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$SESN The trial included 133 patients, who were places into 1 of 3 cohorts: patients with carcinoma in situ with or without papillary disease that was refractory or the patient had recurred within 6 months of adequate BCG treatment; patients with carcinoma in situ with or without papillary disease that recurred between 6 and 11 months of BCG treatment; and patients with papillary disease only that recurred within 6 months of BCG treatment.

The study design consisted of a screening period, a 12-week induction phase, and a maintenance phase of up to 21 cycles of treatment, for a total of 104 weeks of treatment. Vicineum at 30 mg in 50 mL of saline was instilled into the bladder 2 hours on a schedule of 2 times per week for 6 weeks in the induction phase, followed by weekly for 6 weeks followed by every 2 weeks for up to 2 years as the maintenance phase. The coprimary end points of the trial are CR rate and the duration of response (DOR) in the first cohort.