Abstract
Dendritic cells (DCs) are highly specialized antigen-presenting cells which are essential for the activation of immune responses. Autologous DCs, directly isolated from peripheral blood, loaded with tumor antigens and matured in vitro, can induce tumor-specific immune responses and clinical responses in cancer patients. In this phase III clinical trial, patients with resected stage IIIB or IIIC cutaneous melanoma (AJCC 7th edition) were randomized in a 2:1 ratio to adjuvant treatment with DC vaccination or placebo. The active treatment arm consisted of intranodal injections with autologous CD1c+ myeloid DCs and plasmacytoid DCs loaded with tumor antigens (gp100, tyrosinase, MAGE-C2, MAGE-A3 and NY-ESO-1). When adjuvant treatment with anti-PD1 antibodies became available in the Netherlands in November 2018, accrual was stopped prematurely after inclusion of 151 patients. The primary endpoint is the 2-year recurrence-free survival (RFS) rate. Secondary endpoints include overall survival, immunological response and safety. In January 2020, we performed a preplanned interim analysis. At that time, 102 patients reached mature data for primary endpoint analysis (recurrence of disease within 2 years of randomisation or at least 2-year follow-up). Thirty-eight percent of patients were female and the median age at start was 55.7 years (range 27-78). At inclusion, 51% of patients had stage IIIB disease and 49% stage IIIC disease. Two-year RFS rate was 21.4% in the treatment arm and 25% in the control arm (HR 1.05; 95% CI: 0.47-3.23), providing no statistically significant evidence of a treatment effect (p=0.67). Our phase III clinical trial with adjuvant DC vaccination in stage IIIB and IIIC melanoma patients showed no benefit over placebo in terms of 2-year RFS. Correlative analysis of skin-test infiltrating lymphocytes for markers of immunological and clinical response are ongoing.
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