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
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