At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Compare the Efficacy and Safety of Tislelizumab (BGB-A317) Combined With Gemcitabine Plus Cisplatin Versus Placebo Combined With Gemcitabine Plus Cisplatin as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
In Brief
A Phase 3 clinical trial evaluating Tislelizumab, Placebo, and 2 other interventions for Recurrent or Metastatic Nasopharyngeal Cancer. Completed, enrolled 263 participants across 37 sites in 3 countries.
Detailed Summary
This study was designed to compare the efficacy and safety of tislelizumab (BGB-A317) combined with gemcitabine plus cisplatin versus placebo combined with gemcitabine plus cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal cancer.
Study Details
Timeline
Interventions
200 mg intravenously (IV) once every 3 weeks (Q3W)
Placebo to match tislelizumab (administered intravenously Q3W)
1 gram per square meter of body surface area (g/m\^2) on Day 1 and day 8 of each cycle, administered as an IV infusion within 30 minutes, for 4 to 6 cycles
80 milligrams per square meter of body surface area (mg/m\^2) on Day 1 of each cycle, administered as an IV infusion for over 4 hours if possible or with proper infusion time based on local clinical guidelines or clinical practice and according to the treating physician's clinical judgment, for 4 to 6 cycles.