E-VIRTUE: a study of enfortumab vedotin with or without pembrolizumab in rare genitourinary tumors—design and rationale

作者：Elias Chandran, Saad Atiq, Nicholas I. Simon, Daniel M. Girardi, Lisa Ley, Lisa M. Cordes, Ruchi P. Patel, Tzu-Fang Wang, Andre R. Kydd, Bernadette Redd, Salah Boudjadi, Ian Stukes, Rouf Banday, Elizabeth Smith, Dilara Akbulut, Scot A. Niglio, Sandeep Gurram, Seth M. Steinberg, Andrea B. Apolo · 发表于：Future Oncology · 年份：2025 · DOI：10.1080/14796694.2025.2497719 · 被引用次数：3 · 研究领域：Ovarian cancer diagnosis and treatment、Genital Health and Disease、Colorectal and Anal Carcinomas

Enfortumab vedotin (EV) is an antibody-drug conjugate targeting nectin-4 with a monomethyl auristatin E payload, a potent microtubule inhibitor. It is a standard of care in metastatic or locally advanced urothelial carcinoma in combination with pembrolizumab in the first line, and as monotherapy post-chemotherapy and post-anti-PD-1/PD-L1 therapy. This article describes the design and rationale behind E-VIRTUE, an open-label phase 2 trial of EV with or without pembrolizumab in locally advanced or metastatic urinary tract pure adenocarcinoma or urachal adenocarcinoma, pure squamous cell carcinoma and treatment-refractory germ cell tumors. As these rare genitourinary tumors lack an established standard of care and published literature suggests nectin-4 expression, we hypothesize that EV with or without pembrolizumab will be effective in them.Clinical Trial Registration NCT06041503 (ClinicalTrials.gov).