This phase II trial tests whether atezolizumab works to shrink tumors before surgery in
patients with head and neck squamous cell cancer with an unknown or historic primary site
that has spread to other places in the lymph nodes (regionally metastatic). Immunotherapy
with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack
the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving
atezolizumab before surgery may reduce the size of the tumor.
PRIMARY OBJECTIVE:I. Evaluate the rate of pathologic complete response (pCR) at the time of
surgery following neo-adjuvant atezolizumab in patients with regionally metastatic head and
neck cutaneous squamous cell carcinoma (HNSCCC).
SECONDARY OBJECTIVES:I. Further characterize the oncologic response to neo-adjuvant
atezolizumab and adjuvant atezolizumab in combination with radiation therapy in patients with
regionally metastatic HNSCCC:Ia. Determine the rate of major pathologic response (mPR) at the
time of surgery.Ib. Evaluate the 2-year event free survival (EFS) after completion of
II. Investigate the utility of conventional imaging and novel biomarkers in predicting and
assessing response to neoadjuvant atezolizumab therapy.IIa. Investigate associations between
pre-treatment tumor fludeoxyglucose F-18 (FDG) avidity and response to neoadjuvant
immunotherapy.IIb. Evaluate the ability of fine-cut contrast enhanced computed tomography
(CT) or magnetic resonance imaging (MRI) of the head and neck to assess response to
neoadjuvant immunotherapy prior to surgery.IIc. Evaluate the capabilities of serial liquid
biopsy analysis of tumor-associated exosomes to predict neoadjuvant immunotherapy response.
III. Evaluate the safety and tolerability of anti-PD-L1 with atezolizumab neo-adjuvant
therapy in resectable regional metastatic HNCSCC.IIIa. Quantify toxicity (adverse events)
determined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.
OUTLINE:Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1.
Treatment repeats every 21 days for 2 cycles in the absence of disease progression or
unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks
after surgery, patients with residual disease undergo standard of care radiation therapy and
receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats
every 21 days for up to 15 cycles in the absence of disease progression and unacceptable
toxicity.After completion of study treatment, patients are followed up every 3 months for up
to 3 years.
Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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