CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)

Inclusion Criteria: * Clinical diagnosis of NMIBC based on cystoscopic appearance * ECOG 0-2 * No intravesical therapy within 6 weeks of study entry * No prior radiation to the pelvis * ANC \>1500/mm³; Hb \>9.0 g/dL; Platelet \>100000/mm³ * Serum creatinine ≤ 1.5 mg/dL * Bilirubin within normal limits; AST ≤ 2.5x upper limit of normal (ULN); ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5x ULN unless bone metastasis is present in the absence of liver metastasis * INR \< 1.2; aPPT = 0.8-1.2; PT = 0.9-1.8 * Candidate for TUR and planning to undergo TUR * Negative pregnancy test within 7 days of treatment start * Patients of child-bearing potential must agree to use an effective method of birth control Exclusion Criteria: * Prior local or systemic treatments for NMIBC * Concurrent treatment with any chemotherapeutic agent * Patients not deemed acceptable for general anaesthesia * Women who are pregnant or lactating * History of vesicoureteric reflux or an indwelling urinary stent * Administration of an investigational agent within 3 months of study entry * Active cardiac disease * Known infection with HIV, hepatitis B or C * Active uncontrolled infection