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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

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 04 Feb 2025

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At a glance

  • Drugs Tislelizumab (Primary) ; Cisplatin; Gemcitabine
  • Indications Nasopharyngeal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RATIONALE 309
  • Sponsors BeiGene

    • Most Recent Events

    • 01 Sep 2024 Results assessing health-related quality of life, published in the Head and Neck journal.
    • 16 Jul 2024 Status changed from active, no longer recruiting to completed.
    • 30 May 2024 Planned End Date changed from 1 Jun 2024 to 1 Jun 2025.

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