Brief Title: Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants with Adverse Events (AEs)

Primary Outcome 1 - Timeframe: Up to 5 years 3 months

Primary Outcome 2 - Measure: Number of Participants with AEs by Severity

Primary Outcome 2 - Timeframe: Up to 5 years 3 months

Primary Outcome 3 - Measure: Number of Participants with Dose-limiting Toxicity (DLT)

Primary Outcome 3 - Timeframe: Up to 28 days

CONDITION

• Urinary Bladder Neoplasms
• Receptors
• Fibroblast Growth Factor

ELIGIBILITY

Inclusion Criteria:
Recurrent, non-muscle-invasive or muscle-invasive urothelial carcinoma of the Bladder

- Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment: Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests

- Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible.

- Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)

- Cohorts 2 and 4: Willing and eligible for RC
Exclusion Criteria:
Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium

- Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor

- Received pelvic radiotherapy <=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis

- Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system

- Indwelling urinary catheter. Intermittent catheterization is acceptable

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Janssen Research & Development, LLC Clinical Trial

Phone: 844-434-4210

Email: Participate-In-This-Study@its.jnj.com

LOCATION