Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    1000
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 30 May 2021
fluorouracil
metastasis
oxaliplatin
capecitabine
pembrolizumab
leucovorin
docetaxel
cancer chemotherapy
adenocarcinoma
solid tumour
mk-3475
immunostimulants

Summary

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

The primary study hypotheses are that:

  • Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
  • Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.

Details
Condition Gastropathy, Gastric Cancer, Stomach Discomfort, Gastroesophageal Junction Cancer, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Capecitabine, cisplatin, docetaxel, Placebo, Pembrolizumab, Oxaliplatin, Leucovorin, 5-fluorouracil
Clinical Study IdentifierNCT03221426
SponsorMerck Sharp & Dohme Corp.
Last Modified on30 May 2021

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