Phase I trial of an enhanced prostate-specific antigen-based vaccine and Anti-CTLA-4 antibody in patients with metastatic androgen-independent prostate cancer

Because of the clinical benefit associated with immune response seen with PSA-TRICOM-based vaccines and the knowledge that blocking CTLA-4 can further augment immune responses, the combination of this vaccine with anti-CTLA-4 is promising. Because of the nature of the autoimmune events associated with anti-CTLA-4 antibodies, a dose-escalation study will provide evidence of the maximum tolerated dose on which to base phase II combinations designed to answer questions about the efficacy of the combination.