Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
A Phase II Open-Label, Single Arm Pilot Study to Evaluate the Safety and Efficacy of Pembrolizumab for High-Grade Cervical Intraepithelial Neoplasia
This phase II trial studies the effect of pembrolizumab on cervical 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. Proportion of subjects with pathologic complete response (no evidence of dysplasia). SECONDARY OBJECTIVES: I. Safety and tolerability of pembrolizumab in subjects with cervical intraepithelial neoplasia (CIN). II. Proportion of subjects with pathologic partial response (regression to a lower grade of dysplasia). EXPLORATORY OBJECTIVES: I. Evaluation of Programmed Death-Ligand 1 (PD-L1) expression in CIN lesions as a biomarker of response to therapy. II. Evaluation of Human Papillomavirus (HPV) status as a biomarker of response to therapy. III. Evaluation of HPV clearance as a surrogate endpoint. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 6 weeks for 4 cycles (24 weeks). ;
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