Oral Cavity Carcinoma Clinical Trial
Official title:
Personalized, Randomized, Phase 2 Study of Pembrolizumab (MK-3475) for High Risk Oral Intra-Epithelial Neoplasias
This randomized phase II trial studies how well pembrolizumab works in treating patients with high risk oral intraepithelial neoplasia. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVE: I. To determine oral cancer-free survival of patients with high risk oral intra-epithelial neoplasias (IEN) treated with pembrolizumab versus observation. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of pembrolizumab for patients with oral IEN. II. To determine the histologic and clinical response rates (in the subgroup of patients with clinically evident measurable oral IEN lesions) to pembrolizumab. III. To characterize the immune infiltrate in oral IEN lesions before and after treatment with pembrolizumab. EXPLORATORY OBJECTIVES: I. To assess predictive, tissue-and blood-based, biomarkers of benefit from pembrolizumab in oral IEN. II. To determine the presence of neo-antigens in IEN lesions before and after treatment, and their correlation with oral cancer-free survival and immune infiltrate characteristics. III. To evaluate the oral micro-biome before and after treatment with pembrolizumab and its association with neo-antigens and benefit from treatment. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo observation. ARM B: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6, 9, 12, 18, 24, 30, and 36 months and then periodically thereafter. ;
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