Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor
About this trial
This is an interventional treatment trial for Urinary Bladder Neoplasms focused on measuring Non-Muscle-Invasive Bladder Cancer (NIMBC), Muscle-Invasive Bladder Cancer (MIBC)
Eligibility Criteria
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
Sites / Locations
- University of Southern CaliforniaRecruiting
- H. Lee Moffitt Cancer CenterRecruiting
- Northwestern UniversityRecruiting
- Levine Cancer Institute, Carolinas HealthCare SystemRecruiting
- Carolina Urologic Research CenterRecruiting
- Urology AssociatesRecruiting
- Urology San Antonio ResearchRecruiting
- Universitatsklinikum FrankfurtRecruiting
- Marien hospital HerneRecruiting
- Universitätsklinikum MünsterRecruiting
- Universitaetsklinikum UlmRecruiting
- National Cancer CenterRecruiting
- Chonnam National University HospitalRecruiting
- Seoul National University HospitalRecruiting
- The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
- Radboud Umcn
- UMC Utrecht
- Fundacion PuigvertRecruiting
- Hosp. Univ. Vall D HebronRecruiting
- Hosp. Clinic I Provincial de BarcelonaRecruiting
- Hosp. Univ. 12 de OctubreRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part 1: Dose Escalation
Part 2: Dose Expansion
Participants with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D[s]) for Part 2.
Participants in each of 5 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1.