Study Detail

CRITERIA

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

• Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC)
• Locally documented history of histologically confirmed low-grade Ta NMIBC
• Must have visible tumor by cystoscopy within 12 weeks prior to first dose
• Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:
• Multiple tumors
• >1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
• Early recurrence (<1 year) of the initial diagnosis of low-grade disease
• Solitary tumor >3 cm
• Failure of prior intravesical treatment
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

• Newly diagnosed low-grade nonmuscle invasive bladder cancer (Ta NMIBC)
• Has active total bladder incontinence, active urinary tract infection (UTI), neurogenic bladder, or urethral stricture
• Past or current history of high-grade (Ta or T1or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention