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

What is the Purpose of this Study?

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.

What is the Condition Being Studied?

Cholangiocarcinoma (Bile Duct Cancer)

Who Can Participate in the Study?

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.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

  • 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
  • Have blood draws and give urine samples
  • Have regular CT or MRI scans

Study Details

Full Title
[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
Principal Investigator
Headshot of Michael Aaron Morse
Professor of Medicine
Protocol Number
IRB: PRO00117957
NCT: NCT06501625
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL