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An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

NCT04136808 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2020-01-13

No results posted yet for this study

Summary

The primary purpose of this expanded access program is to evaluate safety and tolerability of enfortumab vedotin (EV) in participants in the United States with locally advanced or metastatic urothelial carcinoma (UC) who have exhausted standard of care therapies and are not eligible to participate in an ongoing EV clinical study. This program will also evaluate the efficacy of EV.

Conditions

  • Locally Advanced or Metastatic Urothelial Carcinoma (UC)

Interventions

DRUG

enfortumab vedotin (EV)

Participants will receive an intravenously (IV) administered dose once weekly for the first 3 weeks of every 4-week cycle (i.e., on days 1, 8, and 15)

Sponsors & Collaborators

  • Seagen Inc.

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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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 NCT04136808 on ClinicalTrials.gov