Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy
Public ClinicalTrials.gov record NCT04963153. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase Ib Trial of Erdafitinib Combined With Enfortumab Vedotin Following Prior Therapies for Metastatic Urothelial Carcinoma With FGFR2/3 Genetic Alterations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase Ib trial evaluates the best dose, potential benefits, and/or side effects of erdafitinib in combination with enfortumab vedotin in treating patients with bladder cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and possesses genetic alterations in FGFR2/3 genes. Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Giving erdafitinib in combination with enfortumab vedotin may shrink or stabilize metastatic bladder cancer with alterations in FGFR 2/3 genes.
Study identification
- NCT ID
- NCT04963153
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
- Locally Advanced Bladder Urothelial Carcinoma
- Locally Advanced Renal Pelvis Urothelial Carcinoma
- Locally Advanced Ureter Urothelial Carcinoma
- Locally Advanced Urethral Urothelial Carcinoma
- Locally Advanced Urothelial Carcinoma
- Metastatic Bladder Urothelial Carcinoma
- Metastatic Renal Pelvis Urothelial Carcinoma
- Metastatic Ureter Urothelial Carcinoma
- Metastatic Urethral Urothelial Carcinoma
- Metastatic Urothelial Carcinoma
- Recurrent Bladder Urothelial Carcinoma
- Recurrent Renal Pelvis Urothelial Carcinoma
- Recurrent Ureter Urothelial Carcinoma
- Recurrent Urethral Urothelial Carcinoma
- Recurrent Urothelial Carcinoma
- Stage IIIB Bladder Cancer AJCC v8
- Stage IV Bladder Cancer AJCC v8
- Stage IV Renal Pelvis Cancer AJCC v8
- Stage IV Ureter Cancer AJCC v8
- Stage IV Urethral Cancer AJCC v8
Interventions
- Biospecimen Collection Procedure
- Bone Scan Procedure
- Computed Tomography Procedure
- Echocardiography Test Procedure
- Enfortumab Vedotin Drug
- Erdafitinib Drug
- Multigated Acquisition Scan Procedure
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 6, 2022
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Jul 30, 2026
2022 – 2026
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04963153, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04963153 live on ClinicalTrials.gov.