A trial of durvalumab with chemotherapy for biliary cancer (TOPAZ-1)

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 you have one of the following cancers:

• bile duct cancer   
• gallbladder cancer  
• biliary tree cancer  

And at least one of the following applies. You: 

• have cancer that has grown into the surrounding tissue and cannot be removed by surgery 
• have cancer that has spread to another part of your body (metastatic)
• had your cancer removed by surgery with the aim to cure more than 6 months ago and it has come back (recurred). If you had further treatment after surgery it was completed more than 6 months ago. 

And all of the following apply. You: 

• have at least 1 area of cancer that the doctor can measure on a scan
• have satisfactory blood test results
• are fit and well but may not be able to do heavy physical work (performance status 0 and 1)
• weigh more than 30kg (4st 7lb)
• are willing to use reliable contraception during treatment and for 6 months after if you have chemotherapy and for 3 months if you have durvalumab
• 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 ampullary cancer
• have cancer that has spread to the brain or spinal cord
• have cancer that has spread to the membranes (meninges) surrounding the brain 
• have ongoing moderate side effects of previous cancer treatment apart from hair loss and lightening of your skin (vitiligo) 
• are currently having cancer treatment such as chemotherapy, hormone therapy, a targeted drug, immunotherapy or radioembolisation 
• had radiotherapy apart from radiotherapy after surgery to remove your cancer 

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

• have had an organ transplant 
• have an autoimmune disease or inflammatory disorder such as inflammatory bowel disease, diverticulitis, systemic lupus erythematosus or rheumatoid arthritis. You might be able to join if you have vitiligo, hair loss, hypothyroidism that is stable with hormone replacement therapy, ongoing skin condition not needing treatment that affects the whole body, celiac disease controlled by diet only or there has been no sign of this disease for at least 5 years 
• have an ongoing or active infection 
• have or have had heart problems such as a congestive heart failure that is causing symptoms, angina not controlled or problems with how your heart beats (rhythm) that isn’t controlled
• have high blood pressure that isn’t controlled
• have problems with your lungs such as scarring 
• have had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer, lentigo maligna, carcinoma in situ or another cancer that was treated with the aim to cure and there hasn’t been a sign of it in the past 5 years
• have an active disease that affects your immune system such as HIV
• have hepatitis B and hepatitis C. If you have hepatitis B only, you can join the trial but might need to have treatment for hepatitis B
• have hepatitis B and hepatitis D
• have tuberculosis (TB)
• have major surgery within 28 days of starting treatment
• are taking medication such as steroids that damp down your immune system within 14 days of starting treatment apart from inhalers, creams, injections into a joint and tablets with a dose of 10mg or less a day or used once only to stop an allergic reaction before a procedure such as a CT scan 
• have used an experimental drug or device in the past 3 months as part of another clinical trial
• are taking part in another clinical trial unless it is an observational study or you are in follow up 
• have had durvalumab before 
• are allergic or sensitive to the drugs or any of their ingredients used in this trial 
• have any other medical or mental health condition that your doctor or the trial team think will affect you taking part in the trial 

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

• had a live vaccine within 30 days of starting treatment, might have a live vaccine during treatment or within 30 days after finishing treatment
• are pregnant or breastfeeding