Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Inclusion Criteria: * Have a histopathological confirmed diagnosis consistent with locally advanced unresectable or metastatic cholangiocarcinoma. * Have documented IDH1 gene-mutated cholangiocarcinoma based on local or central laboratory testing (R132C/L/G/H/S mutation variants tested). * Have at least one evaluable and measurable lesion as defined by RECIST v1.1. * Have adequate bone marrow function as evidenced by: * Absolute neutrophil count ≥ 1,500/mm3 or 1.5 ×109/L * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 100,000/mm3 or 100 × 109/L * Have adequate hepatic function as evidenced by: * Serum bilirubin ≤ 2.0 × the upper limit of normal (ULN); this will not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction should be resolved before randomization * Aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤ 5.0 × ULN * Have adequate renal function, defined as: creatinine clearance \> 60 mL/min per 24 hour urine or as calculated on the Cockcroft-Gault formula (using actual body weight): Creatine CL (mL/min)= (140 - Age) × (weight in kg) × (0.85 if female)/72 × serum creatinine (mg/dL) Exclusion Criteria: * Received treatment for locally advanced, unresectable or metastatic disease with the following exceptions: * Treatment with up to one cycle of durvalumab plus gemcitabine/cisplatin treatment is permitted before study participation. Note: For the Saf…