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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05327270
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Moran Amit, MD
Phone (713) 794-5304
Email mamit@mdanderson.org
Status Recruiting
Phase Phase 1
Start date September 13, 2022
Completion date June 30, 2024
View Details
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