Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects with Nonresectable
Research type
Research Study
Full title
A Phase 1/2, Safety Lead-in and Dose Expansion, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination with Nivolumab and Ipilimumab in Previously Treated Subjects with Nonresectable or Metastatic Cholangiocarcinoma with an IDH1 Mutation
IRAS ID
1008456
Contact name
Julia Crepineau
Contact email
Sponsor organisation
Institut de Recherches Internationales Servier (I.R.I.S.)
Eudract number
2023-503236-41
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine the safety, best dose, and effectiveness of ivosidenib in combination with nivolumab and ipilimumab for treating patients with cholangiocarcinoma (CCA) (also known as bile duct cancer) with an IDH1 mutation that has not responded to other treatments, and that cannot be removed with surgery (unresectable) or has spread to other places in the body (metastatic).
This study is divided into 2 phases: Safety Lead-in (SLI) Phase and Expansion Phase. The SLI Phase is the first part of the study. Patients included in SLI Phase will not participate in the Expansion Phase.
The main purpose of the SLI Phase is to evaluate the safety of ivosidenib in combination with nivolumab and ipilimumab. The SLI Phase will also determine the recommended combination dose of ivosidenib, nivolumab, and ipilimumab. During the SLI Phase, patients will receive a dose of 500 mg or 250 mg of ivosidenib once a day, plus 3 milligrams per kilogram of body weight (mg/kg) of nivolumab by infusion through a vein (intravenous [IV] infusion) and 1 mg/kg of ipilimumab by IV infusion once every 3 weeks for 4 doses, followed by 480 mg of nivolumab by IV once every 4 weeks until the disease gets worse (called “disease progression”). Patients will receive a maximum of 2 years of treatment with nivolumab. Visits will be scheduled at the hospital throughout the patient's participation in this study.
Participants will be asked not to take any other medications without the agreement of the research doctor or to participate in another clinical trial.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0965
Date of REC Opinion
10 Jan 2024
REC opinion
Further Information Favourable Opinion