Jonsson Comprehensive Cancer Center
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 progres…
Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial. * Subjects must have leukoplakia, erythroleukoplakia or proliferative verrucous leukoplakia (PVL) with lesions measurable in 2 dimensions, not amenable to surgical resection or radiation or who have refused surgery or radiation. Patients must have at least 1 lesion that can be followed on treatment. (Patients who have undergone complete excision of lesions and are clinically without evidence of disease will not be eligible for study.) * Evidence of moderate or severe dysplasia or carcinoma in s…
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