Expanded Access Program for Enfortumab Vedotin in Patients with Advanced Urothelial Cancer

Sponsor: Astellas Pharma Global Development, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04136808

Provider View

This program provides access to the drug enfortumab vedotin for patients in the U.S. with advanced urothelial cancer who have no other treatment options and cannot join ongoing clinical trials. The program aims to assess the safety and effectiveness of the drug.

Patient Parameters

Program Overview

This expanded access program is designed to offer the drug enfortumab vedotin (EV) to patients with advanced urothelial cancer who have already tried standard treatments without success and are not eligible for current clinical trials involving EV. The program will monitor the safety and effectiveness of EV in these patients.

Description

This program is available while a phase 3 study of enfortumab vedotin (EV) is ongoing for patients with advanced urothelial cancer who have already received treatment. It allows patients who have tried other treatments, including PD-1 or PD-L1 inhibitors and platinum-based chemotherapy, to access EV if no other standard treatments are available. Patients who have participated in previous EV studies or are eligible for ongoing EV trials cannot join this program. To enroll, a doctor must submit the patient's medical history to confirm eligibility.

The safety of EV will be monitored by checking for side effects, changes in health status, lab results, vital signs, and physical exams. Patients will receive the study medication until EV is approved by the FDA and available commercially or until the program ends.

Eligibility Criteria

Inclusion Criteria

  • Have advanced urothelial cancer that has worsened after previous treatment.
  • Have received platinum-based chemotherapy (cisplatin or carboplatin) and a PD-1 or PD-L1 inhibitor.
  • Have no other standard treatment options available.
  • Meet specific health criteria, including:
    • Neutrophil count of at least 1500/mm3
    • Platelet count of at least 75,000/mm3
    • Hemoglobin level of at least 8 g/dL
    • Normal liver and kidney function tests
  • Have an ECOG performance status of 0, 1, or 2.
  • Women must not be pregnant and agree to use birth control during and after treatment.
  • Men must agree to use birth control and not donate sperm during and after treatment.
  • Agree not to join other clinical studies while in this program.

Exclusion Criteria

  • Have ongoing nerve damage or significant side effects from previous treatments.
  • Have serious immune-related side effects requiring high doses of steroids.
  • Have previously received EV or participated in an EV study.
  • Are eligible for ongoing EV clinical trials.
  • Have allergies to EV or its ingredients.
  • Have had recent major surgery or cancer treatment.
  • Have uncontrolled diabetes or serious heart conditions.
  • Are currently being treated for infections with antibiotics or other medications.
  • Have other medical conditions that would prevent safe treatment with EV.

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