Observational Study of Ivosidenib for Adults With Locally Advanced or Metastatic Cholangiocarcinoma Having IDH1 R132 Mutation After Prior Systemic Therapy in Germany

What this Trial Is About

Cholangiocarcinoma is a rare and aggressive bile duct tumor with poor outcomes and limited treatment options. Researchers are collecting real-world data on ivosidenib, an IDH1 inhibitor recently approved in Europe for adults with locally advanced or metastatic cholangiocarcinoma carrying an IDH1 R132 mutation who have undergone at least one prior systemic treatment. This observational study aims to evaluate ivosidenibs effectiveness, safety, and impact on quality of life in a broad patient population in Germany. Ivosidenib is given as monotherapy according to the current summary of product characteristics SmPC. The study follows patients receiving ivosidenib under routine clinical care without altering treatment decisions. It will gather data on treatment dosing, modifications, duration, and reasons for stopping treatment. Optional patient-reported outcomes PRO assessments are available for those who can participate in German. Participants are monitored during treatment and follow-up for up to 38 months from first patient in to last patient last visit. The study collects information on progression-free survival, overall survival, adverse events, quality of life related to cholangiocarcinoma, and physician treatment decisions. Data on prior therapies, concomitant medications, and subsequent cancer treatments are also recorded to assess real-world use and safety of ivosidenib.

Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study