Tests TAR-210 Against Standard Bladder Medicine Treatment For Bladder Cancer
Compares TAR-210 with standard chemotherapy given into the bladder in adults with bladder cancer.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
Key facts
- Where
- Arezzo, Bergamo, Brescia, Milan, Romagnano, Rozzano, and Torino, ItalySee the 9 sites
- Phase
- Phase 3
Where in Italy
- Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia MedicaArezzo, ItalyTaking people
- Cliniche Humanitas GavazzeniBergamo, ItalyTaking people
- ASST Spedali Civili BresciaBrescia, ItalyTaking people
- Istituto Dei Tumori Di MilanoMilan, ItalyTaking people
- Ospedale San RaffaeleMilan, ItalyNo longer taking part
- Istituto Nazionale Tumori Regina ElenaRomagnano, ItalyTaking people
- Universita Campus Bio-Medico di RomaRomagnano, ItalyTaking people
- Istituto Clinico HumanitasRozzano, ItalyTaking people
- A.O.Citta della Salute e della Scienza di TorinoTorino, ItalyTaking 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 Research & Development, LLC
- Trial code
- NCT06319820
- Record updated
- 3 November 2026
- Original description
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.Read full original descriptionShow less
A 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
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
Inclusion: Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor >= 3 cm, iii. Early recurrence (less than [<] 1 year), iv. Frequent recurrence (greater than [>] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor); Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and >=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor >=3 cm; Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing; Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm; Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy; Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment; Have an Eastern Cooperative Oncology Group performance status of 0 to 2.
Exclusion: Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy; Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery); Substudy:; Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis; Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs; Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL); Current indwelling urinary catheters, however, intermittent catheterization is acceptable.