A trial looking at rilvegostomig and chemotherapy after surgery for bile duct and gallbladder cancer (ARTEMIDE-Biliary01)

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 adenocarcinoma  of the bile duct or gallbladder that has been completely removed with surgery. Or there might be some cancer cells left behind at the edges of the removed tissue when examined under the microscope. Your doctor will know this. You may be able to take part if you have mixed cancer cells as long as most of them are adenocarcinomas or adenosquamous carcinoma. Your doctor will know this.
• have a sample of cancer tissue that was removed during surgery that the team can do some tests on. One of the tests is to check if you have a protein called PD-L1 in your cancer cells or not. 
• are put into a treatment group within 12 weeks of having surgery to treat your cancer. You must have recovered from surgery and had any surgical drains removed.
• have no signs of cancer on a CT scan  or MRI scan  and no moderate to severe areas of fluid collection in the tummy within 4 weeks of being put into a treatment group
• are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results 
• weigh at least 30kg 
• are willing to use reliable contraception during the trial and for a period after 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. You:

• have cancer that has spread into the surrounding tissues and can’t be removed with surgery or it has spread to another part of the body 
• have had treatment for bile duct or gallbladder cancer before your surgery. This might have included chemotherapy, targeted cancer drugs , an immunotherapy  or a cancer vaccine .
• have ampullary cancer, neuroendocrine cancer, mixed neuroendocrine cancer, non neuroendocrine cancer or nonepithelial tumours. Your doctor will know this.
• are taking an experimental drug or using a device as part of another clinical trial
• have had another cancer in the past. You could join if you had successfully treated non melanoma skin cancer , lentigo maligna  or carcinoma in situ . You could join if you had another cancer in the last 2 years and there have been no signs of it since or it has a low chance of coming back.
• have already been enrolled in this trial or put into a treatment group even if you didn’t have treatment 

Medical conditions

You cannot join this trial if any of these apply. You:

• have had a heart attack in the last 6 months or a significant heart problem  that needs treatment. The trial team check if you have a heart condition before you join the trial. 
• have had a blood clot within 3 months of starting trial treatment 
• have high blood pressure that isn’t well controlled with medication
• have an autoimmune condition  that needs treatment apart from certain ones or you had one in the last 5 years. Your doctor will know about this. 
• have had medication to damp down the immune system  within 2 weeks days of starting rilvegostomig. This includes steroids  unless it was a low dose.
• have had major surgery that wasn’t the surgery to remove your cancer or a significant traumatic injury within 4 weeks of starting rilvegostomig or you might need major surgery during the trial 
• have an inflammatory disorder such as Crohn’s disease or a serious condition that affects your digestive system  
• have a bleeding problem
• have scarring on the lungs or active inflammation of the lungs (pneumonitis ) 
• have an active skin disease such as skin rash or psoriasis that needs treatment to the whole body
• have HIV that isn’t well controlled, an active hepatitis B or hepatitis C infection that isn’t well controlled with medication, active tuberculosis  or any other severe infection that needs treatment 
• have had an organ transplant  in the past 
• have a deficiency in the DPD enzyme  that could make the side effects of certain chemotherapy drugs worse. This is only if you are put into the group having capecitabine chemotherapy. 
• can’t swallow or absorb medication if you are in the group having capecitabine or S-1 chemotherapy 
• have another medical condition or mental health condition that could affect you taking part or there is any other reason the team think you won’t be suitable for the trial 

Other

You cannot join this trial if any of these apply. You:

• are pregnant, breastfeeding or planning to become pregnant during the trial and for a period after 
• are allergic to any of the treatments in the trial or anything they contain