Overview

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

Status:
Recruiting

Trial end date:
2026-03-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Servier Bio-Innovation LLC

Collaborator:

Institut de Recherches Internationales Servier

Treatments:

Glycine
Ipilimumab
Ivosidenib
Nivolumab