Comparing Futibatinib Plus Zimberelimab With Gemcitabine and Cisplatin Versus Durvalumab or Pembrolizumab Combined With Gemcitabine and Cisplatin in First-Line Advanced Biliary Tract Cancer

What this Trial Is About

Researchers are comparing overall survival in patients with advanced biliary tract cancer receiving different treatment combinations. This phase 3 international study evaluates Futibatinib and Zimberelimab combined with Gemcitabine plus Cisplatin against Durvalumab or Pembrolizumab combined with Gemcitabine plus Cisplatin as first-line therapy for these patients. The study aims to assess which treatment approach may provide better outcomes for this advanced cancer type. Participants will be assigned to one of two groups one receiving Futibatinib orally once daily together with Zimberelimab by intravenous infusion every three weeks, plus Gemcitabine and Cisplatin given intravenously on Days 1 and 8 of each three-week cycle the other group will receive either Durvalumab or Pembrolizumab by intravenous infusion every three weeks alongside Gemcitabine and Cisplatin on the same schedule. Treatments continue with these cycles as per study protocol. During the study, participants will be regularly assessed for overall survival up to approximately 45 months. Additional evaluations include progression-free survival, tumor response rates, duration of response, and monitoring of adverse events. These assessments will be conducted through imaging, biomarker analysis, and clinical examinations to understand treatment effects and safety over time.

Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer