進行頭頸部扁平上皮癌に対する手術前投与および手術後投与放射線療法との併用におけるペンブロリズマブの研究（MK-3475-689）

基本情報

NCT ID

NCT03765918

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

714

治験依頼者名

Merck Sharp & Dohme LLC

概要

This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

対象疾患

介入

依頼者（Sponsor）

実施施設 (10)