Padcev (enfortumab vedotin-ejfv)

P1/2, N=428, Recruiting, Astellas Pharma Global Development, Inc. | Not yet recruiting --> Recruiting

P2, N=34, Active, not recruiting, University of Utah | Recruiting --> Active, not recruiting

P2, N=100, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.

Survey-based opinions can effectively capture treatment selection preferences for mUC and could inform future clinical trial design. Additional data, including the impact of residual toxicity from 1L EVP, are needed to better understand real-world treatment sequencing patterns.

P1, N=32, Recruiting, Emory University | Trial primary completion date: Dec 2025 --> Nov 2026

P1/2, N=272, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

P2, N=68, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting

These findings confirm that testicular CHC expresses Nectin-4 and may be potentially targetable with EV. Future studies are needed to verify whether metastasis and chemotherapy up-regulate Nectin-4 and increase the sensitivity to EV, and whether the absence of Nectin-4 expression by cytotrophoblasts (the proliferative population of CHC) influences its potential efficacy.

P2, N=12, Not yet recruiting, William Bradley | Initiation date: Nov 2025 --> Apr 2026

Minimal tumor uptake is observed in blocking and Nectin4-negative controls, confirming specificity. Complementary fluorescence imaging further reveals the in vivo distribution of Padcev, providing valuable insights into optimal therapeutic time windows.

Accordingly, gemcitabine-cisplatin with nivolumab and platinum-based chemotherapy followed by maintenance avelumab remain validated evidence-based alternatives, particularly for cisplatin-eligible patients or in regions where enfortumab vedotin plus pembrolizumab is not readily accessible...Enfortumab vedotin monotherapy retains activity post-platinum and immune checkpoint inhibition, erdafitinib provides a targeted benefit in fibroblast growth factor receptor 3-altered tumors, and trastuzumab deruxtecan has emerged as a later-line option for HER2-positive disease. In parallel, circulating tumor DNA is an emerging biomarker with potential to individualize sequencing strategies, although its clinical application remains investigational. This review synthesizes current evidence and highlights practical considerations, emphasizing the need to balance therapeutic innovation with cost effectiveness, equitable access, and global applicability, while identifying critical research priorities in the post-enfortumab vedotin plus pembrolizumab era.

P2, N=27, Recruiting, National Cancer Center, Japan