A trial of chemotherapy and durvalumab for bladder cancer (NIAGRA)

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 transitional cell or urinary bladder cancer that has grown into the muscle wall of the bladder but no further 
• are well enough to have treatment before surgery to remove the bladder
• are due to have an operation to remove the bladder
• are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
• weigh more than 30kg (4.7 stone)
• have satisfactory blood test results  
• are willing to use reliable contraception during treatment and for 3 months after durvalumab and 6 months after chemotherapy 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 to the lymph nodes  or the area between the hip bones (pelvis) or tummy (abdomen)
• have cancer that has spread elsewhere in the body
• need to have an operation to remove the kidney or tubes that carry urine from the kidneys to the bladder (ureter)
• have already had chemotherapy or immunotherapy in the past for bladder cancer that has grown into the muscle of the bladder (you might be able to join if you had BCG into the bladder) 
• have cancer that can’t be removed with an operation
• have had durvalumab and tremelimumab in the past
• had or are having chemotherapy, a targeted drugs , immunotherapy  or hormone treatment
• have had radiotherapy to the area between the hip bones (pelvis) within 2 years of joining the study
• have side effects from past treatments that aren’t getting better apart from hair loss or loss of skin colour (vitiligo)
• can’t have cisplatin because you have moderate hearing loss or numbness and tingling in your hands and feet
• have had another cancer unless it was basal cell cancer , squamous cell cancer , carcinoma in situ  or any other cancer that you have had treatment for more than 5 years ago and there are no signs of it coming back
• are taking part in another clinical trial 

Medical conditions
You:

• had an organ transplant  and need to have medication to damp down the immune system
• have an autoimmune disease  such as colitis or Chron’s disease unless it is a skin condition called vitiligo, hair loss or problems with your thyroid gland  that are stable
• had a heart attack in the last 6 months or you have other heart problems that need treatment 
• have a problem with your immune system and it doesn’t work properly 
• have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the last 2 weeks unless it was a very small dose, a cream or inhaler
• have a condition called leptomeningeal carcinomatosis
• have had surgery in the last month
• have breathing problems due to inflammation and scarring of the lungs (a condition called interstitial lung disease)
• have serious problems with your digestive system  that cause diarrhoea
• have an active infection including tuberculosis, hepatitis B, hepatitis C or HIV
• have any other medical condition or mental health problem that the trial team think would affect you taking part

Other
You: 

• are pregnant or breastfeeding 
• are allergic to any of the drugs in the trial 
• have had a live vaccine  in the last 30 days