NCT03603223

Pembrolizumab in Treating Participants With Leukoplakia

A Phase II Open Label, Single Arm Study to Evaluate the Efficacy of Pembrolizumab for Leukoplakia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II pilot trial studies how well pembrolizumab works in treating leukoplakia. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. Clinical response rate at 6 months? percent of patients with complete response and partial response at 6 months. SECONDARY OBJECTIVES: I. Histologic response rate at 6 months. II. Change in clinical impression based on photographs of the lesion. III. Clinical response rate at 9 months and 12 months. IV. Toxicity. EXPLORATORY OBJECTIVES: I. PD-L1 expression in leukoplakia lesions and biomarker analysis. OUTLINE: Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days and every 3 months for 2 years.

Conditions

• Erythroleukoplakia
• Leukoplakia
• Verrucous Oral Leukoplakia

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2019-05-03
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2018-07-27
• Last updated: 2025-07-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study