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Clinical Trial for Head and Neck Cancer: Cetuximab with Pembrolizumab

This study is testing if adding the anti-cancer drug cetuximab to the standard treatment, pembrolizumab, can improve outcomes for people with head and neck squamous cell carcinoma (HNSCC) that has returned or spread. Cetuximab is a monoclonal antibody that targets a protein called EGFR on cancer cells, which may help stop their growth. Pembrolizumab is an immunotherapy that helps your body's immune system fight cancer. You may be able to join if you have HNSCC that has come back or spread, and you haven't been treated for this recurrent or metastatic disease before. The main goal is to see if the combination treatment helps people live longer. This study is currently recruiting 158 participants, but its status is unclear.

Study design
This is an interventional study comparing two treatment approaches for head and neck cancer. It plans to enroll 158 participants.
What's involved
You would undergo blood sample collection, CT or PET/CT scans, and MRI scans. You would receive either pembrolizumab alone or pembrolizumab with cetuximab intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be assessed for up to 5 years after randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~158 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCetuximabComputed TomographyMagnetic Resonance ImagingPembrolizumabPositron Emission Tomography

At a glance

Recruiting sites
191 of 199 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over Time from randomization to death from any cause, assessed up to 5 years

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Hypopharyngeal Squamous Cell Carcinoma
Metastatic Laryngeal Squamous Cell Carcinoma
Metastatic Oral Cavity Squamous Cell Carcinoma
Metastatic Oropharyngeal Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Neck Squamous Cell Carcinoma of Unknown Primary
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Refractory Head and Neck Squamous Cell Carcinoma
Refractory Hypopharyngeal Squamous Cell Carcinoma
Refractory Laryngeal Squamous Cell Carcinoma
Refractory Oral Cavity Squamous Cell Carcinoma
Refractory Oropharyngeal Squamous Cell Carcinoma
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

Explore related trials

Head and Neck Squamous Cell CarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

199 sites across 30 states
Illinois32
Wisconsin26
Pennsylvania19
Missouri13
Michigan12
Minnesota10
Kansas9
Iowa8

Study leadership

  • Siddharth Sheth · PRINCIPAL_INVESTIGATOR · Alliance for Clinical Trials in Oncology

Who to contact

Site Public Contact
501-686-8274
Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).
Previously untreated for recurrent and/or metastatic disease incurable by local therapies.
Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.
Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.
Measurable disease.
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.
Patient must have a combined positive score PD-L1 positive (CPS \>/= 1) tumor.
Any radiation therapy must be completed \>= 10 days prior to registration.
Patients should not have received any prior treatment in the recurrent or metastatic setting.
Prior therapy with neoadjuvant or induction anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was \>= 26 weeks prior to registration without evidence of disease progression during that treatment period.
Patient has not received a live vaccine within 30 days prior to registration.
Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).
Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.
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).
Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Absolute neutrophil count (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 upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the 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.
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x ULN unless liver metastases are present in which case \< 5.0 x ULN.
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
For treated/stable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
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.
Patients does not have a history of active myocarditis.
Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.
Patient does not have a history of solid organ transplantation.

What this trial measures

  • Overall survival (OS)Time from randomization to death from any cause, assessed up to 5 years

    Will be estimated using the Kaplan-Meier method. Will be based on the stratified log-rank test that will compare the distributions across the treatment arms. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well, where the multivariable Cox model will also adjust for other key baseline factors of interest. Hazard ratios and 95% confidence intervals, along with likelihood ratio p-values will be reported from these Cox models. Forest plots will be used to illustrate the comparisons between the arms within subgroups defined by stratification factors and key baseline characteristics.