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

Phase 1/2 Terminated NCT05921760

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.

Safety Lead-In Phase: Number of Dose Limiting Toxicities (DLTs) Associated With Study Drug Regimen, During the First 2 Cycles of Treatment

Through the end of Cycle 2, day 42 (Cycle 1 and 2 are each 21 days) · DLT events

Safety Lead-In Phase: Number of Adverse Events (AEs)

Through study termination (approximately 1 year) · events

Safety Lead-In Phase: Number of Participants With Adverse Events of Special Interests (AESIs)

Through study termination (approximately 1 year) · Participants

Open in BENITIONS View on ClinicalTrials.gov

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