OncoMatch/Clinical Trials/NCT06589804
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Is NCT06589804 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Cetuximab and Pembrolizumab for metastatic head and neck squamous cell carcinoma.
Treatment: Cetuximab · Pembrolizumab — This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) combined positive score PD-L1 positive (CPS ≥ 1) (CPS ≥ 1)
Patient must have a combined positive score PD-L1 positive (CPS ≥ 1) tumor.
Required: CDKN2A p16 negative
Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH).
Disease stage
Required: Stage IV (AJCC v8)
Metastatic disease required
Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8; Stage IV Hypopharyngeal Carcinoma AJCC v8; Stage IV Laryngeal Cancer AJCC v8; Stage IV Lip and Oral Cavity Cancer AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — definitive or adjuvant
Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.
Cannot have received: systemic therapy for recurrent/metastatic disease
Patients should not have received any prior treatment in the recurrent or metastatic setting.
Lab requirements
Blood counts
ANC ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3; Hemoglobin (Hgb) ≥ 9 g/dL (if < 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).
Kidney function
Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min using Cockcroft-Gault formula for participant with creatinine levels > 1.5 x institutional ULN.
Liver function
Total bilirubin ≤ 1.5 x ULN OR direct bilirubin < ULN for participant with total bilirubin > 1.5 x institutional ULN. AST/ALT ≤ 3.0 x ULN unless liver metastases are present in which case < 5.0 x ULN.
Cardiac function
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
ANC ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3; Hemoglobin (Hgb) ≥ 9 g/dL (if < 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL). Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min using Cockcroft-Gault formula for participant with creatinine levels > 1.5 x institutional ULN. Total bilirubin ≤ 1.5 x ULN OR direct bilirubin < ULN for participant with total bilirubin > 1.5 x institutional ULN. AST/ALT ≤ 3.0 x ULN unless liver metastases are present in which case < 5.0 x ULN. Cardiac risk assessment: NYHA class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
- Fremont - Rideout Cancer Center · Marysville, California
- VA Palo Alto Health Care System · Palo Alto, California
- UCHealth Memorial Hospital Central · Colorado Springs, Colorado
- Memorial Hospital North · Colorado Springs, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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