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CholangiocarcinomaPhase 2adIVONCT07260175

Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma

A Phase 2 study testing Ivosidenib in people with Cholangiocarcinoma and IDH Mutation, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 15 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study trial is a prospective, multicentre, exploratory, single-arm, open-label phase II study to evaluat ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma, IDH Mutation
What is being tested?
Ivosidenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
15 sitesGermany
Study dates
18 Nov 2025to Dec 2031
Phase
Phase 2
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

Who may be able to join

  • Patient* provides signed informed consent.
  • Patient is ≥ 18 years at the time of given informed consent.
  • Patient has histologically documented curatively resected intrahepatic cholangiocarcinoma, without metastatic spread, in the adjuvant situation (R0-resected)
  • Patient has proven IDH1 mutation (IDH1-variant status evaluated locally by certified test on formalin-fixed paraffin-embedded tumor tissue specimen. If local testing for screening is not possible per local standard, tumor tissue samples will be subject to pre-screening via central IDH1 dPCR)
  • Patient finished adjuvant systemic SOC chemotherapy (with regimens allowed per the protocol) directly prior to trial inclusion.
  • Radiologic imaging available that shows that patient is tumor free at the timepoint of enrollment (not older than 6 weeks from the day of inclusion).
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  • Patient has ECOG Performance status ≤ 1
  • Hematological, hepatic and renal function parameters adequate to allow targeted therapy with ivosidenib at investigator´s discretion and IB.
  • Patient has adequate coagulability to allow targeted therapy with ivosidenib at investigator´s discretion and IB. Patients receiving warfarin / Phenprocoumon must be switched to low molecular weight heparin and before starting trial-specific.
  • Patient must be willingly to provide liquid biopsy samples, archival tumor tissue samples (if available), and in the event of disease recurrence, re-biopsy samples (if re-biopsy is considered safe for the patient) for the translational research program.
  • Female patients of childbearing potential or male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of trial treatment. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy.
  • Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the trial including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • Patient has a metastatic or R+ resected biliary tract cancer.
  • Patient received previous therapy with an IDH1 inhibitor.
  • Patient has known presence of tumors other than intrahepatic cholangiocarcinoma or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years.
  • Simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone therapy not described in the trial protocol.
  • Patient receives simultaneous treatment with a different anti-cancer therapy other than that provided for in the trial (excluding palliative radiotherapy only for symptom control).
  • Patient has a stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis.
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  • Patient has known allergic / hypersensitive reactions to at least one of the treatment components.
  • Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the trial.
  • Patient has a known presence of an active, uncontrollable infection.
  • Patient has QTc > 480ms or other factors that, in the discretion of the investigator increase significantly the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT syndrome). NOTE: Medications that prolong the QT interval should be avoided, unless they can be transferred to other medication within ≥ 5 half-lives to dosing or unless the medications can be properly monitored during the study. (If equivalent medication is not available, QTc should be closely monitored).
  • Patient has active disseminated intravascular coagulation.
  • Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug.
  • Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect. NOTE: strong CYP3A4 inducers or sensitive CYP3A4 substrates with narrow therapeutic window should be avoided, unless they can be transferred to alternative medication within at least 5-half lives prior to dosing.
  • Female patient is pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment.
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Thorsten Götze, Prof. Dr. contact

+49 69 76 01 ext. 4187

Goetze.Thorsten@KHNW.DE

Johanna Riedel, Dr. contact

+49 69 5899 787 ext. 57

riedel.johanna@ikf-khnw.de

15 sites in 1 country

Germany15 sites, 15 recruiting

  • Uniklinik RWTH Aachen

    Aachen, 52074

    Marie-Luise Berres, Prof. Dr.

    Recruiting

  • Universitätsklinikum Bonn

    Bonn, 53127

    Maria Gonzalez-Carmona, Prof. Dr.

    Recruiting

  • Uniklinikum Essen

    Essen, 45147

    Stefan Kasper-Virchow, Prof. Dr.

    Recruiting

  • Krankenhaus Nordwest

    Frankfurt, 60488

    Thorsten O Goetze, Prof. Dr.

    Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

    Jörg Trojan, Prof. Dr.

    Recruiting

  • Universitätsklinik Gießen und Marburg GmbH Standort Gießen

    Giessen, 35392

    Thomas Wehler, Prof. Dr.

    Recruiting

  • Universitätsmedizin Göttingen

    Göttingen, 37099

    Johanna Reinecke, Dr.

    Recruiting

  • Asklepios Tumorzentrum Hamburg

    Hamburg, 22763

    Dirk Arnold, Prof.

    Recruiting

  • Uniklinikum Jena

    Jena, 7747

    Udo Lindig, Dr.

    Recruiting

  • Universitätsmedizin Mainz

    Mainz, 55131

    Arndt Weinmann, Prof. Dr.

    Recruiting

  • Universitätsklinikum Mannheim

    Mannheim, 68167

    Nadine Schulte, Dr.

    Recruiting

  • LMU Klinikum Großhadern

    München, 81377

    Danmei Zhang, Dr. med.

    Recruiting

  • Klinikum rechts der Isar TU München

    München, 81675

    Patrick Wenzel, Dr.

    Recruiting

  • Klinikum Oldenburg AöR

    Oldenburg, 26133

    Andrea Renzelmann, Dr.

    Recruiting

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg, 93049

    Anke Schlenska-Lange, Dr.

    Recruiting

Other trials in Germany

About this study

Official title: adIVO - A Phase II Trial of Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma

This study trial is a prospective, multicentre, exploratory, single-arm, open-label phase II study to evaluat ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma

Read the detailed description

The primary objective is to assess the efficacy of ivosidenib maintenance directly after adjuvant SOC chemotherapy in curative mIDH1 iCCA. The corresponding endpoint ist 1-year recurrence-free survival rate (RFS@1year), defined as proportion of patients alive with no disease recurrence 1 year after start of maintenance ivosidenib.

The secondary objective is to evaluate further efficacy as well as to assess safety and impact on the quality of life of ivosidenib maintenance directly after adjuvant SOC chemotherapy in curative mIDH1 iCCA. The corresponding endpoint are:

  • RFS, defined as time from start of ivosidenib maintenance to the date of disease recurrence or death to any cause
  • Time to recurrence (TTR), defined as time from start of ivosidenib maintenance to the date of disease recurrence
  • Time to treatment failure (TTF), defined as time from start of ivosidenib maintenance to the date of premature treatment discontinuation from any cause, including disease recurrence, treatment toxicity or death
  • Overall survival (OS), defined as time from enrollment to the date of death from any cause
  • Safety
  • Quality of life using EORTC QLQ-C30 and EORTC QLQ-BIL21 questionnaires

This is a prospective, multi-center, exploratory, single-arm, open-label phase II study.

Patients with curatively resected intrahepatic cholangiocarcinoma with proven IDH1 mutation, without metastatic spread, in the adjuvant situation (R0-resected), who received 6 months of SOC adjuvant treatment and show at least stable disease under this treatment will be enrolled.

All eligible patients will receive ivosidenib (500 mg qd, 28 days). Patients will be treated within the trial for up to 12 months and the treatment response will be assessed every 8 weeks (Q8W ± 7 days) during trial treatment and every 12 weeks (Q12W ± 14 days) during follow-up until recurrence. Overall, patients will be followed up for 48 months after last patient in or until death, withdrawal of consent, or loss to follow-up (whichever occurs first).

Being tested
Ivosidenib
Keywords
mIDH1 cholangiocarcinoma, ivosidenib maintenance, cholangiocarcinoma, R0-resection
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvosidenibDrug

    Also called Ivosidenib Pill (daily 500 mg)

    Ivosidenib (daily 500 mg) maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma

Study groups in NCT07260175
Study groupRoleWhat they receive
Ivosidenib maintenanceExperimentalIvosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma
Receives: Drug: Ivosidenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recurrence-free survival rate

    1-year recurrence-free survival rate (RFS@1year), defined as proportion of patients alive with no disease recurrence 1 year after start of maintenance ivosidenib

    Measured: 1-year

Secondary outcomes (7)

  1. recurrence-free survival

    RFS, defined as time from start of ivosidenib maintenance to the date of disease recurrence or death to any cause

    Measured: at 66 months

  2. Time to recurrence

    Time to recurrence (TTR), defined as time from start of ivosidenib maintenance to the date of disease recurrence

    Measured: after 66 months

  3. Time to treatment failure (TTF)

    Time to treatment failure (TTF), defined as time from start of ivosidenib maintenance to the date of premature treatment discontinuation from any cause, including disease recurrence, treatment toxicity or death

    Measured: at 66 months

  4. Overall survival

    Overall survival (OS), defined as time from enrollment to the date of death from any cause

    Measured: at 66 months

  5. Safety (adverse events)

    frequency of adverse events

    Measured: at 66 months

  6. Patient´s Quality of life

    Quality of life using EORTC QLQ-C30

    Measured: at 66 months

  7. Patient´s Quality of Life

    Quality of life using EORTC QLQ-BIL21

    Measured: at 66 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start18 Nov 2025
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07260175
Sponsor's protocol ID
adIVO
Other IDs
2024-520219-42-00, AIO-HEP-0125/ass., IKF-081
Acronym
adIVO
Status last verified
Nov 2025
First submitted
2 Oct 2025
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivosidenib in people with Cholangiocarcinoma and IDH Mutation, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 15 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 12 inclusion and 16 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Thorsten Götze, Prof. Dr. (+49 69 76 01 ext. 4187, Goetze.Thorsten@KHNW.DE), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recurrence-free survival rate (time frame: 1-year). 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 NCT07260175.

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 12 Aug 2026.

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