A phase 2 study to assess efficacy of induction Enfortumab Vedotin plus Pembrolizumab using a response-adapted approach to spare the bladder: FIDELIO
Sponsor: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Phase: 2
Disease: Muscle-invasive urothelial carcinoma of the bladder
EU trial number: 2026-525965-29-00
Population: Adults with previously untreated, histologically confirmed cT2-4aN0-1M0 muscle-invasive urothelial bladder cancer who seek an alternative to radical cystectomy or are medically unfit for surgery, are suitable for a bladder-sparing approach, and have WHO performance status 0-1.
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