Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma

You might be able to join this study if you are 18 years or older and have been diagnosed with a specific type of bile duct cancer called intrahepatic cholangiocarcinoma. Importantly, your cancer must have had surgery to remove it completely, and it must have a particular genetic fault known as the IDH1 mutation. You should also have recently finished six months of standard chemotherapy for your cancer, and scans must show you are currently cancer-free.

There are also some health requirements, such as having good general health and normal function of certain organs like your liver, kidneys, and blood. If you are a woman who could become pregnant, or a man with a female partner who could become pregnant, you would need to agree to use effective contraception during and for some time after the study treatment.

If you decide to join this study, you will receive the study drug, ivosidenib, as a pill once a day for up to 12 months. Throughout this time, you will have regular check-ups every 8 weeks, which will likely include scans and other tests to see how you are responding to the treatment and to check for any side effects. After the 12 months of treatment, you will continue to have follow-up appointments every 12 weeks to monitor your health and ensure the cancer has not returned. Overall, your health will be monitored for up to 48 months (4 years) from the time the last person joins the study, or until your enrolment ends for other reasons.