Phase Ib trial of the CpG-A Oligonucleotide CMP-001 combined with pembrolizumab (Pembro) in patients with advanced melanoma.

TPS9593Background: We are developing CMP-001 to facilitate activation of the innate immune response within a tumor that will enhance response to anti-PD-1/L1 therapy. CMP-001 is comprised of a CpG-A oligodeoxynucleotide (ODN) formulated within a virus-like particle. The CpG ODN is a TLR9 agonist that activates plasmacytoid dendritic cells leading to the production of high local concentrations of Type I interferons and subsequent activation of anti-tumor CD8+ T cells that express PD-1. In syngeneic mouse models intratumoral delivery of CMP-001 in combination with systemic anti-PD-1 antibody improved tumor growth control and promoted regression in injected and un-injected tumors when compared to either agent alone. These data provide the rationale to study this combination in cancer patients. CMP-001 has been previously studied in over 700 human subjects for non-oncology indications. Adverse events noted in prior studies were primarily grade 1/2 fever, chills, flu-like symptoms and local injection-site reac...