OBJECTIVES~Primary objective:~To characterize the safety and tolerability of nivolumab injected intralesionally in patients with high-risk oral premalignant lesions.~Secondary objectives:~To describe the objective response rate (ORR) in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions, according to modified World Health Organization (WHO) criteria.~To describe the pathologic complete response (CR) rate in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions.~To describe the major pathologic response rate in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions.~To evaluate systemic exposure of nivolumab following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions.~To assess the immunogenicity of nivolumab in patients with high-risk oral premalignant lesions.~To establish a recommended dose of intralesional nivolumab for further study in patients with high-risk oral premalignant lesions.
To characterize the safety and tolerability of nivolumab injected intralesionally in patients with high-risk oral premalignant lesions.