BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients

Description

Objectives:

Primary Objective:

To assess whether anti-PD1 will lead to the clearance of the virus in the plasma cfDNA in HPV+ OPC patients with persistent cfDNA HPV following definitive therapy

Secondary Objectives:

* One-year recurrence-free survival (1-yr RFS),
* 2-year RFS (2-yr RFS),
* Overall survival (2-yr OS),
* Safety and tolerability
* Compliance
* Quality of life (EORTC C30 will be utilized)

Correlative/Exploratory Objectives:

* Time to viral clearance in the oral rinse and plasma cfDNA with anti-PD1 treatment
* The concordance between plasma HPV and oral rinse HPV at diagnosis, post-definitive treatment and during adjuvant treatment
* The correlation between tumor mutations and persistence of HPV in oral rinse/cfDNA.
* The correlation between recurrence site (loco-regional vs. distant metastasis) and oral rinse vs. plasma HPV detection