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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: Active Phase 3 study of Urothelial Cancer, sponsored by Astellas Pharma Global Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of
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 |
What the registry record for NCT04223856 still lists
NCT04223856 is an interventional study that assigns participants to a tested intervention. The registered 886 participants enrollment target is mid-sized for trials with a published cap, above the 539-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (64% higher).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04223856's enrollment target sits among peer trials
886 5th of 25 higher than 21 of 25 other Urothelial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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