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BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients

Oropharyngeal Cancer Clinical Trial

Official title:
A Phase 2 Study to Assess the Effect of BALSTILIMAB (AGEN2034) on Viral Clearance in HPV-positive Oropharyngeal Cancer Patients With Persistent HPV Detection in Plasma cfDNA After Definitive Therapy

Clinical Trial Summary

This study aims to leverage this unique property of HPV+ OPC to detect possible minimal residual disease represented by persistent viral detection after the completion of definitive treatment. The study will offer adjuvant immune therapy to patients with persistent viral detection and evaluate the clearance of viral load. It will evaluate the rate of viral clearance with immune therapy and establish the link between viral clearance and long-term disease control.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05363709
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Luana Guimaraes de Sousa, MD
Phone (832) 728-7849
Email lgsousa@mdanderson.org
Status Recruiting
Phase Phase 2
Start date October 18, 2023
Completion date February 15, 2028
View Details
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