Clinical Trials

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/23/2026. Questions regarding updates should be directed to the study team contact.