As yet there are no FDA-approved cancer vaccines for malignant melanoma, but encouraging response rates and low toxicities reported in phase I/II trials suggest that antigen-based active immunotherapy may complement current treatment modalities. The cumulative data for Canvaxin therapeutic polyvalent cancer vaccine represent the largest phase II clinical trial of any cancer vaccine. Univariate and multivariate analyses of these data have demonstrated the prognostic significance of this allogeneic whole-cell preparation as a postoperative adjuvant treatment for patients with stage III and IV melanoma. The vaccine has also been shown promising results after resection of stage II melanoma and in patients with regional in-transit disease. The consistent correlation between immune and clinical responses to the vaccine suggests that immune parameters may be used to monitor a patient's response to vaccine therapy.