Clinical Trial

Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC

Study acronym: FIDELIO
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is a Phase 2 clinical intervention trial to assess efficacy of induction EVP to spare the bladder in stage T2-4aN0-1 urothelial bladder cancer (UBC), using a response-adapted approach
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-18.
Trial Details
NCT Number NCT07663747
Lead Sponsor The Netherlands Cancer Institute
Collaborators: Merck Sharp & Dohme LLC, Astellas Pharma Inc
Conditions Urothelial Bladder Cancer
Enrollment 56 participants
Start Date 2026-09-01
Primary Completion 2031-04-01 (estimated)
Study Completion 2032-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-25