Spots Global Cancer Trial Database for Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

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Trial Identification

Brief Title: Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

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

Study ID: NCT04712851

Conditions

Cervical Intraepithelial Neoplasia

Cervical Squamous Cell Carcinoma In Situ

Cervical Squamous Intraepithelial Neoplasia 2

Interventions

Pembrolizumab

Study Description

Brief Summary: 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.

Detailed Description: 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).