CholangiocarcinomaIDHIRANCT06607302
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
An observational study of Cholangiocarcinoma, run by iOMEDICO AG at 19 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- How many people
- 100 participants
- Where
- 19 sitesGermany
- Study dates
- 8 Oct 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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):
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
Germany19 sites, 19 recruiting
- Recruiting
Universitätsklinikum Augsburg, II. Medizinische Klinik
Augsburg
Frank Jordan, Dr. med.
- Recruiting
Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda
Bad Liebenwerda
Stephan Kreher, PD Dr. med.
- Recruiting
Caritas Krankenhaus Bad Mergentheim
Bad Mergentheim
Matthias Raab, Dr.
- Recruiting
Onkologische Schwerpunktpraxis Bamberg
Bamberg
Stefan Fries, Dr. med.
- Recruiting
DRK Kliniken Berlin, Klinik für Innere Medizin
Berlin
Tobias Müller, Prof. Dr. med.
- Recruiting
Onkologisches Versorgungszentrum Berlin MVZ
Berlin
Reinhard Musch
- Recruiting
Sana Klinikum Lichtenberg, Innere Medizin IV
Berlin
Uwe Pelzer, Prof. Dr. med.
- Recruiting
Gemeinschaftspraxis Hämatologie - Onkologie
Dresden
Jens Freiberg-Richter, Dr. med.
- Recruiting
Onkozentrum Dresden
Dresden
Steffen Dörfel, Dr. med.
- Recruiting
Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
Essen
Ilektra-Antonia Mavroeidi, Dr. med.
- Recruiting
Universitätsklinikum Freiburg, Innere Medizin I
Freiburg im Breisgau
Heiko Becker, Prof. Dr. med.
- Recruiting
Onkologie Hannover
Hanover
Haytham Kamal, Dr. med.
- Recruiting
Onkologie Hof
Hof
Markus Kapp, Dr. med.
- Recruiting
Medizinisches Versorgungszentrum Mönchengladbach
Mönchengladbach
Ludger Sellmann, PD Dr. med.
- Recruiting
TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Innere Medizin II
München
Sebastian Lange, Dr. med.
- Recruiting
Onkologisches Zentrum Passau
Passau
Nikolay Malyshev, Dr. med.
- Recruiting
Gemeinschaftspraxis für Internistische Onkologie und Hämatologie
Rheine
Almut Berkemeier, Dr. med.
- Recruiting
RoMed Klinikum Rosenheim, Hämatologie und Onkologie
Rosenheim
Ulrike Kolar-Michaelis, Dr. med.
- Recruiting
ze:roPRAXEN MVZ für Innere Medizin
Weinheim
Manuel Zink, Dr. med.
About this study
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
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
- Medical subject headings
- Cholangiocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: max. 38 months (FPI - LPLV)
Secondary outcomes (25)
Overall survival (OS)
OS is defined as the time interval measured from the day of first ivosidenib administration to time of death from any cause. Time to last contact will be used if a patient has no documented date of death and OS for the patient will be considered censored.
Measured: max. 38 months (FPI - LPLV)
Timt to treatment failure (TTF)
TTF is defined as the time interval measured from the day of first ivosidenib until discontinuation of treatment for any reason including progression, toxicity, start of a new antineoplastic therapy, or death, whichever occurs first. Patients dropping out without knowledge of a potential ending of therapy (e.g., lost to follow up) will be censored with the last date of contact.
Measured: max. 38 months (FPI - LPLV)
Overall response rate (ORR)
ORR is defined as the proportion of patients achieving a complete or partial response as best response. Patients without response measurement are considered non-responders.
Measured: max. 38 months (FPI - LPLV)
Disease control rate (DCR)
DCR is defined as the proportion of patients achieving complete response, partial response, or stable disease as best response. Patients without response measurement are considered non-responders.
Measured: max. 38 months (FPI - LPLV)
(Serious) adverse events ((S)AE))
The case- and patient-based incidence of (S)AEs will be provided.
Measured: max. 38 months (FPI - LPLV)
(Serious) adverse drug reactions ((S)ADR) related to ivosidenib
The case- and patient-based incidence of (S)ADRs will be provided.
Measured: max. 38 months (FPI - LPLV)
Adverse events of special interest (AESI)
The case- and patient-based incidence of AESIs will be provided.
Measured: max. 38 months (FPI - LPLV)
Global health-related quality of life during course of treatment
The change from baseline (i.e., difference) in the scales of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer quality of life questionnaire C30) will be displayed for each point in time, using boxplots.
The scales of the EORTC QLQ-C30 range in score from 0 to 100. A high scale score represents a higher response level.
Measured: max. 38 months (FPI - LPLV)
Cholangiocarcinoma-related quality of life during course of treatment
The change from baseline (i.e., difference) in the scales of the EORTC QLQ-BIL21 (European Organisation for Research and Treatment of Cancer quality of life questionnaire BIL21) will be displayed for each point in time, using boxplots.
The scales of the EORTC QLQ-BIL21 range in score from 0 to 100. A high scale score represents a higher response level.
Measured: max. 38 months (FPI - LPLV)
Assessing parameters of physician treatment decision making
Frequencies of distinct impact ratings for parameters affecting ivosidenib therapy choice will be visualized using stacked bar charts.
Measured: max. 30 months (recruitment period)
Assessing parameters of physician treatment satisfaction
Frequencies of distinct satisfaction levels with ivosidenib treatment effectiveness and AE management will be visualized using stacked bar charts.
Measured: max. 32 months (recruitment period plus 8 weeks)
Cumulative ivosidenib dose
Summary tables containing descriptive statistics (n, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum) will be provided.
Measured: max. 38 months (FPI - LPLV)
Absolute dose intensity of ivosidenib
Summary tables containing descriptive statistics (n, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum) will be provided.
Measured: max. 38 months (FPI - LPLV)
Relative dose intensity of ivosidenib
Summary tables containing descriptive statistics (n, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum) will be provided.
Measured: max. 38 months (FPI - LPLV)
Frequency of dose modifications
Frequency of dose modifications will be presented.
Measured: max. 38 months (FPI - LPLV)
Type of dose modifications
Type of dose modifications (i.e., dose reductions, dose escalations, and interruptions) will be presented.
Measured: max. 38 months (FPI - LPLV)
Reasons for dose modifications
Reasons for dose modifications will be presented.
Measured: max. 38 months (FPI - LPLV)
Duration of treatment with ivosidenib
Duration of treatment with ivosidenib
Measured: max. 38 months (FPI - LPLV)
Reasons for end of treatment (EOT)
Reasons for end of treatment will be displayed
Measured: max. 38 months (FPI - LPLV)
Type of last previous therapy
Type of substances given in the last previous therapy will be displayed.
Measured: max. 38 months (FPI - LPLV)
Frequency of last previous therapy
Frequency of different substances given in the last previous therapy will be displayed.
Measured: max. 38 months (FPI - LPLV)
Duration of last previous therapy line
Duration of last previous therapy line will be displayed.
Measured: max. 38 months (FPI - LPLV)
Concomitant medications
Frequency of concomitant medications in total will be displayed.
Measured: max. 38 months (FPI - LPLV)
Concomitant medications known to induce QT prolongation
Frequency of concomitant medications known to induce QT prolongation (e.g., antiarrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) will be displayed.
Measured: max. 38 months (FPI - LPLV)
Subsequent antineoplastic therapies
Frequency and type of subsequent antineoplastic therapies by line of therapy will be displayed.
Measured: max. 38 months (FPI - LPLV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start8 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Servier Deutschland GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607302
- Sponsor's protocol ID
- iOM-040498
- Acronym
- IDHIRA
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40028796
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06607302
- Acronym / sponsor ID
- IDHIRA / iOM-040498
- Conditions
- Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Servier Deutschland GmbH
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival (PFS)
Time frame: max. 38 months (FPI - LPLV)
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.
25 secondary outcomes
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)
Absolute dose intensity of ivosidenib
Time frame: max. 38 months (FPI - LPLV)
Relative dose intensity of ivosidenib
Time frame: max. 38 months (FPI - LPLV)
Frequency of dose modifications
Time frame: max. 38 months (FPI - LPLV)
Type of dose modifications
Time frame: max. 38 months (FPI - LPLV)
Reasons for dose modifications
Time frame: max. 38 months (FPI - LPLV)
Duration of treatment with ivosidenib
Time frame: max. 38 months (FPI - LPLV)
Reasons for end of treatment (EOT)
Time frame: max. 38 months (FPI - LPLV)
Type of last previous therapy
Time frame: max. 38 months (FPI - LPLV)
Frequency of last previous therapy
Time frame: max. 38 months (FPI - LPLV)
Duration of last previous therapy line
Time frame: max. 38 months (FPI - LPLV)
Concomitant medications
Time frame: max. 38 months (FPI - LPLV)
Concomitant medications known to induce QT prolongation
Time frame: max. 38 months (FPI - LPLV)
Subsequent antineoplastic therapies
Time frame: max. 38 months (FPI - LPLV)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 40028796Michl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, run by iOMEDICO AG at 19 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sina Grebhardt, PhD (+49 761 15 242 31, sina.grebhardt@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: max. 38 months (FPI - LPLV)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06607302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.