高リスク皮膚扁平上皮癌患者における手術および放射線療法後の補助療法としてのセミプリマブとプラセボの比較研究

基本情報

NCT ID

NCT03969004

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

415

治験依頼者名

Regeneron Pharmaceuticals

概要

The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum

対象疾患

介入

依頼者（Sponsor）

実施施設 (6)