DERMA phase III trial of MAGE-A3 antigen-specific cancer immunotherapeutic (ASCI) as adjuvant therapy in patients with MAGE-A3-positive resected stage III melanoma.

TPS232 Background: Clinical activity of the MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) was observed in a Phase II study in patients with metastatic melanoma (NCT00086866) and in a Phase II study in patients with completely resected non-small cell lung cancer (NSCLC) (NCT00290355). Based on these positive signals for the activity of MAGE-A3 ASCI, a Phase III trial is currently ongoing in patients with resectable regionally advanced melanoma (DERMA Phase III trial, NCT00796445). Methods: DERMA is a double-blind, placebo-controlled, 2:1 randomized trial of MAGE-A3 ASCI vs. Placebo. Eligible patients must have cutaneous melanoma expressing MAGE-A3 with histologically proven macroscopic nodal disease (AJCC Stage IIIB-C). Central randomization uses an internet-based algorithm accounting for the following factors: Stage of the disease (IIIB, IIIC and IIITx), TNM nodal category (N1, N2 and N3), primary category (Tx-0 or T1-2 or T3 or T4), extracapsular extension (Yes, No), study center, prior treatm...