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Study identifier: NCT06607302 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Cholangiocarcinoma  ·  Sponsor: iOMEDICO AG

PhaseN/A
Planned participants100
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sina Grebhardt, PhD  ·  +49 761 15 242 31  ·  sina.grebhardt@iomedico.com

Always discuss trial participation with your own doctor first.

Locations (13)

Hämatologisch-Onkologische Schwerpunktpraxis in Bad LiebenwerdaBad Liebenwerda, GermanyRecruiting
Caritas Krankenhaus Bad MergentheimBad Mergentheim, GermanyRecruiting
Onkologisches Versorgungszentrum Berlin MVZBerlin, GermanyRecruiting
Gemeinschaftspraxis Hämatologie - OnkologieDresden, GermanyRecruiting
Onkozentrum DresdenDresden, GermanyRecruiting
Universitätsklinikum Essen, Innere Klinik (Tumorforschung)Essen, GermanyRecruiting
Onkologie HannoverHanover, GermanyRecruiting
Onkologie HofHof, GermanyRecruiting
Medizinisches Versorgungszentrum MönchengladbachMönchengladbach, GermanyRecruiting
TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Innere Medizin IIMünchen, GermanyRecruiting
Gemeinschaftspraxis für Internistische Onkologie und HämatologieRheine, GermanyRecruiting
RoMed Klinikum Rosenheim, Hämatologie und OnkologieRosenheim, GermanyRecruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06607302