胃癌または胃食道接合部（GEJ）腺癌患者を対象とした、ペンブロリズマブ（MK-3475）と化学療法の併用とプラセボと化学療法の併用を比較する試験（MK-3475-585/KEYNOTE-585）

基本情報

NCT ID

NCT03221426

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,007

治験依頼者名

Merck Sharp & Dohme LLC

概要

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. With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.

対象疾患

介入

依頼者（Sponsor）

実施施設 (29)