A randomized placebo-controlled phase II study with the cancer vaccine candidate IGN101 in patients with epithelial cancers

2555 Background: IGN101 is a vaccine designed for therapeutic vaccination against cancers of epithelial origin. It consists of 0.5 mg alum-adsorbed murine monoclonal antibody 17-1A as vaccine antigen to trigger an immune response and has been shown in phase I to reduce the number of circulating EpCAM-positive tumor cells. Methods: A 1:1 prospective randomized double-blind placebo-controlled phase II trial was conducted in 240 patients (pts) with epithelial cancers Stage III or IV. Objectives were to assess effects of IGN101 on survival of the whole study population but also to analyse in an exploratory way the survival effects for the different tested indications. Primary endpoint was overall survival (OS), secondary endpoints included safety, tolerability and immunogenicity. Vaccinations with IGN101 or placebo (alum) were given on days 1, 15, 29 and 57 and in weeks 16, 24, 32, 40 and 68. Concomitant standard therapies were permitted. Pts were recruited from Sept. 01 until July 03. Results: On intention-t...