A trial looking at atezolizumab for cancers of the urinary tract (AURORA)

Cancer type:

Bladder cancer
Kidney cancer

Status:

Open

This trial is open to people with a squamous cell cancer Open a glossary itemof the urinary tract. It is for people whose aim of their treatment is to control symptoms (palliative treatment Open a glossary item ).

The urinary tract includes 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)

More about this trial

Squamous cell cancer of the urinary tract is not a common cancer. Researchers are always looking for better treatments for these cancers. 

Atezolizumab is an immunotherapy. It works by helping the immune system Open a glossary item find and kill cancer cells. Atezolizumab is already used to treat some cancers. This includes some common cancers of the urinary tract but not squamous cell cancers of the urinary tract.  

Researchers think that atezolizumab could help people with a squamous cell cancer of the urinary tract. 

The main aims of the trial are to find out:

  • how well atezolizumab works 
  • what the side effects are
  • how it affects quality of life Open a glossary item 

Who can enter

The following bullet points are a summary of 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.

Who can take part

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

  • have a cancer of the bladder or cancer of the kidneys that is a squamous cell cancer  Open a glossary item
  • have just been diagnosed or your cancer has got worse 
  • have an area of cancer that the doctor can measure on a scan
  • are able to have atezolizumab with the intent to control symptoms of your cancer palliative treatment Open a glossary item 
  • have had no more than 1 course of treatment Open a glossary item that reaches the whole body (systemic treatment) Open a glossary item 
  • have satisfactory blood test results
  • are up and about, can look after yourself but might not be able to work (performance status 0, 1 or 2)
  • are willing to use contraception during treatment and for a certain time after if there is any chance you or your partner could become pregnant
  • have a tissue sample (biopsy Open a glossary item)that the trial team can ask for and get
  • are at least 18 years old 

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

  • have transitional cell cancer Open a glossary item (TCC) or any part of the cancer is TCC 
  • are due to have treatment with the aim to cure 
  • have had an immunotherapy Open a glossary item. This is apart from BCG for bladder cancer. 
  • have had an experimental drug or used a device as part of a clinical trial within 4 weeks of going into the trial
  • have or had another cancer unless you have completed all active treatment at least 2 years ago or more. This is apart from successfully treated non melanoma skin cancer Open a glossary item, carcinoma in situ (CIS Open a glossary item)of the cervix and prostate cancer that was only in the prostate gland (localised Open a glossary item)

Medical conditions 
You cannot join this trial if any of these apply. You:

  • have major surgery within 30 days of going into the trial
  • have had steroids Open a glossary item within 2 weeks of going into the trial. This is apart from certain ones such as inhalers, your doctor will know more about this.
  • had a heart attack or unstable angina within the past 6 months. Or any other major heart problem Open a glossary item that could affect you taking part.
  • have HIV, active hepatitis B, active hepatitis C or active tuberculosis (TB) 
  • have or had an autoimmune disease Open a glossary item . This is apart from certain ones that your doctor will know about.
  • have scarring or inflammation of the lung tissue. You can join if this was caused by radiotherapy to the chest or lung. Ask your doctor about this.
  • have had a stem cell transplant from another person (allogeneic transplant Open a glossary item) or you have had an organ transplant Open a glossary item

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

  • are allergic or sensitive to atezolizumab or any of its ingredients
  • have a live vaccine Open a glossary item within 4 weeks of going into the trial. The COVID-19 vaccines aren’t live vaccines. 
  • are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The team need up to 36 people to take part.

Everyone has atezolizumab. You have it as a drip into a vein once every 4 weeks. This takes less than an hour. Each 4 week period is a cycle of treatment Open a glossary item

You can have treatment for up to a year (a maximum of 13 cycles). This is as long as it is helping and the side effects aren’t too bad. 

Quality of life
You fill in a questionnaire before starting treatment and then every 12 weeks until your cancer starts to grow again.  

The questions ask about:

  • your general health and wellbeing
  • what you are able to do in your daily life
  • side effects and symptoms

This is a quality of life questionnaire

Samples for research
The team ask for a piece of cancer tissue from a previous tissue sample (biopsy Open a glossary item). They must be able to get this for you to take part in the trial.

You give blood samples during the trial. Where possible the team take these when you have blood taken as part of your routine care. The team use the blood samples to see how well atezolizumab is working.

Hospital visits

You see the doctor to have tests before taking part. These include:

  • a physical examination Open a glossary item 
  • blood tests
  • CT scan

You have treatment as an outpatient Open a glossary item. During treatment you see the doctor every month. This is:

  • to see how you are
  • for blood tests 
  • to ask about any side effects or symptoms

You see the doctor a month after finishing treatment and then every 3 months. This is until your cancer starts to grow again. Your doctor will then tell you how often they want to see you.

You have a CT scan every 3 months while you are in the trial. 

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

Atezolizumab can affect the immune system Open a glossary item. This may cause inflammation Open a glossary item and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects. 

These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.
 
If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

 

The most common side effects of atezolizumab are:

We have more about atezolizumab and its side effects. 

Your doctor will talk to you about the possible side effects and answer any questions you have before you agree to take part. 
 

Location

Cardiff
Edinburgh
Glasgow
Liverpool
London
Manchester
Middlesbrough
Nottingham
Preston
Southampton
Sutton

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 Simon Crabb

Supported by

Cancer Research UK
Roche
University Hospital Southampton NHS Foundation Trust
Southampton Clinical Trials Unit
National Cancer Research Institute (NCRI)

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18842

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

Last reviewed:

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