NCT05327270

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Given by IT

Timeline

• Start date: 2022-09-13
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2022-04-14
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study