Ivosidenib for cholangiocarcinoma with an IDH1 mutation (S095031-210) - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if an experimental drug combination made up of ivosidenib, gemcitabine, cisplatin, and durvalumab is a safe and effective for treating cholangiocarcinoma.

¿Cuál es la Condición que se está estudiando?

Cholangiocarcinoma (Bile Duct Cancer)

¿Quién puede participar en el Estudio?

Adults ages 18+ who:

Are diagnosed with advanced or metastatic cholangiocarcinoma
Have a documented IDH1 mutation
Have not received any previous treatment for their cancer

For more information, contact the study team at dana.a.warren@duke.edu.

Grupo etario

Adultos

¿Qué Implica?

Si elige unirse a este estudio, podrá:

Take ivosidenib by mouth every day
Get intravenous (IV) infusions of gemcitabine and cisplatin every 1 to 2 weeks for the first 24 weeks
Get IV infusions of durvalumab every 3 to 4 weeks
Hacer extracciones de sangre y dar muestras de orina
Realice tomografías computarizadas o resonancias magnéticas de manera regular.

Detalles del Estudio

Título Completo

[S095031-210] A Phase 1b/2, Safety Lead-in and Dose-Expansion, Open label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination with Durvalumab and Gemcitabine/Cisplatin as First-line Therapy in Participants with Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma with an IDH1 Mutation

Investigador Principal