A trial looking at atezolizumab for people with urinary tract cancer (urothelial cancer) (ABACUS-2)

Cancer type:

Bladder cancer
Kidney cancer

Status:

Open

Phase:

Phase 2

This trial is for people who are going to have surgery to try to cure their cancer. 

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) 

The lining of the urinary tract is called the urothelium, so cancer of the urinary tract is also called urothelial cancer.

More about this trial

Surgery is a common treatment for urinary tract cancer. The type of surgery you have depends on where your cancer started. You might have:

  • an operation to remove the kidney, ureter Open a glossary item and a small part of the bladder (nephroureterectomy) 
  • surgery to remove part of the ureter and part of the bladder (distal ureter resection)
  • surgery to remove all the bladder (cystectomy

Some people have a higher risk of their cancer coming back after surgery. So researchers are looking for a way to help people in this situation. In this trial, they are looking at a drug called atezolizumab

Atezolizumab is a type of immunotherapy. It works by blocking a protein that stops the immune system Open a glossary item from working properly and attacking cancer cells. Atezolizumab is already a treatment for a number of different types of cancer. 

Everyone taking part in this trial has atezolizumab and then surgery.  
 
The main aims of this trial are to find out:

  • if having atezolizumab before surgery stops urinary tract cancer from coming back
  • more about how atezolizumab works 

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 cancer that started in the layer of cells that line the urinary tract system (urothelial cancer)  
  • have a high risk of your cancer coming back (high grade) if you have cancer that started in the renal pelvis or ureter. Your doctor can tell you more about this.  
  • are going to have surgery to try to cure your cancer 
  • have had a CT or MRI scan to stage Open a glossary item your cancer in the last month  
  • have had a sample of tissue taken (biopsy) of your cancer and there is a sample available for the trial team to do some tests
  • have satisfactory blood test results
  • you can look after yourself but may not be able to do heavy physical work (performance status 0 or 1)
  • are willing to use contraception during this trial and for a certain time afterwards if there is any chance you or your partner could become pregnant 
  • are at least 18 years old

Who can’t take part

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

  • your cancer has spread to other parts of your body (metastatic cancer) 
  • you have had chemotherapy for urothelial cancer  
  • you have had a stem cell transplant from a donor Open a glossary item or an organ transplant Open a glossary item
  • you have had treatment with immunotherapy drugs such as ipilimumab, nivolumab or pembrolizumab
  • you have had another cancer in the last 5 years apart from successfully treated carcinoma in situ Open a glossary item of the cervix and breast, non melanoma skin cancer or localised prostate cancer
  • you are sensitive to atezolizumab or anything it contains 

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

  • have had a major operation in the past month or need to have one during this trial 
  • have had drugs that damp down your immune system Open a glossary item (steroids) in the past 2 weeks apart from inhalers, cream or steroids to replace hormones in the body
  • have had antibiotics in the past 2 weeks apart from antibiotics used to prevent a urinary tract infection (UTI) Open a glossary item
  • have had a live vaccine Open a glossary item in the last month 
  • have had drugs that stimulate your immune system such as interleukin 2
  • have had an experimental drug in the last 4 weeks 
  • have had a severe infection in the past month such as pneumonia 
  • have problems with your heart such as angina Open a glossary item that isn’t stable, an abnormal heart rhythm or you have had a heart attack in the past 3 months
  • have problems with your lungs such as inflammation of the lung tissue (pneumonitis) 
  • have type 1 diabetes that isn’t controlled   
  • are known to be HIV, hepatitis B or hepatitis C positive
  • have active tuberculosis 
  • have a condition that affects the way you absorb drugs
  • have an autoimmune disease Open a glossary item such as lupus, autoimmune hepatitis, inflammatory bowel disease or multiple sclerosis 
  • have high levels of calcium (hypercalcaemia)  

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

  • have taken part in a clinical trial looking at a new drug in the last month 
  • have any other medical condition that the trial doctors think could affect you taking part 
  • are pregnant or breastfeeding  

Trial design

This is a phase 2 trial. Researchers hope that 58 people from the UK, Spain and France will agree to take part. 

Everyone taking part has up to 2 doses of atezolizumab before surgery. You have it as a drip into your bloodstream (intravenously). It takes about an hour each time you have it. 

After atezolizumab, you have surgery. This is the same as you would have if you weren’t taking part in this trial. The type of surgery you have depends on where your cancer is. Your doctor can tell you more about this. 

Research samples
The trial team asks for blood and urine samples. They will use these samples to understand more about how atezolizumab works. Where possible, you have these taken at the same time as your routine blood tests.

You have research samples taken:

  • before the start of atezolizumab
  • during treatment with atezolizumab
  • before surgery 
  • then 1, 3 and 6 months after surgery

The trial team will also ask you for a sample of your cancer that was taken when you had a biopsy Open a glossary item. And a sample of your cancer taken during the operation. They want to find out more about how atezolizumab affects your cancer. 

Hospital visits

You see a doctor and have some tests before taking part. The tests you might have include:

You see the trial team before each atezolizumab treatment and before the operation. After surgery, you see the trial team after:

  • 4 weeks
  • 3 months 
  • 6 months

The trial team will also contact you by phone after 1 and 2 years to see how you are.

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. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some 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 information about the side effects of atezolizumab.

Location

London
Oxford

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

Queen Mary University of London 
Roche

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18443

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

Cara took part in a clinical trial

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"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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