A study comparing TAR-210 versus single agent treatment instilled directly into the bladder in people with bladder cancer with FGFR gene alterations.
- Conditions
- FGFR+ Intermediate-risk Non-muscle Invasive Bladder CancerTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507684-19-00
- Lead Sponsor
- Janssen Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 540
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: recurrent •Ta LG/G1: primary and multifocal, or primary and =3 cm •Ta G2: primary or recurrent And =1 of the following risk factors: •Multiple Ta LG tumors •Solitary LG tumor >3 cm •Early recurrence (within 1 year) •Frequent recurrence (>1 per year) •Recurrence after prior intravesical chemotherapy Note: Mixed histology tumors are allowed if urothelial differentiation is predominant., 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. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method).
Histologically confirmed diagnosis of HR NMIBC (any HG [G3] Ta or 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 induction intravesical chemotherapy within 6 months of current diagnosis. Peri-operative instillation of a single dose of intravesical chemotherapy is allowed per institutional guidelines (No washout period is required for this single dose)., Received prior intravesical treatment with immunotherapy including BCG within 2 years prior to randomization., Received prior treatment with an FGFR inhibitor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method