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

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 pembrolizu

Trial Details

NCT ID
NCT06589804
Phase
PHASE3
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Biospecimen Collection
  • Cetuximab
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Pembrolizumab
  • Positron Emission Tomography
Locations (sample)
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Marysville, California, United States|39.14573,-121.59135
  • Palo Alto, California, United States|37.44188,-122.14302
  • Colorado Springs, Colorado, United States|38.83388,-104.82136
  • Colorado Springs, Colorado, United States|38.83388,-104.82136

Key Eligibility Criteria

  • 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 e…

For full eligibility, visit ClinicalTrials.gov.

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