Active — Not RecruitingPhase 2

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

United States20 participantsStarted 2022-02-17

Plain-language summary

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 participate

Age range18 Years

SexALL

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Inclusion Criteria: * Participants must have NMIBC that has come back after prior treatment (instillations of BCG or chemotherapy into the bladder). * Genetic testing of the participant's prior or recurrent NMIBC tumor will be performed to confirm the presence of an FGFR3 mutation * Patients must be able to walk and do routine activities for more than half of their normal waking hours. * This study is for people age 18 and older. * Willing and able to provide written informed consent for the trial. * Documentation on MSK-IMPACT of an oncogenic FGFR3 mutation (R248C, S249C, G370C, Y373C, etc.) or FGFR3 gene fusion with compelling clinical or biologic evidence in the OncoKB Precision Oncology Knowledge Base (https://oncokb.org/) from either archival NMIBC tumor tissue or recent TURBT/biopsy specimen of current tumor tissue. * Any recurrence of noninvasive-appearing papillary tumor(s) (clinical Ta disease) after at least 1 previous course of intravesical therapy with either: * (1) a history of a high-grade Ta tumor -OR- * (2) a history of low-grade T1 tumor -OR- * (3) low-grade Ta tumor with the new recurrent tumor demonstrating at least 1 additional "unfavorable" risk factor for future recurrence: * Multiple tumors * Tumor size ≥3 cm * Early recurrence ≤12 months from last treatment * Frequent recurrences ≥1 per year ° Given the frequent shortages of BCG, a prior course of therapy with either BCG therapy or intravesical chemotherapy (mitomycin, gemcitabine, etc.) is …

What they're measuring

Objective response rate

Timeframe: 3 weeks after first study treatment

Trial details

NCT IDNCT04917809

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08