Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

  • STATUS
    Recruiting
  • End date
    Mar 20, 2024
  • participants needed
    732
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 11 August 2021
cancer
measurable disease
fluorouracil
metastasis
oxaliplatin
capecitabine
immunohistochemistry
pembrolizumab
HER2
EGFR
trastuzumab
gastric cancer
human epidermal growth factor
cancer chemotherapy
adenocarcinoma
solid tumour
erbb2
mk-3475
tegafur
gimeracil

Summary

The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).

Description

Pembrolizumab (200 mg) or placebo will be administered intravenously [IV] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy for the global cohort will either be FP (80 mg/m^2 cisplatin administered IV on Day 1 of each 3-week cycle and 800 mg/m^2 5-fluorouracil [5-FU] administered IV on Days 1-5 of each 3-week cycle) or CAPOX (1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week cycle). A Japan cohort will receive SOX chemotherapy consisting of S-1 (tegafur, 5-chloro-2,4-dihydroxypyridine [CDHP], and potassium oxonate [Oxo]) administered orally BID according to Body Surface Area (BSA) on Days 1-14 of each 3-week cycle and oxaliplatin (130 mg/m^2) administered IV on Day 1 each 3-week cycle.

Details
Condition Gastropathy, Gastric Cancer, Stomach Discomfort, Gastroesophageal Junction Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Stomach Cancer, gastric neoplasm, gastric tumor
Treatment Capecitabine, cisplatin, Placebo, Trastuzumab, Pembrolizumab, S-1, Oxaliplatin, 5-FU
Clinical Study IdentifierNCT03615326
SponsorMerck Sharp & Dohme Corp.
Last Modified on11 August 2021

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