Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

To join this study, you need to be at least 18 years old. You must have advanced bile duct cancer that doctors consider 'unresectable' (meaning surgery isn't an option) or has spread to other parts of the body. Importantly, you shouldn't have received previous treatment for this advanced cancer, though prior treatment given to prevent recurrence after earlier surgery (adjuvant treatment) might be allowed if it was more than 3 months ago.

Your cancer must also show a specific marker called HER2. Doctors will check this by looking at a recent tumour sample. You should be generally well enough to take part, meaning you can do most of your daily activities without much difficulty, and your important organs (like your kidneys, liver, and blood) are working well. If you are a woman who could become pregnant, you would need to have passed menopause or have a negative pregnancy test.

There are some reasons why you wouldn't be able to join. For example, if you've already had treatments that target HER2, other similar new drugs, or certain immune-boosting therapies. Also, if you have a specific type of bile duct cancer called ampullary carcinoma, or certain heart conditions, or untreated brain or spinal cord problems, you might not be eligible. The study doctors will carefully check all these details to make sure the study is safe and appropriate for you.

If you decide to join this study, you will be assigned to one of the treatment groups (either the new drug combinations or the standard treatment). You will receive your assigned medication, which will involve regular visits to the clinic for treatment and check-ups. During these visits, the study team will carry out various assessments, such as blood tests, scans (like CT or MRI), and physical examinations, to monitor your health, how the treatment is working, and any side effects you might experience. You will also be asked to provide a tumour sample that is no older than 3 years. The total length of your participation will depend on how you respond to the treatment and the study plan, but there will be ongoing follow-up to monitor your progress and health.