Using ivosidenib for advanced cholangiocarcinoma with IDH1 mutation after previous treatments

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

This study is testing how well the drug ivosidenib works for people with advanced bile duct cancer who have already tried other treatments and have a specific gene mutation.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: iOMEDICO AG (Industry-sponsored)
• Locations: 7 sites (Bad Liebenwerda and 6 other locations)
• Trial ID: NCT06607302 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world data on the effectiveness, quality of life, and safety of ivosidenib in patients with locally advanced or metastatic cholangiocarcinoma who have an IDH1 R132 mutation and have undergone at least one prior systemic treatment. The study will be conducted across multiple centers in Germany, allowing for a diverse patient population. Ivosidenib, an IDH1 inhibitor, was recently approved for this indication, and the study will follow patients receiving this treatment according to the current guidelines.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed locally advanced or metastatic cholangiocarcinoma and a documented IDH1 R132 mutation who have received at least one prior systemic therapy.

Not a fit: Patients who have not been previously treated with systemic therapy or those participating in other interventional clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of ivosidenib, potentially improving treatment options for patients with cholangiocarcinoma.

How similar studies have performed: While this approach is relatively novel, the use of targeted therapies like ivosidenib has shown promise in other studies for similar conditions.

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.

Where this trial is running

Bad Liebenwerda and 6 other locations

• Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda — Bad Liebenwerda, Germany (Recruiting)
• Caritas Krankenhaus Bad Mergentheim — Bad Mergentheim, Germany (Recruiting)
• Onkologisches Versorgungszentrum Berlin MVZ — Berlin, Germany (Recruiting)
• Onkologie Hannover — Hanover, Germany (Recruiting)
• Onkologie Hof — Hof, Germany (Recruiting)
• Medizinisches Versorgungszentrum Mönchengladbach — Mönchengladbach, Germany (Recruiting)
• ze:roPRAXEN MVZ für Innere Medizin — Weinheim, Germany (Recruiting)

Study contacts

• Study coordinator: Sina Grebhardt, PhD

Conditions Cholangiocarcinoma