Leukoplakia Clinical Trial
Official title:
A Phase II Open Label, Single Arm Study to Evaluate the Efficacy of Pembrolizumab for Leukoplakia
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.
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. ;
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