A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Inclusion Criteria

• •Histologically confirmed, non-muscle invasive urothelial carcinoma with carcinoma in situ (CIS) (with or without papillary disease)
• •Predominant histologic component (\>50 percent) must be urothelial (transitional cell) carcinoma
• •Participants must have high-risk Bacillus Calmette-Guerin (BCG) - unresponsive disease, defined as (where adequate BCG therapy is defined as one of the following: 5 of 6 doses of an initial induction course + at least 2 of 3 doses maintenance therapy or 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course):
• •* Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy.
• •* Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy, or
• •* T1 high-grade disease at the first evaluation following an induction BCG course (at least 5 or 6 doses)
• •Participant must be ineligible for or refusing a radical cystectomy
• •All visible papillary Ta/T1 tumors must be completely resected within 60 days prior to enrollment.
• •Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2.