A phase III, single-arm study to evaluate the efficacy and safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) administered intravesically to patients with BCG unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease

BCG-unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease

CRR calculated as the proportion of patients achieving a CR at any time. CRR will be based on central assessment of response. Local assessments will be used by Investigators to decide on whether to start the maintenance phase, while the statistical analysis of the efficacy endpoints will be performed on central assessments.

1. CRR calculated as the proportion of patients achieving a CR at EOIT/EORIT, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction start., 2. DoR defined as the time from first documented evidence of CR to time of documented recurrence (CIS or HG Ta-T1), progression to MIBC, to extravesical disease or death., 3. DoR rate calculated as the proportion of patients who maintained a CR after 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction start., 4. Progression rate calculated as the proportion of patients with tumor progression to MIBC or extravesical disease at EOIT/EORIT, 15, 24 and 48 months after induction or re-induction start., 5. Time to progression defined as time from treatment start to time of documented tumor progression to MIBC or extravesical disease., 6. Proportion of patients undergoing cystectomy for disease progression at EOIT/EORIT, 9, 15, 24 and 48 months after induction or re-induction start., 7. Time to cystectomy defined as time from start of treatment to the date of cystectomy., 8. EFS defined as time from treatment start to the time of documented recurrence after CR, or progression or death due to any cause., 9. OS defined as time from treatment start to death due to any cause.

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