Atezolizumab for the Treatment of Patients with Resectable, Human Papillomavirus Related Oropharyngeal Squamous Cell Carcinoma

Summary

Objectives

PRIMARY OBJECTIVES:
I. To determine the safety tolerability of 2 doses of single agent atezolizumab in HPV-driven oropharyngeal squamous cell carcinoma (OPSCC).
II. To determine the pathologic response to 2 doses of single agent atezolizumab in HPV-driven OPSCC.

SECONDARY OBJECTIVES:
I. To evaluate the event free survival at 2 years after treated with this approach followed by pathologic directed adjuvant therapy.

EXPLORATORY EFFICACY OBJECTIVES:
I. The exploratory efficacy objective for this study is to evaluate the efficacy of atezolizumab compared with control (previously studied and published in Nature) on the basis of the following endpoints:
Ia. Determine a biomarker profile of responders versus non-responders to atezolizumab by examining the following biomarkers in the tissue and blood.
Ib. Confirm that PD-1 blockade with atezolizumab will result in an effective proliferation and differentiation PD1+, TCF1+ stem like tumor infiltrating lymphocytes (TILs) in the tumor microenvironment (TME) of patients in HPV-driven OPSCC (correlate these findings with pathologic response).
Ic. Study the temporal differentiation and migration of effector-like cells and their correlation with evidence of pathologic response and tumor immune infiltration.
Id. Correlate these findings with evidence of response using circulating tumor deoxyribonucleic acid (ctDNA) in the peripheral blood.
Ie. Examine the B-cell antigen specific cell (ASC) infiltration and characteristics in the TME of patients and correlate these findings with clinical and pathologic responses.

OUTLINE:
Patients receive atezolizumab intravenously (IV) while on study. Patients undergo computed tomography (CT) scan and magnetic resonance imaging (MRI) throughout the study. Patients may undergo tumor biopsy while on study.