This is a Phase II clinical study to evaluate the efficacy and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate/high-risk NMIBC.
In Cohort A, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which is unresponsive to BCG treatment. In Cohort B, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (Ta/T1 papillary without CIS) which is unresponsive to BCG treatment. In Cohort C, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which has previously been exposed to BCG and is unresponsive to chemotherapy treatment. In Cohort D, participants will be enrolled with pathologically confirmed intermediate/high-risk non-muscle invasive bladder cancer (NMIBC) (Ta/T1 papillary without CIS) which has previously been exposed to BCG and is unresponsive to chemotherapy treatment. In all cohorts, study treatment will be administered as a weekly induction course for the first 6 weeks. For high-risk participants, a reinduction course administered to participants who have residual CIS or high-grade Ta disease at the 3-month evaluation. Following induction, If the tumor assessment indicates CR or no recurrence the participant enters the maintenance phase, T3011 is administered once every 3 weeks (Q3W). For intermediate-risk participants, a reinduction course administered to participants who have low-grade Ta disease at the 3-month evaluation. Following induction, the participant achieving no recurrence (e.g., no tumor) enters the maintenance phase, T3011 is administered once every 3 weeks (Q3W). Disease status will be assessed using cystoscopy, urine cytology, histopathology (if performed), and imaging examinations (if performed) every 3 months during treatment period or until disease recurrence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
T3011 will be administered at a dose of 1x10\^10 PFU intravesically.
East Valley Urology Center
Queen Creek, Arizona, United States
NOT_YET_RECRUITINGFlorida Urology Partners, LLP
Tampa, Florida, United States
RECRUITINGComplete Response Rate in patients with CIS
Time frame: 3,6,12 months time point from the date of the first dose of T3011
Recurrence Free Survival Rate in patients with Ta/T1 (without CIS)
Time frame: 3,6,12 months time point from the date of the first dose of T3011
Incidence rates of Grade ≥3 treatment-related adverse events (TRAEs)
Time frame: 24 months
Incidence rates of TRAEs leading to treatment discontinuation, dose modification or treatment interruption.
Time frame: 24 months
Complete Response Rate in patients with CIS
Time frame: 18,24 months time point from the date of the first dose of T3011
Recurrence Free Survival Rate in patients with Ta/T1 (without CIS)
Time frame: 18,24 months time point from the date of the first dose of T3011
Safety Endpoints
* Incidence rates of Grade ≥3 treatment-emergent adverse events (TEAEs) * Incidence rates of all grades of TRAEs * Incidence rates of AEs leading to treatment discontinuation, dose modification or treatment interruption
Time frame: 24 months
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