The double-blind, randomised controlled phase II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with head and neck mucosal melanoma followed by standard therapy

INTERVENTION: The injections of 100 million of alpha‐GalCer pulsed APCs on day 7 and 10 into nasal submucosa. The injections of 100 million of untreated APCs on day 7 and 14 into nasal submucosa. CONDITION: Head and neck squamous cell carcinoma PRIMARY OUTCOME: Recurrence‐free survival SECONDARY OUTCOME: Two‐year recurrence‐free survival; Two‐year overall survival; Evaluation of NKT cell specific immune response; Safety profile INCLUSION CRITERIA: Stage IV HNSCC; Complete responce (CR) after first standard therapy; Within 8 weeks after the assessment of CR; Within 4 months after previous treatment; pathological diagnosis of squamous cell carcinoma; Performance status is 0 ‐ 2; Normal bone marrow, liver and renal functions; Written informed concent.