NCT04712851

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

A Phase II Open-Label, Single Arm Pilot Study to Evaluate the Safety and Efficacy of Pembrolizumab for High-Grade Cervical Intraepithelial Neoplasia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cervical Intraepithelial Neoplasia
• Cervical Squamous Cell Carcinoma In Situ
• Cervical Squamous Intraepithelial Neoplasia 2

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2021-06-30
• Primary completion: 2027-01-31
• Completion: 2028-01-31
• First posted: 2021-01-15
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study