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

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  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  or an organ transplant
• 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  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  (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)
• have had a live vaccine  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  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  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