Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology \[SUO\] Guideline (2020)
Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
* Recurrence within 1 year, low-grade Ta
* Solitary low-grade Ta \>3 cm
* Low-grade Ta, multifocal
* Solitary high-grade Ta, ≤3 cm
* Low-grade T1
* Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.
* Restage TURBT may be done at the discretion of the investigator
You may not be if
Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
High risk NMIBC defined as:
High-grade T1
Any recurrent, high-grade Ta
High-grade Ta \>3 cm (or multifocal)
Any carcinoma in situ (CIS)
Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
Any variant histology
Any prostatic urethral involvement
Low risk NMIBC defined as:
First occurrence of low-grade solitary Ta ≤3 cm
Recurrence of low-grade solitary Ta ≤3 cm \>12 months from previous occurrence
Papillary urothelial neoplasm of low malignant potential
