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A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)

Trial Profile

A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Feb 2019

At a glance

  • Drugs Pembrolizumab (Primary) ; Trastuzumab (Primary) ; Capecitabine; Cisplatin; Fluorouracil; Gimeracil/oteracil/tegafur; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE 811
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 01 Oct 2018 Planned initiation date (estimated date for recruitment of the first subject) changed from 7 Sep 2018 to 5 Oct 2018.
    • 20 Sep 2018 Planned End Date changed from 23 Dec 2023 to 20 Mar 2024.
    • 20 Sep 2018 Status changed from not yet recruiting to recruiting.
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