局所進行性または転移性尿路上皮癌の治療歴を有する患者におけるエンフォルツマブベドチンと化学療法の比較試験（EV-301）

基本情報

NCT ID

NCT03474107

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

608

治験依頼者名

Astellas Pharma Inc

概要

The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

対象疾患

介入

依頼者（Sponsor）