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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)

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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)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Mar 2025

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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 Corp.

Most Recent Events

  • 08 Nov 2024 Planned End Date changed from 30 Dec 2024 to 17 Sep 2025.
  • 14 Sep 2024 According to a Merck & Co media release, in the U.S., KEYTRUDA, in combination with trastuzumab and chemotherapy, is indicated under accelerated approval for first-line treatment in the subset of this patient population whose tumors express PD-L1 (Combined Positive Score [CPS] greater than equal to 1), based on prior KEYNOTE-811 results.
  • 14 Sep 2024 According to a Merck & Co media release, results from this trial presented today during a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2024 (Presentation #1400O) and are also being simultaneously published in the New England Journal of Medicine.

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