Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

To join this study, you must have a confirmed diagnosis of bile duct cancer (cholangiocarcinoma) that is locally advanced, cannot be removed by surgery, or has spread. Importantly, your cancer cells must show a specific genetic change called an IDH1 mutation.

You also need to be at least 18 years old and generally well enough to take part, with normal bone marrow, liver, and kidney function. This means your body needs to be able to handle the treatments involved. Doctors will check these things with blood tests.

There are also reasons you might not be able to join. For example, if you've already had many treatments for your advanced bile duct cancer, or if you've previously received certain types of immunotherapy. You also shouldn't have any other serious medical conditions that might make taking part risky.

If you join this study, you will receive a combination of medicines: ivosidenib, durvalumab, gemcitabine, and cisplatin. The first 8 treatment cycles will combine all these medicines, with durvalumab continuing after that. Each treatment cycle for the first 8 cycles lasts 21 days, and then subsequent cycles will be 28 days long.

During your treatment, you'll have regular hospital visits. In the first cycle, you'll visit on days 1, 8, and 15. For cycles 2 to 8, you'll visit on days 1 and 8. After that, you'll visit on day 1 of each new cycle. These visits will involve various checks, including blood tests, heart readings (ECG), measuring your vital signs (like blood pressure and temperature), and a physical examination to monitor your health and how the treatment is working.

After your treatment period finishes, you'll have follow-up safety visits approximately 30 and 90 days later. Following these, doctors will continue to check in with you about your survival every three months for an extended period. The study involves two phases: a first phase to find the best and safest dose of the medicine combination, followed by an expansion phase to see how well that dose works.