An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects with Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517571-20-00

Acronym

7465-CL-0301

Enrollment

Registered

2024-10-24

Start date

2018-09-07

Completion date

2025-11-27

Last updated

2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic urothelial cancer

Brief summary

Overall survival

Detailed description

PFS1 by RECIST V1.1, ORR (CR + PR) by RECIST V1.1, DCR (CR + PR + SD) by RECIST V1.1, DOR by RECIST V1.1, Safety variables (e.g., AEs, laboratory tests, vital sign measurements, 12-lead ECG and ECOG PS), QOL and PRO parameters (QLQ-C30 and EQ-5D-5L)

Interventions

DRUGenfortumab vedotin

DRUGVINFLUNINE

DRUGDOCETAXEL

DRUGPACLITAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
PFS1 by RECIST V1.1, ORR (CR + PR) by RECIST V1.1, DCR (CR + PR + SD) by RECIST V1.1, DOR by RECIST V1.1, Safety variables (e.g., AEs, laboratory tests, vital sign measurements, 12-lead ECG and ECOG PS), QOL and PRO parameters (QLQ-C30 and EQ-5D-5L)	—

Countries

Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026