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NCT03288545 · ClinicalTrials.gov registry record · Phase 1
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
A Phase 1 study of Urothelial Cancer and Urinary Bladder Neoplasms, sponsored by Astellas Pharma Global Development.
- Active
- Registry status
- Phase 1
- Development phase
- 348
- Enrollment target
- 20
- Study locations
NCT03288545: Active Phase 1 study of Urothelial Cancer and Urinary Bladder Neoplasms, sponsored by Astellas Pharma Global Development.
NCT03288545 is a Phase 1 study of Urothelial Cancer and Urinary Bladder Neoplasms that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 348 participants, below the 561-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03288545, a Phase 1 study of Urothelial Cancer and Urinary Bladder Neoplasms, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 348 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.
Primary Outcome
Descriptive statistics will be used to summarize results.
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG cisplatin
- DRUG carboplatin
- DRUG gemcitabine
- DRUG enfortumab vedotin (EV)
Study Locations (20)
California
- Tower Hematology Oncology Medical Group - Beverly Hills
- UC San Diego / Moores Cancer Center - La Jolla
- University of California Irvine - Newport - Orange
- University of California, Davis Comprehensive Cancer Center - Sacramento
- University of California at San Francisco - San Francisco
- Saint Joseph Heritage Medical Group - Santa Rosa
- Stanford Cancer Center / Blood & Marrow Transplant Program - Stanford
- Kaiser Permanente Southern California - Woodland Hills
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic Arizona - Phoenix
- Arizona Oncology Associates, PC - HOPE - Tucson
Colorado
- Rocky Mountain Cancer Centers - Aurora - Aurora
- University of Colorado Hospital / University of Colorado - Aurora
Connecticut
- Yale Cancer Center - New Haven
- Eastern CT Hematology and Oncology Associates - Norwich
Florida
- Boca Raton Regional Hospital / Lynn Cancer Institute - Boca Raton
- Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center - Fort Lauderdale
Alaska
- Alaska Urological Institute - Anchorage
Arkansas
- Highlands Oncology Group - Fayetteville
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2026-09-11 |
| Phase | Phase 1 |
What the registry record for NCT03288545 still lists
NCT03288545 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, below the 561-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (38% lower).
The record links to 7 conditions, with Urothelial Cancer appearing as the primary indexed condition, and to 5 interventions - of which pembrolizumab is the first listed.
NCT03288545 names 20 study sites across 8 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT03288545 about?
NCT03288545 is a clinical study titled "A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer". This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cance...
What is the current status of trial NCT03288545?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 348 participants. The study started on 2017-10-11. Estimated completion is 2026-09-11.
What conditions does trial NCT03288545 study?
This clinical trial studies the following conditions: Urothelial Cancer, Urinary Bladder Neoplasms, Urologic Neoplasms, Carcinoma, Transitional Cell, Ureteral Neoplasms.
What interventions are being tested in trial NCT03288545?
The interventions under investigation include: pembrolizumab (DRUG), cisplatin (DRUG), carboplatin (DRUG), gemcitabine (DRUG), enfortumab vedotin (EV) (DRUG).
Who is sponsoring clinical trial NCT03288545?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03288545 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03288545's enrollment target sits among peer trials
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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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