Neoadjuvant vidutolimod and nivolumab in high-risk resectable melanoma: A prospective phase II trial.

ABSTRACT: Intratumoral TLR9 agonists and anti-PD-1 produce clinical responses and broad immune activation. We conducted a single-arm study of neoadjuvant TLR9 agonist vidutolimod combined with anti-PD-1 nivolumab in high-risk resectable melanoma. In 31 evaluable patients, 55% major pathologic response (MPR) was observed, meeting primary endpoint. MPR was associated with necrosis, and melanophagocytosis with increased CD8⁺ tumor-infiltrating lymphocytes and plasmacytoid dendritic cells (pDCs) in the tumor microenvironment, and increased frequencies of Ki67⁺CD8⁺ T cells peripherally. MPRs had an enriched pre-treatment gene signature of myeloid cells, and response to therapy was associated with gene signatures of immune cells, pDCs, phagocytosis, and macrophage activati

SUBMITTER: Davar D 

PROVIDER: S-EPMC11560503 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature