Asset Details
Do you wish to reserve the book?
TP042/#1526 A single arm phase II study on pembrolizumab in pre-neoplastic high grade HPV-related vulvar and cervical lesions
Hey, we have placed the reservation for you!
By the way, why not check out events that you can attend while you pick your title.
Oops! Something went wrong.
Looks like we were not able to place the reservation. Kindly try again later.
Are you sure you want to remove the book from the shelf?
TP042/#1526 A single arm phase II study on pembrolizumab in pre-neoplastic high grade HPV-related vulvar and cervical lesions
Do you wish to request the book?
TP042/#1526 A single arm phase II study on pembrolizumab in pre-neoplastic high grade HPV-related vulvar and cervical lesions
Please be aware that the book you have requested cannot be checked out. If you would like to checkout this book, you can reserve another copy
We have requested the book for you!
Your request is successful and it will be processed during the Library working hours. Please check the status of your request in My Requests.
Oops! Something went wrong.
Looks like we were not able to place your request. Kindly try again later.
Journal Article
TP042/#1526 A single arm phase II study on pembrolizumab in pre-neoplastic high grade HPV-related vulvar and cervical lesions
2022
Overview
ObjectivesThis 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.MethodsPatients 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.ResultsTrial in progress: there are no available results at the time of submission.ConclusionsTrial in progress: there are no available conclusions at the time of submission
Publisher
BMJ Publishing Group Ltd,Elsevier Inc,Elsevier Limited
