A trial of durvalumab after treatment for bladder cancer (BL13)

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. 

Who can take part

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

• have urinary bladder cancer that has grown into the muscle wall of the bladder but no further
• have had surgery called a trans urethral removal of bladder tumour (TURBT) to remove the tumours in the bladder
• have had chemotherapy and radiotherapy for bladder cancer before you joined this trial. The trial doctor checks the exact type of treatment you had to ensure you are suitable to take part.  
• have had a CT scan within 8 weeks of joining the trial that shows the cancer hasn’t spread 
• can start treatment within 42 days of having surgery, chemotherapy and radiotherapy for bladder cancer 
• can start durvalumab or join the observation group within 2 days of being put into a group in the trial
• weigh more than 30kg (4.7 stone)
• have a sample of tissue (biopsy ) available for the trial team to do some tests on
• have satisfactory blood test results 
• are well enough to be up and about for at least half the day (performance status 0, 1 or 2) 
• are able to speak and read English well 
• are willing to use reliable contraception during treatment and for 3 months after durvalumab if there is any chance you or your partner could become pregnant
• are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related 
You:

• have cancer that has spread elsewhere in the body 
• have any other cancer unless it won’t affect you taking part in this trial 
• have already had durvalumab, ipilimumab or similar drugs in the past 
• have had a drug called carboplatin in the past 

Medical conditions
You can’t take part if:

• have a heart problem that needs treatment such as congestive heart failure or angina 
• have a tummy ulcer or inflammation of the tummy lining (gastritis)
• have an increased risk bleeding 
• have a problem with your immune system
• have had a severe reaction to an immunotherapy in the past
• have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the last month unless it was a very small dose, a cream or inhaler
• have had an organ transplant  and need to have treatment to damp down your immune system 
• have an autoimmune disease  unless it is loss of skin colour (vitiligo), type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications or a skin condition that doesn’t need treatment within 3 years of joining this trial
• have had tuberculosis (TB)
• have HIV
• have an active hepatitis B or hepatitis C infection
• have a serious problem with your digestive system  that causes diarrhoea
• have moderate to severe numbness or tingling in your hands or feet 
• have a condition called QT prolongation 
• have a condition called interstitial lung disease such as inflammation of the lung (pneumonitis )
• have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial

Other
You can’t take part if:

• are allergic to durvalumab or anything it contains 
• have had a live vaccine  in the 30 days before being put into a treatment group 
• are pregnant or breastfeeding