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

NCT05921760 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-04-20

Study results available
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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

DRUG

Ivosidenib

ivosidenib taken once daily

DRUG

Nivolumab

Nivolumab taken by intravenous infusion

DRUG

Ipilimumab

Ipilimumab taken by intravenous infusion

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    collaborator OTHER

  • Servier Bio-Innovation LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2024-11-21
Completion
2024-11-21
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05921760 on ClinicalTrials.gov