A study comparing TAR-210 versus single agent treatment instilled directly into the bladder in people with bladder cancer with FGFR gene alterations.
Key facts
- Where
- A Coruña, Alzira, Barcelona, Cadiz, Castello De La Plana, Jerez de la Frontera, Madrid, Málaga, Pamplona, Sabadell és Valencia, SpanyolországSee the 13 sites
- Phase
- 3. fázis
Where in Spanyolország
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpanyolországTaking people
- Hospital Universitario de La RiberaAlzira, SpanyolországTaking people
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I SunyerBarcelona, SpanyolországTaking people
- Fundació PuigvertBarcelona, SpanyolországTaking people
- Hospital Universitario Puerta del MarCadiz, SpanyolországTaking people
- Hospital General Universitario De CastellonCastello De La Plana, SpanyolországTaking people
- Hospital de Jerez de la FronteraJerez de la Frontera, SpanyolországTaking people
- Clinica Universidad de NavarraMadrid, SpanyolországTaking people
- Hospital Universitario 12 de OctubreMadrid, SpanyolországTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpanyolországTaking people
- Clínica Universidad de navarraPamplona, SpanyolországTaking people
- Parc Tauli Hospital UniversitariSabadell, SpanyolországTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Cilag International
- Trial code
- EU 2023-507684-19-00
- Record updated
- 2026. október 26.
- Original description
To compare DFS between Group A and Group B.Read full original descriptionShow less
Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
To compare DFS between Group A and Group B.
Inclusion: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: • Ta LG/G1: primary or recurrent • Ta LG/G2: primary or recurrent And ≥1 of the following risk factors: • Multiple Ta LG tumors • Solitary LG tumor ≥3 cm • Early recurrence (≤1 year) • Frequent recurrence (>1 per year) • Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor) Note: Mixed histology tumors are allowed if percentage of variant histology and subtype of variant histology are consistent with an LG tumor; Have a susceptible FGFR mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing; Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy.
Exclusion: Histologically confirmed diagnosis of HR NMIBC (defined as HG/G2 or HG/G3 Ta and T1, or CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment; Has or had urothelial carcinoma outside of the urinary bladder (ie, urethra, ureter, or renal pelvis, N+, M+) or has a histological variant of UC. Ta/any T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study and without any evidence of disease following nephroureterectomy; Received an investigational treatment for bladder cancer after TURBT for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study; Received adjuvant intravesical chemotherapy within 6 months of current diagnosis. Peri-operative instillation of a single dose of intravesical chemotherapy per institutional guidelines (is not considered adjuvant therapy (and no washout period is required for this single dose); Received prior treatment with an FGFR inhibitor.