NCT03924986

Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent or Metastatic Nasopharyngeal Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 mg intravenously (IV) once every 3 weeks (Q3W)
DRUG	Placebo	Placebo to match tislelizumab (administered intravenously Q3W)
DRUG	Gemcitabine	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
DRUG	Cisplatin	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.

Timeline

• Start date: 2019-03-27
• Primary completion: 2021-03-26
• Completion: 2023-12-08
• First posted: 2019-04-23
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

37 sites across 3 countries: China, Taiwan, Thailand