Non-randomized, Open-label Study of Intralesional Nivolumab for High Risk Oral Premalignant Lesions

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.