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)
• 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)
• Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
• Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or corneal disease that prevents and/or delays corneal healing
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron’s disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Known additional malignancy that is progressing or has required active treatment within the past 3 years
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.