切除されたLA頭頸部扁平上皮癌、高リスク、シスプラチン不適応患者における第III相試験ゼビナパント（デビオ1143）と放射線療法（XRAY VISION）

基本情報

NCT ID

NCT05386550

ステータス

中止

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

166

治験依頼者名

EMD Serono

概要

The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

対象疾患

介入

依頼者（Sponsor）

実施施設 (22)