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Recruiting NCT06607302

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

— Observational Cholangiocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cholangiocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Progression-free survival (PFS) [Time frame: max. 38 months (FPI - LPLV)]
Secondary outcome measures (12)
  • Overall survival (OS) [Time frame: max. 38 months (FPI - LPLV)]
  • Timt to treatment failure (TTF) [Time frame: max. 38 months (FPI - LPLV)]
  • Overall response rate (ORR) [Time frame: max. 38 months (FPI - LPLV)]
  • Disease control rate (DCR) [Time frame: max. 38 months (FPI - LPLV)]
  • (Serious) adverse events ((S)AE)) [Time frame: max. 38 months (FPI - LPLV)]
  • (Serious) adverse drug reactions ((S)ADR) related to ivosidenib [Time frame: max. 38 months (FPI - LPLV)]
  • Adverse events of special interest (AESI) [Time frame: max. 38 months (FPI - LPLV)]
  • Global health-related quality of life during course of treatment [Time frame: max. 38 months (FPI - LPLV)]
  • Cholangiocarcinoma-related quality of life during course of treatment [Time frame: max. 38 months (FPI - LPLV)]
  • Assessing parameters of physician treatment decision making [Time frame: max. 30 months (recruitment period)]
  • Assessing parameters of physician treatment satisfaction [Time frame: max. 32 months (recruitment period plus 8 weeks)]
  • Cumulative ivosidenib dose [Time frame: max. 38 months (FPI - LPLV)]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 16 centers
  • Universitätsklinikum Augsburg, II. Medizinische Klinik — Augsburg
  • Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda — Bad Liebenwerda
  • Caritas Krankenhaus Bad Mergentheim — Bad Mergentheim
  • DRK Kliniken Berlin, Klinik für Innere Medizin — Berlin
  • Onkologisches Versorgungszentrum Berlin MVZ — Berlin
  • Gemeinschaftspraxis Hämatologie - Onkologie — Dresden
  • Onkozentrum Dresden — Dresden
  • Universitätsklinikum Essen, Innere Klinik (Tumorforschung) — Essen
  • … and 8 more centers

Publications

  • Michl M, Hagemeyer N, Looss M, Grebhardt S, Ringwald K, Potthoff K. IDHIRA: a prospective, observational study on ivosidenib in patients with IDH1 R132-mutated advanced cholangiocarcinoma. Future Oncol. 2025 Apr;21(9):1057-1064. doi: 10.1080/14796694.2025.2470609. Epub 2025 Mar 3. PMID 40028796

Identifiers

NCT: NCT06607302 · iOM-040498

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗