Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)

Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost.

Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.

Acetaminophen or equivalent medications per institutional standard may be administered at the discretion of the investigator.

Antihistamine (e.g., diphenhydramine) or equivalent medications per institutional standard may be administered at the discretion of the investigator.

Bladder biopsy at screening and every 3 months before each cystoscopy per schema.

Transurethral resection of a bladder tumor (TURBT) at screening and every 3 months before each cystoscopy per schema.

Urine cytology at screening and every 3 months before each cystoscopy per schema.

Urine cytology at baseline and every 3 months before each cystoscopy per schema.

Electrocardiogram (ECG) at screening, pre-durvalumb infusion and as clinically indicated during the trial.

Computed tomography (CT) at screening and every 12 months while on study.

Magnetic resonance imaging (MRI) at screening and every 12 months while on study.