A randomized, prospective, phase II study to determine the efficacy of BCG given in combination with panvac versus BCG alone in adults with high grade non-muscle invasive bladder cancer who failed at least one induction course of BCG.

TPS4590 Background: High grade non-muscle invasive bladder cancer (NMIBC) has a 70% recurrence rate and rate of 15-30% progression. The standard of care is an induction course of bacillus Calmette-Guerin (BCG). A second induction course can be used in patients who fail the initial course, however only 35% of patients will experience a 12 month disease free survival. For those patients failing a second induction course, radical cystectomy is the gold standard treatment, although the morbidity rate is high. Therefore there is an unmet need for localized treatment for patients who fail an initial induction course of BCG. Recently, a pox viral vector-based vaccine, PANVAC, has been shown to induce a CD4 and CD8 antigen-specific immune response against the tumor-associated antigens, carcinoembryonic antigen (CEA) and mucin-1 (MUC-1). This vaccine also contains transgenes for three human T cell co-stimulatory molecules that can potentially augment an immune response. We hypothesize that the combined administrat...