HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma

Summary

Participation Requirements

Description

This study aims to enroll 50 patients (male and female, age 18+) who have intermediate risk disease with histologically-confirmed head and neck squamous cell carcinoma with no evidence of distant metastasis. All patients will receive the same treatment and there is no active control group. In this t...

This study aims to enroll 50 patients (male and female, age 18+) who have intermediate risk disease with histologically-confirmed head and neck squamous cell carcinoma with no evidence of distant metastasis. All patients will receive the same treatment and there is no active control group. In this trial, patients will undergo biopsy followed by treatment with ISA101b vaccine which will be initiated 2 weeks prior to cisplatin-IMRT, and one week prior to the first dose of pembrolizumab. Vaccines will continue for 2 additional administrations at weeks 2 and 5, on the same day as successive pembrolizumab infusions. Pembrolizumab will be initiated 1 week prior to cisplatin-IMRT at the dose of 200 mg IV q3 weeks (+/- 3 days). Pembrolizumab will be continued concurrently through cisplatin-IMRT (weeks 3, 6 ), and continued for a 15 week maintenance period after completion of cisplatin-IMRT for a total pembrolizumab treatment period of 24 weeks (8 doses; 6 months).

Tracking Information