This is a phase III, single-arm, multicenter, international study to assess the efficacy and
safety of ONCOFID-P-B following intravesical instillation in adult patients with
histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are
unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy.
After providing written informed consent (in presence of an Independent Witness, if
applicable), patients will receive an induction therapy consisting of 12 weekly intravesical
instillations of ONCOFID-P-B (induction phase). Patients who achieve a CR by Investigator
assessment at the end of the induction phase will enter the maintenance phase and receive
monthly treatment for an additional 12 months or until recurrence of CIS/Ta-T1 or progression
to MIBC or extravesical disease.