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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
ivosidenib taken once daily
Nivolumab taken by intravenous infusion
Ipilimumab taken by intravenous infusion
UCSF - Medical Center at Mission Bay
San Francisco, California, United States
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
UCLH
London, United Kingdom
Safety Lead-In Phase: Number of Dose Limiting Toxicities (DLTs) Associated With Study Drug Regimen, During the First 2 Cycles of Treatment
Occurring during the safety lead-in phase
Time frame: Through the end of Cycle 2, day 42 (Cycle 1 and 2 are each 21 days)
Safety Lead-In Phase: Number of Adverse Events (AEs)
Occurring during the safety lead-in phase
Time frame: Through study termination (approximately 1 year)
Safety Lead-In Phase: Number of Participants With Adverse Events of Special Interests (AESIs)
Occurring during the safety lead-in phase
Time frame: Through study termination (approximately 1 year)
Safety Lead-In Phase: Number of Serious Adverse Events (SAEs)
Occurring during the safety lead-in phase
Time frame: Through study termination (approximately 1 year)
Safety Lead-In Phase: Area Under the Concentration-vs-time Curve (AUC) From 0 to Time of Last Measurable Concentration (AUC0-t)
Occurring during the safety lead-in phase
Time frame: Up to 3 years
Safety Lead-In Phase: Plasma 2-hydroxyglutarate (2-HG) Concentration
Occurring during the safety lead-in phase
Time frame: up to 3 years
Safety Lead-In Phase: AUC Over 1 Dosing Interval at Steady State (AUCtau,ss)
Occurring during the safety lead-in phase
Time frame: Up to 3 years
Safety Lead-In Phase: Time to Maximum Concentration (Tmax)
Occurring during the safety lead-in phase
Time frame: Up to 3 years
Safety Lead-In Phase: Maximum Concentration (Cmax)
Occurring during the safety lead-in phase
Time frame: Up to 3 years
Safety Lead-In Phase: Trough Concentration (Ctrough)
Occurring during the safety lead-in phase
Time frame: Up to 3 years
Safety Lead-In Phase: Apparent Volume of Distribution (Vd/F)
Occurring during the safety lead-in phase
Time frame: Up to 3 years
Safety Lead-In Phase: Apparent Clearance (CL/F)
Occurring during the safety lead-in phase
Time frame: Up to 3 years
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