Universitaetsklinikum Ulm 89081 Ulm (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversity of Southern California 90033 Los Angeles United StatesRekrutierend» Google-MapsH. Lee Moffitt Cancer Center 33612 Tampa United StatesRekrutierend» Google-MapsNorthwestern University 60611 Chicago United StatesRekrutierend» Google-MapsLevine Cancer Institute, Carolinas HealthCare System 28204 Charlotte United StatesRekrutierend» Google-MapsCarolina Urologic Research Center 29572 Myrtle Beach United StatesRekrutierend» Google-MapsUrology Associates 37209 Nashville United StatesRekrutierend» Google-MapsUrology San Antonio Research 78229 San Antonio United StatesRekrutierend» Google-MapsNational Cancer Center 10408 Goyang-Si Korea, Republic ofRekrutierend» Google-MapsChonnam National University Hospital 61469 Gwangju Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsThe Catholic University of Korea Seoul St. Mary's Hospital 06591 Seoul Korea, Republic ofRekrutierend» Google-MapsRadboud Umcn 6525 GA Nijmegen NetherlandsAbgeschlossen» Google-MapsUMC Utrecht 3584 CX Utrecht NetherlandsAbgeschlossen» Google-MapsFund. Puigvert 08025 Barcelona SpainAbgeschlossen» Google-MapsHosp. Univ. Vall D Hebron 08035 Barcelona SpainRekrutierend» Google-MapsHosp. Clinic de Barcelona 08036 Barcelona SpainRekrutierend» Google-MapsHosp. Univ. 12 de Octubre 28041 Madrid SpainRekrutierend» Google-Maps
1. Number of Participants with Adverse Events (AEs) (Time Frame - Up to 5 years 3 months): An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
2. Number of Participants with AEs by Severity (Time Frame - Up to 5 years 3 months): Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
3. Number of Participants with Dose-limiting Toxicity (DLT) (Time Frame - Up to 28 days): Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Secondary outcome:
1. Plasma Concentration of Erdafitinib (Time Frame - Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks): Plasma concentration of Erdafitinib will be reported.
2. Urine Concentration of Erdafitinib (Time Frame - Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks): Urine concentration of Erdafitinib will be reported.
3. Cohorts 1 and 2: Recurrence-Free Survival (RFS) (Time Frame - Up to 5 years 3 months): RFS is defined as the time from start of treatment to the first detection of any new high-grade bladder cancer or upper tract urothelial carcinoma or positive urine cytology.
4. Cohort 3 and 5: Complete Response (CR) Rate (Time Frame - At 3 months): CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology.
5. Cohort 3 and 5: Duration of CR (Time Frame - Up to 5 years 3 months): Duration of CR is defined as the time from first documentation of CR until the date of documented recurrence or progression, or death, whichever comes first.
6. Cohort 4: Pathological Complete Response (pCR) Rate (Time Frame - Up to 8 weeks): pCR rate is defined as percentage of participants with no pathologic evidence of intravesical disease (pT0) and no pathologic evidence of nodal involvement (pN0).
7. Cohort 4: No Pathologic Evidence of Intravesical Disease (pT0) (Time Frame - Up to 8 weeks): pT0 rate is defined as percentage of participants with no Pathologic Evidence of Intravesical Disease.
8. Cohort 4: Rate of downstaging to Less than (<) pT2 (Time Frame - Up to 8 weeks): Rate of downstaging to <pT2 is defined as percentage of participants with pT stage <2.
Experimental: Part 1: Dose Escalation 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.
Experimental: Part 2: Dose Expansion 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.
Experimental: Part 3: RP2D Dose Expansion Participants in 2 of the disease-specific NMIBC cohorts (cohorts 1 and 3) may be enrolled at RP2D to determine the safety, evaluate PK and preliminary clinical activity.
