A Pilot Study of Presurgical Cemiplimab with Chemotherapy and Cetuximab in Patients with Head and Neck Cancer

Share
Print

Full Title

A Pilot Study of Neoadjuvant Cemiplimab with Platinum-Doublet Chemotherapy, and Cetuximab in Patients with Resectable, Locally Advanced Head & Neck Squamous Cell Carcinoma

Purpose

Researchers are doing this study to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab is a safe treatment. They also want to know if receiving this combination treatment before surgery may allow patients to forgo the standard radiation treatment given after surgery.

Chemotherapy with platinum-containing drugs and the use of the drug cetuximab are standard treatments for head and neck cancer. Cemiplimab is an immunotherapy that works by boosting the ability of the immune system to detect and destroy cancer cells. The medications used in this study are given intravenously.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have operable squamous cell carcinoma of the head and neck that has arisen from the oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx.
  • Patients may not have received prior treatment with chemotherapy, immunotherapy, or radiation therapy for head and neck cancer.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Lara Dunn at 646-608-3787.

Protocol

20-445

Phase

I

Investigator