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

August 11, 2026 updated by: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • Uniklinik RWTH Aachen
        • Contact:
          • Marie-Luise Berres, Prof. Dr.
      • Bonn, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn
        • Contact:
          • Maria Gonzalez-Carmona, Prof. Dr.
      • Essen, Germany, 45147
        • Recruiting
        • Uniklinikum Essen
        • Contact:
          • Stefan Kasper-Virchow, Prof. Dr.
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt
        • Contact:
          • Jörg Trojan, Prof. Dr.
      • Frankfurt, Germany, 60488
        • Recruiting
        • Krankenhaus Nordwest
        • Contact:
          • Thorsten O Goetze, Prof. Dr.
      • Giessen, Germany, 35392
        • Recruiting
        • Universitätsklinik Gießen und Marburg GmbH Standort Gießen
        • Contact:
          • Thomas Wehler, Prof. Dr.
      • Göttingen, Germany, 37099
        • Recruiting
        • Universitätsmedizin Göttingen
        • Contact:
          • Johanna Reinecke, Dr.
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Tumorzentrum Hamburg
        • Contact:
          • Dirk Arnold, Prof.
      • Jena, Germany, 7747
        • Recruiting
        • Uniklinikum Jena
        • Contact:
          • Udo Lindig, Dr.
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin Mainz
        • Contact:
          • Arndt Weinmann, Prof. Dr.
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsklinikum Mannheim
        • Contact:
          • Nadine Schulte, Dr.
      • München, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar TU München
        • Contact:
          • Patrick Wenzel, Dr.
      • München, Germany, 81377
        • Recruiting
        • LMU Klinikum Großhadern
        • Contact:
          • Danmei Zhang, Dr. med.
      • Oldenburg, Germany, 26133
        • Recruiting
        • Klinikum Oldenburg AöR
        • Contact:
          • Andrea Renzelmann, Dr.
      • Regensburg, Germany, 93049
        • Recruiting
        • Krankenhaus Barmherzige Brüder Regensburg
        • Contact:
          • Anke Schlenska-Lange, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient* provides signed informed consent.
  2. Patient is ≥ 18 years at the time of given informed consent.
  3. Patient has histologically documented curatively resected intrahepatic cholangiocarcinoma, without metastatic spread, in the adjuvant situation (R0-resected)
  4. 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)
  5. Patient finished adjuvant systemic SOC chemotherapy (with regimens allowed per the protocol) directly prior to trial inclusion.
  6. 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).
  7. Patient has ECOG Performance status ≤ 1
  8. Hematological, hepatic and renal function parameters adequate to allow targeted therapy with ivosidenib at investigator´s discretion and IB.
  9. 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.
  10. 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.
  11. 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.
  12. 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.

Exclusion Criteria:

  1. Patient has a metastatic or R+ resected biliary tract cancer.
  2. Patient received previous therapy with an IDH1 inhibitor.
  3. 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.
  4. Simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone therapy not described in the trial protocol.
  5. 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).
  6. 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.
  7. Patient has known allergic / hypersensitive reactions to at least one of the treatment components.
  8. Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the trial.
  9. Patient has a known presence of an active, uncontrollable infection.
  10. 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).
  11. Patient has active disseminated intravascular coagulation.
  12. 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.
  13. 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.
  14. 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.
  15. Female patient is pregnant or breast feeding or planning to become pregnant within and 6 months after the end of treatment.
  16. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ivosidenib maintenance
Ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma
Drug: Ivosidenib
Ivosidenib (daily 500 mg) maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma
Other Names:
  • Ivosidenib Pill (daily 500 mg)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
recurrence-free survival rate
Time Frame: 1-year
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
1-year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
recurrence-free survival
Time Frame: at 66 months
RFS, defined as time from start of ivosidenib maintenance to the date of disease recurrence or death to any cause
at 66 months
Time to recurrence
Time Frame: after 66 months
Time to recurrence (TTR), defined as time from start of ivosidenib maintenance to the date of disease recurrence
after 66 months
Time to treatment failure (TTF)
Time Frame: at 66 months
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
at 66 months
Overall survival
Time Frame: at 66 months
Overall survival (OS), defined as time from enrollment to the date of death from any cause
at 66 months
Safety (adverse events)
Time Frame: at 66 months
frequency of adverse events
at 66 months
Patient´s Quality of life
Time Frame: at 66 months
Quality of life using EORTC QLQ-C30
at 66 months
Patient´s Quality of Life
Time Frame: at 66 months
Quality of life using EORTC QLQ-BIL21
at 66 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Servier Deutschland GmbH
Servier Affaires Médicales

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thorsten Götze, Prof. Dr., Krankenhaus Nordwest GmbH
  • Study Director: Salah Al-Batran, Prof. Dr., Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • adIVO
  • 2024-520219-42-00 (Ctis)
  • AIO-HEP-0125/ass. (Other Identifier: AIO)
  • IKF-081 (Other Identifier: Frankfurter Institut für Klinische Krebsforschung IKF GmbH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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