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A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

Trial Profile

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Apr 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Cisplatin; Gemcitabine
  • Indications Biliary cancer; Carcinoma; Cholangiocarcinoma; Gallbladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-966
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 23 Apr 2025 Status changed from active, no longer recruiting to completed.
    • 19 Sep 2024 Planned End Date changed from 29 Nov 2024 to 1 Apr 2025.
    • 04 Jun 2024 Results reporting updated efficacy and safety data after 11 months of additional follow-up presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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