Spots Global Cancer Trial Database for Non-randomized, Open-label Study of Intralesional Nivolumab for High Risk Oral Premalignant Lesions

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Trial Identification

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

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

Study ID: NCT05327270

Conditions

Head and Neck Cancer

Interventions

Nivolumab

Study Description

Brief Summary: To characterize the safety and tolerability of nivolumab injected intralesionally in patients with high-risk oral premalignant lesions.

Detailed Description: 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.