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Active, not recruiting Phase 2 Interventional

A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer

ClinicalTrials.gov ID: NCT04917809

Public ClinicalTrials.gov record NCT04917809. 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.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 8:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2 "Window of Opportunity" Trial of Targeted Therapy With Erdafitinib in Patients With Recurrent FGFR3-Altered Non-Muscle Invasive Bladder Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the effectiveness of erdafitinib in people with non-muscle invasive bladder cancer (NMIBC) that has come back after standard treatment, such as Bacillus Calmette-Guerin (BCG) or chemotherapy instilled into the bladder. Participants in this study will have bladder cancer with a mutation in the FGFR3 gene. FGFR3 mutations are the most common genetic alteration in NMIBC and is present in the majority of recurrent NMIBC tumors. Genetic testing of the participant's prior or recurrent NMIBC tumor will be performed to confirm it has an FGFR3 gene mutation. Erdafitinib is a pill given orally (by mouth) that blocks the protein made by this altered gene, which may stop cancer cells from growing. Erdafitinib is already used as an approved treatment for metastatic bladder cancer. Researchers are doing this study to determine whether erdafitinib is an effective treatment for FGFR3-altered non-muscle invasive bladder cancer in the time period between when a recurrent tumor is identified and a TURBT (transurethral resection of a bladder tumor) or biopsy procedure is performed to remove it.

Study identification

NCT ID
NCT04917809
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
20 participants

Conditions and interventions

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
Feb 16, 2022
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027
Last update posted
Sep 1, 2026

2022 – 2027

United States locations

U.S. sites
7
U.S. states
2
U.S. cities
7
Facility City State ZIP Site status
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey 07920
Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey 07645
Memorial Sloan Kettering Commack (Limited Protocol Activities) Commack New York 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale New York 11553

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04917809, 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 Sep 1, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04917809 live on ClinicalTrials.gov.

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