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

NCT06607302 | Recruiting

• 1 other identifier: iOM-040498
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS is defined as the time interval measured from the day of first ivosidenib administration to first progression or death, whichever comes first. Patients without tumor progression or death at the time of analysis will be censored at their date of last contact.

  max. 38 months (FPI - LPLV)

Secondary Outcomes (25)

• Overall survival (OS)

  max. 38 months (FPI - LPLV)

• Timt to treatment failure (TTF)

  max. 38 months (FPI - LPLV)

• Overall response rate (ORR)

  max. 38 months (FPI - LPLV)

• Disease control rate (DCR)

  max. 38 months (FPI - LPLV)

• (Serious) adverse events ((S)AE))

  max. 38 months (FPI - LPLV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with IDH1 R132-mutated locally advanced or metastatic CCC who have received at least one prior line of systemic therapy and who have already been scheduled by their treating physician to receive ivosidenib prior to enrolment in IDHIRA are eligible to participate.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iOMEDICO AG: lead
• Servier Deutschland GmbH: collaborator

Study Sites (7)

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

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Storage location of tumor samples collected during clinical routine will be documented within a virtual biobank

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Sina Grebhardt, PhD

CONTACT

+49 761 15 242 31; sina.grebhardt@iomedico.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 23, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

DE (7)