Bladder Neoplasm Clinical Trial
Official title:
A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be
conducted in approximately 120 investigational sites worldwide. Subjects with either
recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for
participation in this study.
Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1,
and/or CIS) at least 6 months from the start of a full induction course of BCG with or
without maintenance/re-treatment at 3 months.
Recurrent disease is defined as reappearance of disease after achieving a tumor-free status
by 6 months following a full induction course of BCG with or without maintenance/re-treatment
at 3 months. Subjects with recurrent disease must have recurred within 18 months following
the last dose of BCG.
Approximately 450 subjects will be randomized. The primary objective of this study is to
evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment of
subjects with recurrent or refractory NMIBC. The secondary objective is to evaluate the
safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent
or refractory NMIBC. This study will consist of 4 phases: Screening, Induction, Maintenance
and Follow-Up and will be conducted over 3 years.
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