NCT05110781

Atezolizumab Before Surgery for the Treatment of Regionally Metastatic Head and Neck Squamous Cell Cancer With an Unknown or Historic Primary Site

Neo-Adjuvant Atezolizumab Prior to Definitive Surgical Resection of Regionally Metastatic Head &Amp; Neck Cutaneous Squamous Cell Carcinoma With an Unknown or Historic Primary Site: A Window Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Arnaud Bewley, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 adjuvant therapy. 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.

Conditions

• 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

Interventions

Type	Name	Description
BIOLOGICAL	Atezolizumab	Given IV
RADIATION	Radiation Therapy	Undergo radiation therapy
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2021-12-07
• Primary completion: 2022-05-02
• Completion: 2023-04-18
• First posted: 2021-11-08
• Last updated: 2023-09-05
• Results posted: 2023-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study