A Phase 1b/2, Safety Lead-in and Dose-Expansion, Open label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination with Durvalumab and Gemcitabine/Cisplatin as First-line Therapy in Participants with Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma with an IDH1 Mutation

Locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation

Safety Lead-in Phase: Dose-limiting toxicities (DLTs) associated with ivosidenib in combination with durvalumab and gemcitabine/ cisplatin as first-line therapy during the first cycle of treatment, Safety Lead-in Phase: Incidence and severity of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs), Safety Lead-in Phase: Dose reductions, delays, interruptions, and discontinuation., Expansion phase: Objective response (confirmed complete response ([CR] or confirmed partial response [PR]) of anti-tumor activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin as first-line therapy using RECIST v1.1

Safety Lead-in Phase: Ivosidenib plasma concentrations and PK parameters including, but not limited to: • Area under the concentration-versus-time curve (AUC) from time 0 to time of last measurable concentration (AUC0-t) • AUC over 1 dosing interval at steady state (AUCtau,ss) • Time to maximum concentration (Tmax) • Maximum concentration (Cmax) • Trough concentration (Ctrough) • Apparent volume of distribution (Vd/F) • Apparent clearance (CL/F), Safety Lead-in Phase: PD parameters including plasma 2-hydroxygluturate (2-HG) concentrations, Safety Lead-in Phase and Expansion Phase: Presence of ADAs for durvalumab (confirmatory results: positive or negative, titres), Expansion Phase: Incidence and severity of AEs, AESIs, and SAEs, Expansion Phase: Dose reductions, delays, interruptions, and discontinuation, Expansion Phase: Overall survival (OS), Expansion Phase: Duration of response (DOR), progression-free survival (PFS), disease control (i.e., confirmed CR, confirmed PR, or stable disease [SD]), and time to response (TTR) according to RECIST v1.1, Expansion Phase: Ivosidenib plasma concentrations and PK parameters including, but not limited to, AUC0-t, AUCtau,ss, Tmax, Cmax, Ctrough, Vd/F, and CL/F, Expansion Phase: Plasma 2-hydroxygluturate (2-HG) concentration

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