Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)

To evaluate the safety and efficacy of FE 999326 in Japanese subjects with high-grade, BCG unresponsive NMIBC.

Inclusion Criteria: * Have at entry, confirmed by a pathology report: 1. Carcinoma in situ (CIS) only 2. Ta/T1 high-grade disease with concomitant CIS or 3. Ta/T1 high-grade disease without concomitant CIS * Subjects who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. * Life expectancy \>2 years, in the opinion of the investigator * Eastern Cooperative Oncology Group (ECOG) status 2 or less * Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra * Subjects with prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) \