RecruitingPhase 2NCT07260175

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

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


Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

40 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ivosidenib — a targeted oral drug that blocks a mutated enzyme called IDH1 — taken after surgery and standard chemotherapy can prevent bile duct cancer (cholangiocarcinoma) from coming back in patients whose tumors were successfully removed. **You may be eligible if...** - You are 18 or older - You have been diagnosed with intrahepatic cholangiocarcinoma (bile duct cancer inside the liver) that was completely removed with surgery (R0 resection), with no spread to other organs - Your tumor has a confirmed IDH1 mutation - You have completed or are finishing standard post-surgery chemotherapy **You may NOT be eligible if...** - Your tumor does not have the IDH1 mutation - Your cancer has spread to other parts of the body - Surgery did not fully remove the tumor - You have significant liver, heart, or other organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvosidenib

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


Locations(8)

Uniklinik RWTH Aachen

Aachen, Germany

Universitätsklinikum Bonn

Bonn, Germany

Krankenhaus Nordwest

Frankfurt, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Universitätsmedizin Göttingen

Göttingen, Germany

Uniklinikum Jena

Jena, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

Klinikum rechts der Isar TU München

München, Germany

View Full Details on ClinicalTrials.gov

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NCT07260175


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