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Clinical Trial Summary

single arm phase II trial evaluating Pembrolizumab single agent as neoadjuvant treatment before surgical conization and/or partial or radical vulvectomy in patients with pre-neoplastic cervical and vulvar high grade lesions.


Clinical Trial Description

This is a single arm phase II trial evaluating Pembrolizumab single agent as neoadjuvant treatment before surgical conization and/or partial or radical vulvectomy in patients with pre-neoplastic cervical and vulvar high grade lesions. Patients with histologically confirmed H-SIL and/or VIN 2-3 lesions will be treated with Pembrolizumab 200 mg flat dose every 3 weeks for 5 cycles. Within 3 weeks from the last Pembrolizumab administration patients will be submitted to surgical conization or partial or radical vulvectomy. ;


Study Design


Related Conditions & MeSH terms

  • Cervical, Vaginal and Vulval Inflammatory Diseases

NCT number NCT04211103
Study type Interventional
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Domenica Lorusso, MD
Phone 0630157337
Email domenica.lorusso@policlinicogemelli.it
Status Recruiting
Phase Phase 2
Start date October 14, 2020
Completion date September 1, 2024