A Phase 1b/2 Study of Ivosidenib With Durvalumab, Gemcitabine, and Cisplatin in People With Cholangiocarcinoma

Full Title

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

Purpose

Researchers want to learn if giving ivosidenib with other drugs is safe and works well in people with advanced cholangiocarcinoma. The people in this study have cholangiocarcinoma that has metastasized (spread) and is inoperable (cannot be removed with surgery). Their tumors have a mutation (change) in the IDH1 gene.

Ivosidenib blocks an abnormal form of the IDH1 protein. Abnormal IDH1 causes too much of a substance called 2-HG to be produced, which can fuel cancer growth.

If you take part in this study, you will take ivosidenib and also get durvalumab, gemcitabine, and cisplatin. Researchers will find the best dose of ivosidenib to give with the other medications. Ivosidenib is taken orally (by mouth). The other drugs are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

• Have metastatic inoperable cholangiocarcinoma with an IDH1 mutation.
• Have recovered from the serious side effects of prior anti-cancer therapies before getting the study therapy.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. James Harding’s office at 646-888-4314.