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

Conditions

• IDH1-mutant Cholangiocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ivosidenib — DRUG
  ivosidenib taken once daily
• Nivolumab — DRUG
  Nivolumab taken by intravenous infusion
• Ipilimumab — DRUG
  Ipilimumab taken by intravenous infusion

Study Details

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.

Key Dates

Start date

Oct 23, 2023

Status verified

Mar 2026

Primary completion

Nov 21, 2024

Completion

Nov 21, 2024

Study Design

Enrollment

7 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Safety Lead-In Phase - Ivosidenib 500mg
• Experimental: Safety Lead-In Phase - Ivosidenib 250mg

Primary Outcome Measure

Safety Lead-In Phase: Number of Dose Limiting Toxicities (DLTs) Associated With Study Drug Regimen, During the First 2 Cycles of Treatment [ Time Frame: Through the end of Cycle 2, day 42 (Cycle 1 and 2 are each 21 days) ]

Locations (4)

Related coverage on Hipa.ai

• Trial results posted: NCT05921760
  Nivolumab · Feb 12, 2026 · ClinicalTrials.gov

Find similar trials in San Francisco, CA