Now Enrolling: The EA3211 study is evaluating a new treatment strategy for certain patients with head and neck cancer

Most cancers of the head and neck begin in the squamous cells that line the mucous membranes. This type of cancer is known as head and neck squamous cell carcinoma (HNSCC). When cancer spreads to other areas in the body, it is called metastatic cancer. Clinical trial EA3211 is for patients with metastatic HNSCC that has spread to only a few other locations in the body and remains small.

The usual treatment approach for these patients is therapy with Food and Drug Administration (FDA)-approved drugs, often immunotherapy. Immunotherapy drugs work by stimulating the immune system to destroy cancer cells. Sometimes, doctors use combinations of drugs (chemotherapy, immunotherapy, or targeted therapy, for example) as well as radiation or surgery.

Over the past 5 years, immunotherapy advances have greatly improved results for patients with HNSCC. Medicines such as pembrolizumab and nivolumab have significantly increased overall survival rates (how long people live after treatment). Unfortunately, long-term survival rates are still low, and even better treatments are needed.

One promising strategy for patients with metastatic HNSCC is the addition of radiation therapy after the completion of treatment with immunotherapy and chemotherapy. Recent research suggests that radiation to the location where the cancer started and to the few areas where it has spread may lead to better results for patients. The EA3211 study aims to confirm this by comparing this new approach to treatment with only immunotherapy and chemotherapy.

This randomized phase 3 trial will enroll 290 patients. To be eligible, patients must have HNSCC that began in the mouth, throat, or voice box (larynx). Cancer must be present in the head and neck area, as well as in one to four other locations in the body. Patients may have had surgery previously for their head and neck cancer but must not have had any prior radiation therapy in their head or neck.

All patients in the study will complete four cycles of chemotherapy and immunotherapy with pembrolizumab. Then, patients will be randomly assigned by a computer to receive either more pembrolizumab or more pembrolizumab and radiation therapy. All patients will be followed for a total of 3 years after enrolling in the study.

EA3211 is led by David Sher, MD, MPH, of UT Southwestern Medical Center.

Learn more about EA3211 at ecog-acrin.org.