Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT04712851
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).
Study:
NCT04712851
Study Brief:
Protocol Section:
NCT04712851