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Clinical Trials in the EU / 2026-525965-29-00
Authorised, not yet recruiting Phase II

A phase 2 study to assess efficacy of induction Enfortumab Vedotin plus Pembrolizumab using a response-adapted approach to spare the bladder: FIDELIO

2026-525965-29-00 · tracked via the Priya Life Science EU tracker
Sponsor
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Neoplasms
Decision date
05/10/2026
Enrollment target
56
Sites
Netherlands

Condition studied

Adult patients with cT2-4aN0-1 urothelial bladder cancer, who are amenable for a bladder-sparing approach, will be included. Patients must have a WHO performance status 0 or 1

Investigational medicinal product(s)

KEYTRUDA 25 mg/mL concentrate for solution for infusion.Padcev 30 mg powder for concentrate for solution for infusion

Every trial of Enfortumab Vedotin and Pembrolizumab across our registers →

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Estimated 2-year bladder-intact event-free survival (BI-EFS) for the intention-to-treat population, measured from day 1 of treatment until the moment of analysis.

Endpoint detail

Feasibility of no consolidation vs consolidative RT (followed by maintenance pembrolizumab) in cCR patients after induction EVP: rate of cystectomy and/or muscle-invasive recurrence per arm, Overall survival (OS), Progression-free survival (PFS), Metastasis-free survival (MFS), Bladder function of no consolidation vs consolidative RT in cCR patients after induction EVP using bladder-specific QOL assessments., Muscle-invasive recurrence in patients not undergoing cystectomy, Non-muscle-invasive bladder recurrence in patients not undergoing cystectomy, Safety of EVP induction by NCI CTC-AE 5.0 criteria, Prediction of BI-EFS by circulating tumor DNA (ctDNA) assessment

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-525965-29-00 on CTIS ↗ ← All trials in the EU