelial cancer (urinary tract cancer) after surgery (W029636)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bladder cancer

Status:

Closed

Phase:

Phase 3

This trial is for people whose cancer has grown into the muscle layer of the bladder or upper urinary tract (invasive urothelial cancer). And whose cancer hasn't spread elsewhere in the body. 

The urinary tract includes the:

  • centre of the kidney (renal pelvis)
  • tube that takes urine from the kidneys to the bladder (ureter)
  • bladder

More about this trial

Removing the bladder (a cystectomy) or the kidney and ureter (a nephroureterectomy) is the usual treatment for invasive urothelial cancer.

You are then followed up to see if there are any signs of the cancer coming back. In this trial, researchers want to see if having atezolizumab after surgery delays or prevents the cancer coming back.

Atezolizumab (also known as MPDL3280A) is an immunotherapy Open a glossary item. It works by affecting a substance called PD-L1.  When cancer cells have a lot of PD-L1 on their surface, the immune system doesn’t work properly in getting rid of them. 

Atezolizumab blocks the way PD-L1 works (the PD-L1 pathway) and so could help your immune system to stop or shrink the cancer growth. 

If a cancer has large amounts of PD-L1, it is described as being PD-L1 positive. To be able to take part in this trial you must be PD-L1 positive. Your doctors will test for this.  

Some people in this trial have atezolizumab after surgery. The other group don’t have treatment and are followed up as usual. 

The aims of this trial are to 

  • find out how well atezolizumab works for people after surgery for urothelial cancer
  • learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this trial if all of the following apply.

  • You have transitional cell bladder cancer or upper urinary tract cancer and

    • You have cancer that has grown into the muscle layer of the bladder or beyond (stage T2 to T4a) or it has spread into the lymph nodes and you had chemotherapy before surgery OR

    • You have cancer that has grown through the muscle and outside of the bladder (stage T3 –T4a) or into the lymph nodes and you didn’t have chemotherapy before surgery
  • You have had a cystectomy or nephroureterectomy, your lymph nodes removed and the surgeons were able to remove all of the cancer
  • There are enough samples of your cancer available for the trial team to do some tests
  • If you didn’t have chemotherapy before surgery, there is a reason why you might not be able to have cisplatin chemotherapy afterwards. For example you aren’t well enough or your kidneys aren’t working properly
  • You have fully recovered within 14 weeks of having surgery
  • You are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 5 months afterwards if there is any chance that you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have bladder cancer that has spread to another part of the body 
  • Have already had a drug that targets PD-1, PD-L1, CD137, CD40 or CTLA-4 such as ipilimumab, nivolumab or pembrolizumab
  • Have had any other cancer treatment in the 3 weeks before starting treatment in this trial
  • Have had treatment that stimulates the immune system such as interferon or IL-2 in the last 6 weeks before joining the trial
  • Have had steroid treatment in the 2 weeks before joining the trial
  • Have an autoimmune disease Open a glossary item such as rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, myasthenia gravis. If you have a condition of auto immune related hypothyroidism and are on a stable dose of thyroid replacement hormone you may be able to take part in the trial. And if you have type 1 diabetes and are on a stable dose of insulin you might also be able to take part.  
  • Have a lung condition called interstitial lung disease
  • Have problems with your heart, such as a heart attack in the last 3 months, angina that is not well controlled or an abnormal rhythm of your heart
  • Have had any other cancer in the last 5 years, apart from low risk prostate cancer or certain cancers that were very early stage and have been successfully treated such as non melanoma skin cancer Open a glossary item or CIS of the cervix
  • Have had a stem cell transplant Open a glossary item with someone else’s cells or an organ transplant
  • Have had an allergic reaction to atezolizumab or you are sensitive to any drugs that are similar or that are produced in a similar way
  • Have been in hospital with a serious infection in the 4 weeks before starting trial treatment or you have had any signs or symptoms of a serious infection in the last 2 weeks
  • Have had antibiotics in the last 2 weeks before joining the trial
  • Are HIV positive
  • Have an active hepatitis B or hepatitis C infection
  • Have tuberculosis (TB) causing symptoms 
  • Have had major surgery in the last month
  • Have had a live vaccination Open a glossary item in the last month
  • Have had any other experimental treatment as part of a clinical trial in the last 4 weeks
  • Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This international phase 3 trial needs about 25 people from the UK to take part. 

The trial is randomised. You are put into 1 of 2 treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in.

The people taking part are put into 1 of 2 groups.

  • One group have atezolizumab
  • The other group don’t have treatment (this is called the observation group)

Diagram showing W02936 trial design

In the atezolizumab group, you have treatment once every 3 weeks. You have it as a drip into a vein. It takes about an hour each time. You continue having treatment for up to a year as long it is helping you and the side effects aren’t too bad. 

In the observation group you see the trial team every 3 weeks for a year or they will phone you at home to see how you are getting on. This is the usual way of following people up after upper urinary tract cancer surgery who are not able to have cisplatin chemotherapy.

Research samples
The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item. They will use these samples to better understand bladder cancer and find out why some people don’t respond to some treatments.

They will also ask to take extra blood and urine tests as part of this trial to look for biomarkers Open a glossary item.

You don’t have to give these extra samples if you don’t want to. You can still take part in the trial.

Hospital visits

You see trial doctors and have some tests before you start treatment. These include

  • A physical examination
  • Blood tests
  • Urine tests
  • Heart trace (ECG Open a glossary item)
  • CT scan or MRI scan

You might also have a scan of the kidneys and the tubes draining the kidneys called the ureters.

You have regular scans while you are taking part in the trial. When the trial finishes, you have a CT or MRI scan every 

  • 3 months for the first 3 years
  • 6 months for the following 3 years

The trial team will contact you by phone every 3 months for up to 6 years to see how you are getting on.

Side effects

As atezolizumab is a new drug there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything. 

So far, the most common side effects include

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

Dr Alison Birtle

Supported by

Experimental Cancer Medicine Centre (ECMC)
Roche

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13931

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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