S095031-210 - Cholangiocarcinoma (Bile Duct Cancer)

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
ON HOLD