A Phase II Open-Label, Single Arm Pilot Study to Evaluate the Safety and Efficacy of Pembrolizumab for High-Grade Cervical Intraepithelial Neoplasia
Jonsson Comprehensive Cancer Center
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.
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 cl…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female participants who are at least 21 years of age on the day of signing informed consent with active (not yet resected), histologically confirmed diagnosis of CIN grade 2 or 3 or carcinoma in situ (without invasive component) will be enrolled in this study. Subjects with multifocal disease are acceptable * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * A WOCBP who agrees to follow the contraceptive guidance during…
Interventions
- BiologicalPembrolizumab
Given IV
Location
- University of California at Los Angeles / Jonsson Comprehensive Cancer CenterLos Angeles, California