A Phase 3 Study Assessing the Addition of Cetuximab to Standard Pembrolizumab Immunotherapy for Head and Neck Cancer

Full Title

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Platinum Refractory Disease (A092205) (CIRB)

Purpose

Researchers want to see if giving cetuximab with pembrolizumab immunotherapy is better than pembrolizumab alone for head and neck cancers. The people in this study have head and neck squamous cell carcinoma (HNSCC) that came back or spread after treatment. Their cancers are also resistant to platinum chemotherapy.

Cetuximab binds to a protein called EGFR, which is found on some types of tumor cells. This drug may help keep tumor cells from growing. Pembrolizumab helps the body’s immune system attack the tumor and may interfere with tumor growth and spread.

If you take part in this study, you will be randomly assigned to get pembrolizumab alone or with cetuximab. Both drugs are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have HNSCC that came back or spread after prior treatment.
  • Have not received treatment for advanced cancer.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Alan Ho’s office at 212-639-7952.

Protocol

25-349

Phase

Phase III (phase 3)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06589804