A study looking at matching treatment to the individual make up of bladder cancer (GUSTO)

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 the first part of this study (registration) if all of the following apply.

• Your doctor thinks you may go on to have chemotherapy followed by surgery with the aim to cure. And you are suitable to have any of the treatments in the study including immunotherapy .
• You have muscle invasive bladder cancer that is pure or mixed urothelial (transitional) cell carcinoma. Your doctor will know this. 
• You are fit and active but might not be able to do heavy physical work (performance status 0 or 1).
• You are at least 18 years old.

You may be able to join the main part of the study to have treatment if all of the following apply. You:

• joined the registration part of the study
• have muscle invasive cancer that has grown into the muscle wall of the bladder or has spread to the prostate, womb or vagina but no further. This is T2-4a, N0, M0 . Or you have cancer that may have grown into the wall of the bladder and beyond, has spread to only 1 lymph node but hasn’t spread to distant parts of the body. This is T(any), N1, M0 stage cancer. Your doctor will confirm this on a scan to check you are suitable to take part.
• weigh more than 30kg 
• have satisfactory blood test results. 
• are willing to use reliable contraception during the study and for a period after if there is any chance you or your partner could become pregnant 

Who can’t take part

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

• The study team can’t identify the gene subtypes in the cancer cells. 
• It takes too long to get the test results from the gene subtype test.
• You have cancer that has spread to distant parts of the body. 
• You have cancer that has spread to the tissues that surround the brain.
• You have had durvalumab in the past or have previously taken part in another trial involving durvalumab. 
• You are having chemotherapy, targeted cancer drugs or hormone treatment for cancer. This doesn’t apply to hormone replacement therapy. 
• You have had radiotherapy to more than a quarter of your body within 4 weeks of starting study treatment. 
• You have or had another cancer. You can join if you had successfully treated non melanoma skin cancer , carcinoma in situ of the cervix or early prostate cancer. 

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

• had a significant heart problem in the last 6 months or a heart condition that isn’t well controlled with medication. Your doctor checks your heart before you join the study. 
• have a problem with your heart rhythm
• have a problem with how your kidneys work 
• have scarring of the lungs (interstitial lung disease)
• have a serious problem with your gut that means you have a lot of diarrhoea
• have an active autoimmune condition apart from certain ones or you have an inflammatory disorder such as colitis or Crohn’s disease. Your doctor will know about this. 
• have had major surgery in the last 28 days 
• have moderate to severe side effects from past treatments that aren’t getting better. This doesn’t include hair loss or white patches on the skin (vitiligo). 
• have had treatment that damps down the immune system in the 2 weeks before you are put into a treatment group. This includes steroids within 2 weeks unless it was a low dose. 
• have a problem with how your immune system works 
• have HIV, an active hepatitis B or hepatitis C infection, tuberculosis or any other severe infection that needs treatment 
• have had a stem cell transplant with somebody else’s cells (allogeneic transplant ) in the past 
• had serious side effects from an immunotherapy or a similar drug that meant you had to stop it. If you had an immunotherapy in the past, all non serious side effects must be completely better. 
• have any other medical condition, mental health condition or there is any other reason that could affect you taking part 

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

• can’t have cisplatin, gemcitabine, durvalumab or tremelimumab for any reason
• have had a live vaccine in the 30 days before you are put into a treatment group. This doesn’t apply to the approved COVID-19 vaccines as these aren’t live. 
• are allergic to any of the study treatments or anything they contain
• are pregnant or breastfeeding