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

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

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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.

Who Can Participate?

Eligibility

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 Range

18-110
Looking for Healthy Participants
No

What is Involved?

Description

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

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

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

Michael
Morse

Protocol Number

PRO00117957

NCT ID

NCT06501625

Phase

I/II

Enrollment Status

Pending Open to Enrollment