TP042/#1526 A Single Arm Phase II Study on Pembrolizumab in Pre-Neoplastic High Grade HPV-related Vulvar and Cervical Lesions

Objectives This is a single arm phase II trial evaluating Pembrolizumab as neoadjuvant treatment before surgical conization and/or partial or radical vulvectomy in patients with pre-neoplastic cervical and vulvar HPV- related high grade lesions. Primary objective of the study is to determine the efficacy of Pembrolizumab in leading histopathologic complete regression of cervical HSIL. Secondary objectives are: to determine the efficacy of Pembrolizumab in leading histopathologic complete regression of VIN 2–3; to evaluate the safety and tolerability of Pembrolizumab in patients with HPV-related pre-neoplastic vulvar and cervical lesions; to determine Pembrolizumab efficacy in the virologic clearance of HPV. Exploratory objectives are: to evaluate tissue immune responses to pembrolizumab in cervical and vulvar samples and to evaluate the influence of vaginal microbiome on Pembrolizumab response. Methods Patients with histologically confirmed H-SIL and/or VIN 2–3 will be treated with Pembrolizumab 200 mg flat dose every 3 weeks for 5 cycles. Within 4 weeks from the last Pembrolizumab administration patients will be submitted to surgical conization (either cold knife conization or LEEP) and/or partial or radical vulvectomy. During the screening phase patients will receive blood and stool specimen’s collection. Genotyping for HPV will be performed at baseline, surgery and at safety follow up visit. Results Trial in progress: there are no available results at the time of submission. Conclusions Trial in progress: there are no available conclusions at the time of submission