A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
Trial Status: active
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 Criteria
- 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)
- 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 Criteria
- 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
- 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
- Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL)
- Current indwelling urinary catheters, however, intermittent catheterization is acceptable
- 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)
Additional locations may be listed on ClinicalTrials.gov for NCT06319820.
Locations matching your search criteria
United States
California
Los Angeles
Los Angeles General Medical Center
Status: Temporarily closed to accrual
Contact: Xiomara Menendez
Phone: 323-865-0212
Email: menendez_x@med.usc.edu
USC / Norris Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Xiomara Menendez
Phone: 323-865-0212
Email: menendez_x@med.usc.edu
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not AvailableColorado
Aurora
UCHealth University of Colorado Hospital
Status: Active
Contact: Robyn Swing
Phone: 720-848-0607
Email: robyn.swing@cuanschutz.edu
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not AvailableIllinois
Chicago
Northwestern University
Status: Active
Name Not AvailableMassachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not AvailableMichigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not AvailableNew Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not AvailableNew York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableNorth Carolina
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Status: Active
Name Not AvailableTexas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationJanssen Pharmaceuticals
- Primary ID42756493BLC3004
- Secondary IDsNCI-2024-03808, 2023-507684-19
- ClinicalTrials.gov IDNCT06319820