RecruitingMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell Carcinoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

30 states

Healthy volunteers

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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.

Sponsor: National Cancer Institute (NCI)

You may qualify if…

✓ 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.