Ongoing Trials: A closer look at ECOG-ACRIN’s studies for patients with head and neck cancer

Head and neck cancers represent only about 4 percent of all cancers diagnosed in the United States—yet they are some of the most difficult cancers for patients to navigate, due to functional problems and differences in appearance associated with this disease and its treatment. Below, we highlight the following clinical trials as opportunities for patients affected by head and neck cancer. Participation contributes to necessary research aimed at improving treatment outcomes. Click on the ‘learn more’ links for patient materials and eligibility requirements.

Advanced-stage head and neck cancer

• The EA3211 trial is for patients with head and neck squamous cell carcinoma (HNSCC) that has spread to a limited number of (four or fewer) other places in the body. The usual approach (i.e., the standard treatment most patients receive) is treatment with Food and Drug Administration (FDA)–approved drugs, typically including chemotherapy and immunotherapy such as pembrolizumab (pem-broh-LIH-zoo-mab). These drugs may help the body fight cancer. Many patients who complete this standard treatment will continue receiving pembrolizumab alone as maintenance therapy for as long as it helps control the cancer. However, the 2-year survival rate is only about 30 percent with this approach. The purpose of this study is to test whether combining radiation therapy with pembrolizumab as maintenance therapy will lead to better outcomes than pembrolizumab alone. Learn more.

• The EA3191 trial is for patients with HNSCC that has come back, or with a new cancer in a different area of the head and neck, after surgery and radiation. One usual treatment approach is to give patients radiation with chemotherapy. This can reduce the likelihood of the cancer recurring in the head and neck area, but it has not been proven to make patients live longer. This study is exploring a different approach. It is testing what happens when an immunotherapy drug (pembrolizumab, see above) is given by itself after surgery. Researchers aim to discover if using pembrolizumab after surgery is better or worse than the usual treatment of chemotherapy with radiation. Learn more.

Thyroid cancer with a gene mutation

• The EA3231 trial is for patients with thyroid cancer that does not respond to or has stopped responding to initial treatment with medicines known as VEGFR-targeting tyrosine kinase inhibitors (TKIs). The trial is specifically for patients whose thyroid cancer has a gene mutation called BRAF V600E. The FDA has approved several TKIs for these patients. These are oral medications, and patients may take them sequentially over several years to control this type of cancer, which is often slow-growing. In June 2022, the FDA approved the two-drug TKI combination of dabrafenib (da-BRAF-eh-nib) and trametinib (tra-MET-eh-nib) for treating people with most types of advanced solid tumors that have the BRAF V600E mutation. This study is comparing treatment with dabrafenib-trametinib to treatment with cabozantinib (ka-boe-ZAN-ti-nib), another FDA-approved oral TKI medicine for thyroid cancer. EA3231 is the first trial to compare these two standard treatments—and the goal is to discover which approach may be safer and more effective. Learn more.

Head and neck cancer with a gene mutation

• Approximately one-quarter to one-third of patients with head and neck cancer have tumors with a specific gene mutation known as p53. A previous study showed that these patients have a higher risk of the cancer coming back. The EA3132 trial is for patients with p53 mutated–head and neck cancer who have had surgery. It is evaluating whether adding chemotherapy to radiation after surgery will lower the risk of the cancer returning. Doctors are finding that for many patients with head and neck cancer that has spread to nearby tissue, adding chemotherapy improves on the results they would have experienced with radiation alone. This trial will help doctors find out whether the presence of p53 mutation, as well as other possible traits in these tumors, may be “biomarkers.” Biomarkers are signals that can help predict which patients will have better results with chemotherapy and radiation. Learn more.