治癒目的の手術を受けた新規子宮内膜癌患者を対象とした、放射線療法の有無にかかわらず補助化学療法とペムブロリズマブ（MK-3475）の併用療法に関する試験（MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053）

基本情報

NCT ID

NCT04634877

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

990

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.

対象疾患

介入

依頼者（Sponsor）

実施施設 (17)