A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer (NCT04917809)
A Phase 2 "Window of Opportunity" Trial of Targeted Therapy With Erdafitinib in Patients With Recurrent FGFR3-Altered Non-Muscle Invasive Bladder Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
- Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York
📞 Contact the Study Coordinator
Phone: (800) 525-2225
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Bladder Cancer
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- Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer — Calgary, Alberta
- Determinants of Bladder Cancer Recurrence Study (The DETER Study) — Basking Ridge, New Jersey
- Quality of Life in Patients With Bladder Cancer — New York, New York
- A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer — Hartford, Connecticut
- A Diagnostic for the Early Detection of Bladder Cancer — Long Beach, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.