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Study identifier: NCT06589804 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Metastatic Head and Neck Squamous Cell Carcinoma · Metastatic Hypopharyngeal Squamous Cell Carcinoma · Metastatic Laryngeal Squamous Cell Carcinoma  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 3
Planned participants158
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (192)

University of Arkansas for Medical SciencesLittle Rock, Arkansas, United StatesRecruiting
Fremont - Rideout Cancer CenterMarysville, California, United StatesTerminated
VA Palo Alto Health Care SystemPalo Alto, California, United StatesRecruiting
UCHealth Memorial Hospital CentralColorado Springs, Colorado, United StatesRecruiting
Memorial Hospital NorthColorado Springs, Colorado, United StatesRecruiting
Poudre Valley HospitalFort Collins, Colorado, United StatesRecruiting
Cancer Care and Hematology-Fort CollinsFort Collins, Colorado, United StatesRecruiting
Lutheran Hospital - Cancer Centers of ColoradoGolden, Colorado, United StatesRecruiting
UCHealth Greeley HospitalGreeley, Colorado, United StatesRecruiting
Medical Center of the RockiesLoveland, Colorado, United StatesRecruiting
Mount Sinai Medical CenterMiami Beach, Florida, United StatesRecruiting
Saint Alphonsus Cancer Care Center-BoiseBoise, Idaho, United StatesRecruiting

+ 180 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06589804