NCT05921760

Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Servier Bio-Innovation LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2 study evaluating the safety, tolerability, and activity of ivosidenib in combination with immunotherapy in participants with nonresectable or metastatic cholangiocarcinoma. The study includes two phases: the safety lead-in phase to determine the recommended combination dose (RCD) of ivosidenib in combination with immunotherapy and the dose expansion phase to assess the efficacy of ivosidenib in combination with immunotherapy. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met. This study was terminated by the sponsor before the expansion phase began and therefore participants were only involved in the safety lead-in phase.

Conditions

• IDH1-mutant Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Ivosidenib	ivosidenib taken once daily
DRUG	Nivolumab	Nivolumab taken by intravenous infusion
DRUG	Ipilimumab	Ipilimumab taken by intravenous infusion

Timeline

• Start date: 2023-10-23
• Primary completion: 2024-11-21
• Completion: 2024-11-21
• First posted: 2023-06-27
• Last updated: 2026-04-20
• Results posted: 2026-02-12

Locations

5 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study