OncoMatch/Clinical Trials/NCT01810913
Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer
Is NCT01810913 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Cetuximab and Atezolizumab for oropharyngeal p16ink4a-negative squamous cell carcinoma.
Treatment: Atezolizumab · Cetuximab · Cisplatin · Docetaxel — This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. 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. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 negative (negative)
oropharynx (p16 negative); Patients with oropharyngeal cancer must have p16-negative based on central review prior to Step 2 registration
Required: EGFR analysis required
mandatory tissue submission for epidermal growth factor receptor (EGFR) analysis
Required: HPV analysis required
for oropharyngeal cancer patients, human papilloma virus (HPV) analysis
Disease stage
Required: Stage III, IV
Performance status
ZUBROD 0–1
Prior therapy
Must have received: surgery — gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration
Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration
Cannot have received: systemic chemotherapy
Exception: prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Cannot have received: anti-EGFR therapy
Exception: prior anti-EGFR therapy for a different cancer is allowable
Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer
Cannot have received: radiotherapy
Exception: if would result in overlap of radiation therapy fields
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cannot have received: immune checkpoint inhibitor (anti-PD-1 therapy, anti-PD-L1 therapy, anti-PD-L2 therapy)
a prior anti-PD-1, anti-PD-L1, or anti-PD-L2 agent is not permitted
Lab requirements
Blood counts
AGC >= 1,500 cells/mm^3 (phase II); PHASE III: Leukocytes >= 2,500 cells/mm^3, ANC >= 1,500 cells/mm^3, Platelets >= 100,000 cells/mm^3, Hemoglobin >= 8.0 g/dL
Kidney function
Serum creatinine institutional ULN or creatinine clearance >= 50 ml/min within 14 days prior to registration
Liver function
Total bilirubin < 2 x institutional ULN (phase II); PHASE III: Total bilirubin <= 1.5 x institutional ULN (Gilbert disease <= 3 x ULN); AST or ALT < 3 x institutional ULN; Alkaline phosphatase <= 2.5 x institutional ULN
AGC >= 1,500 cells/mm^3; Platelets >= 100,000 cells/mm^3; Hemoglobin >= 8.0 g/dl; Total bilirubin < 2 x institutional ULN; AST or ALT < 3 x institutional ULN; Serum creatinine institutional ULN or creatinine clearance >= 50 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- The Kirklin Clinic at Acton Road · Birmingham, Alabama
- Banner University Medical Center - Tucson · Tucson, Arizona
- University of Arizona Cancer Center-North Campus · Tucson, Arizona
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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