C67 C66 C79 C68
Conditions
Interventions
Group 1: Assessment of the membranous NECTIN-4 expression and NECTIN-4 amplification in tumour tissue at baseline of Enfortumab Vedotin + Pembrolizumab treatment
Sponsors
Klinik und Poliklinik für Urologie und Kinderurologie, Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • The patient has been diagnosed with metastatic or inoperable urothelial carcinoma. • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 is available. • Treatment with enfortumab vedotin (EV) + pembrolizumab (PEM) combination therapy has been indicated. • Written documented consent to participate in the EVOKE trial has been obtained. • Histological material of the tumour tissue is available for examination
Exclusion criteria
Exclusion criteria: • The patient is unable to understand the scope, significance and consequences of this clinical trial • Participation in a trial with non-authorised medicinal products upon inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS1): Time from start of Enfortumab Vedotin + Pembrolizumab treatment until disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall response rate (ORR) according to RECIST v1.1 by investigator • Overall survival (OS) • PFS of first follow-up therapy after disease progression (PFS2) | — |
Countries
Germany
Contacts
Public ContactThomas Büttner
Klinik und Poliklinik für Urologie und Kinderurologie, Universitätsklinikum Bonn
Outcome results
None listed