NCT06254911

Pre-operative Atezolizumab in Patients With Resectable, Human Papillomavirus Related Oropharyngeal Carcinoma

Window of Opportunity Study of Pre-Operative Atezolizumab (ANTI PD-L1 ANTIBODY) for Patients With Resectable HPV Related Oropharyngeal Squamous Cell Carcinoma (OPSCC)

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well atezolizumab works in treating patients with human papillomavirus (HPV) related oropharyngeal squamous cell carcinoma that is able to be removed with surgery (resectable). Immunotherapy with atezolizumab, may include changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Detailed description

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.

Conditions

• Oropharynx Cancer, Stage I

Interventions

Type	Name	Description
BIOLOGICAL	Atezolizumab	Given IV
PROCEDURE	Transoral Surgery with cervical lymphadenctomy (neck dissection)	Undergo definitive surgical treatment to remove cancer from the tonsil or tongue base combined with removal of the at risk lymph nodes in the neck
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI

Timeline

• Start date: 2023-10-27
• Primary completion: 2026-12-16
• Completion: 2026-12-16
• First posted: 2024-02-12
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study