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A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
NCT03288545 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03288545
The ClinicalTrials.gov registry entry for NCT03288545 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 348 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03288545 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03288545?
This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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