Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma in Situ

Carcinoma, Squamous Cell

Squamous Intraepithelial Lesions of the Cervix

Uterine Cervical Dysplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 4 cycles (24 weeks).

Maria Garcia-Jimenez, MD

Rosleen Mala

John A. Glaspy, MD

John A Glaspy, MD

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).

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

Will correlate PD-L1 positivity with response to pembrolizumab.

Assess percentage of subjects who respond to treatment who are HPV positive (using p16 positivity from pathology) compared to percentage of subjects who respond to treatment who are HPV negative in order to evaluate if HPV positivity correlates with improved response to treatment.

Will evaluate HPV clearance as a surrogate endpoint.

Will assess the percent of patients with pathologic complete response at 6 months.

Merck Sharp & Dohme LLC

Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for cervical squamous intraepithelial neoplasia 2