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

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).