๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-27

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (NCT04223856)

An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Astellas Pharma Global Development, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

Who can join: Review the eligibility criteria below.

Location: Ironwood Cancer & Research Centers - Chandler โ€” Chandler, Arizona

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (260 Sites)

Showing the first 25 of 260 sites.

  • Ironwood Cancer & Research Centers - Chandler โ€” Chandler, Arizona
  • Arizona Oncology Associates PD - HOPE โ€” Tucson, Arizona
  • Providence St Joseph Medical Center โ€” Burbank, California
  • City of Hope National Medical Center โ€” Duarte, California
  • University of California Los Angeles Medical Center โ€” Los Angeles, California
  • University of California Irvine - Newport โ€” Orange, California
  • Rocky Mountain Cancer Centers - Aurora โ€” Aurora, Colorado
  • University of Colorado Hospital / University of Colorado โ€” Aurora, Colorado
  • Cancer Centers of Colorado - Denver โ€” Denver, Colorado
  • Yale Cancer Center โ€” New Haven, Connecticut
  • Eastern CT Hematology and Oncology Associates โ€” Norwich, Connecticut
  • Lombardi Cancer Center / Georgetown University Medical Center โ€” Washington D.C., District of Columbia
  • H. Lee Moffitt Cancer Center and Research Institute โ€” Tampa, Florida
  • Winship Cancer Institute / Emory University School of Medicine โ€” Atlanta, Georgia
  • Georgia Cancer Specialists / Northside Hospital Cancer Institute โ€” Marietta, Georgia
  • Louisiana State University/ East Jefferson General Hospital โ€” Metairie, Louisiana
  • Maine Health Cancer Care โ€” Biddeford, Maine
  • Johns Hopkins Medical Center โ€” Baltimore, Maryland
  • Comprehensive Cancer Centers of Nevada โ€” Las Vegas, Nevada
  • New Mexico Cancer Center โ€” Albuquerque, New Mexico
  • New York University (NYU) Cancer Institute โ€” New York, New York
  • Mount Sinai Medical Center โ€” New York, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Vidant Medical Center โ€” Greenville, North Carolina
  • The Cleveland Clinic โ€” Cleveland, Ohio

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—