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
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 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.
Single group
Ivosidenib
DrugIvosidenib (daily 500 mg) maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma
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
recurrence-free survival
RFS, defined as time from start of ivosidenib maintenance to the date of disease recurrence or death to any cause
Time to recurrence
Time to recurrence (TTR), defined as time from start of ivosidenib maintenance to the date of disease recurrence
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
Overall survival
Overall survival (OS), defined as time from enrollment to the date of death from any cause
Click on the lead sponsor to view all of their trials.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
Servier Deutschland GmbH
Collaborator
Servier Affaires Médicales
Collaborator
