[Translation] An open-label, randomized, controlled, phase III study of enfortumab vedotin plus pembrolizumab versus chemotherapy alone in patients with previously untreated locally advanced or metastatic urothelial carcinoma
该研究的主要目的是评估盲态独立中心审查(BICR) 评估的实验组(enfortumab vedotin+帕博利珠单抗[组A]) 比较对照组(吉西他滨+顺铂或卡铂[组 B])的无进展生存期(PFS),以及实验组(组A)比较对照组(组B)的总生存期(OS);
该研究也将评估基于BICR和/或研究者评估的实验组(组A)比较对照组 (组B)的客观缓解率(ORR)、缓解持续时间(DOR)、疾病控制率(DCR)和无进展生存期(PFS),以及从受试者角度评估治疗对生活质量(QOL)和疼痛等症状的影响,及各治疗方案的安全性特征。
[Translation] The primary objective of the study was to evaluate the blinded independent central review (BICR)-assessed experimental arm (enfortumab vedotin + pembrolizumab [arm A]) compared with the control arm (gemcitabine + cisplatin or carboplatin [arm B]) without Progression survival (PFS), and overall survival (OS) of the experimental group (group A) compared to the control group (group B);
The study will also evaluate objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and no Progression survival (PFS), as well as the impact of treatment on quality of life (QOL) and symptoms such as pain, and the safety profile of each treatment regimen from a subject's perspective.