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A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

NCT03474107 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2026-01-09

Study results available
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Summary

The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.

This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy.

In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

Conditions

Interventions

DRUG

Enfortumab Vedotin

Intravenous infusion

DRUG

Docetaxel

Intravenous infusion

DRUG

Vinflunine

Intravenous infusion

DRUG

Paclitaxel

Intravenous infusion

Sponsors & Collaborators

  • Seagen Inc.

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2020-07-15
Completion
2025-11-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03474107 on ClinicalTrials.gov