Observational study of ivosidenib in bile duct cancer with an IDH1 mutation
Follows adults with bile duct cancer carrying an IDH1 mutation who receive ivosidenib.
Plain-language title generated from the registry record
Registry title: Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
Key facts
- Where
- Augsburg, Bad Liebenwerda, Bad Mergentheim, Bamberg, Berlin, Dresden, Essen, Freiburg im Breisgau, Hanover, Hof, Mönchengladbach, München, Passau, Rheine, Rosenheim, and Weinheim, GermanySee the 19 sites
Where in Germany
- Universitätsklinikum Augsburg, II. Medizinische KlinikAugsburg, GermanyTaking people
- Hämatologisch-Onkologische Schwerpunktpraxis in Bad LiebenwerdaBad Liebenwerda, GermanyTaking people
- Caritas-Krankenhaus Bad MergentheimBad Mergentheim, GermanyTaking people
- Onkologische Schwerpunktpraxis BambergBamberg, GermanyTaking people
- DRK Kliniken Berlin, Klinik für Innere MedizinBerlin, GermanyTaking people
- Onkologisches Versorgungszentrum Berlin MVZBerlin, GermanyTaking people
- Sana Klinikum Lichtenberg, Innere Medizin IVBerlin, GermanyTaking people
- Gemeinschaftspraxis Hämatologie - OnkologieDresden, GermanyTaking people
- Onkozentrum DresdenDresden, GermanyTaking people
- Universitätsklinikum Essen, Innere Klinik (Tumorforschung)Essen, GermanyTaking people
- Universitätsklinikum Freiburg, Innere Medizin IFreiburg im Breisgau, GermanyTaking people
- Onkologie HannoverHanover, GermanyTaking people
- Onkologie HofHof, GermanyTaking people
- Medizinisches Versorgungszentrum MönchengladbachMönchengladbach, GermanyTaking people
- TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Innere Medizin IIMünchen, GermanyTaking people
- Onkologisches Zentrum PassauPassau, GermanyTaking people
- Gemeinschaftspraxis für Internistische Onkologie und HämatologieRheine, GermanyTaking people
- RoMed Klinikum Rosenheim, Hämatologie und OnkologieRosenheim, GermanyTaking people
- ze:roPRAXEN MVZ für Innere MedizinWeinheim, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- iOMEDICO AG
- Trial code
- NCT06607302
- Record updated
- 22 October 2026
- Original description
Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease. Ivosidenib was approved by European Medicines Agency (EMA) in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.Read full original descriptionShow less
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - a Prospective, Multicenter, Observational Study in Germany
Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease. Ivosidenib was approved by European Medicines Agency (EMA) in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
The prospective, multicenter, observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany. Ivosidenib will be administered according to the current SmPC. Thus, IDHIRA will generate real-world evidence on effectiveness, quality of life (QoL) and safety of ivosidenib.
Inclusion: Age 18 years or older; Histologically confirmed locally advanced or metastatic CCC with a documented IDH1 R132 mutation diagnosed by an appropriate diagnostic test; Patients must have at least one prior systemic therapy; Decision for treatment with ivosidenib according to current SmPC; Signed written informed consent before or within 6 weeks of first ivosidenib dose (inclusion of patients up to 6 weeks after first ivosidenib intake is allowed for patients not participating in the PRO module); For patients participating in the PRO module (optional):; Dated signature of informed consent form before start of study treatment; Willingness and capability to participate in PRO assessment in German language; Other criteria according to current SmPC.
Exclusion: Participation in an interventional clinical trial within 30 days prior to enrolment or concurrent participation in an interventional clinical trial except for the follow-up period; Other contraindications according to current SmPC.