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NCT04223856 · ClinicalTrials.gov registry record · Phase 3
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
A Phase 3 study of Urothelial Cancer, sponsored by Astellas Pharma Global Development.
- Active
- Registry status
- Phase 3
- Development phase
- 886
- Enrollment target
- 20
- Study locations
NCT04223856 is a Phase 3 study of Urothelial Cancer that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 886 participants, above the 539-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (64% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT04223856, a Phase 3 study of Urothelial Cancer, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 886 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Enfortumab vedotin
Study Locations (20)
California
- Providence St Joseph Medical Center - Burbank
- City of Hope National Medical Center - Duarte
- University of California Los Angeles Medical Center - Los Angeles
- University of California Irvine - Newport - Orange
Colorado
- Rocky Mountain Cancer Centers - Aurora - Aurora
- University of Colorado Hospital / University of Colorado - Aurora
- Cancer Centers of Colorado - Denver - Denver
Arizona
- Ironwood Cancer & Research Centers - Chandler - Chandler
- Arizona Oncology Associates PD - HOPE - Tucson
Connecticut
- Yale Cancer Center - New Haven
- Eastern CT Hematology and Oncology Associates - Norwich
Georgia
- Winship Cancer Institute / Emory University School of Medicine - Atlanta
- Georgia Cancer Specialists / Northside Hospital Cancer Institute - Marietta
District of Columbia
- Lombardi Cancer Center / Georgetown University Medical Center - Washington D.C.
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Louisiana
- Louisiana State University/ East Jefferson General Hospital - Metairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 886 participants |
| Start Date | 2020-03-30 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04223856
The ClinicalTrials.gov registry entry for NCT04223856 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 886 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 539-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (64% higher). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Urothelial Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04223856 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT04223856 about?
NCT04223856 is a clinical study titled "Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer". 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 canc...
What is the current status of trial NCT04223856?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 886 participants. The study started on 2020-03-30. Estimated completion is 2028-03-01.
What conditions does trial NCT04223856 study?
This clinical trial studies the following conditions: Urothelial Cancer.
What interventions are being tested in trial NCT04223856?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT04223856?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04223856 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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