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A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)

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Trial Profile

A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)

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

Latest Information Update: 05 Jul 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; Capecitabine; Cisplatin; Docetaxel; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms KEYNOTE-585; MK-3475-585/KEYNOTE-585
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

    • Most Recent Events

    • 29 May 2024 Trial design discussed in an abstract published in 60th Annual Meeting of the American Society of Clinical Oncology
    • 05 May 2024 Planned End Date changed from 28 Jun 2024 to 27 Jun 2025.
    • 20 Jan 2024 Interim results (at data cut off: 09 Feb 2023; n=203) assessing safety and efficacy analyses of the FLOT cohort, presented at the 2024 Gastrointestinal Cancers Symposium.

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