A Phase III Study of Chemoradiation with or without Avelumab Immunotherapy for Locally Advanced Head and Neck Cancer

Full Title

B9991016: A Randomized Double-Blind Phase 3 Study of Avelumab in Combination with Standard of Care Chemoradiotherapy (Cisplatin Plus Definitive Radiation Therapy) Versus Standard of Care Chemoradiotherapy in the Front-Line Treatment of Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Purpose

Chemotherapy and radiation in combination is a standard treatment for head and neck cancers. In this study, researchers want to see if adding the immunotherapy drug avelumab to chemoradiation is more effective than chemoradiation alone in patients with locally advanced head and neck cancer that is at high risk of returning after treatment.

Avelumab is an antibody that works by blocking a protein on tumor cells called PD-L1. Tumor cells make PD-L1 to help them evade being detected by the immune system. By blocking this protein, avelumab may improve the ability of the immune system to destroy a cancer. Avelumab and the chemotherapy used in this study are given intravenously (by vein).

Patients will be randomly assigned to receive chemoradiation plus avelumab or chemoradiation plus a placebo (inactive drug).

Eligibility

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

  • Patients must have high-risk locally advanced head and neck cancer.
  • Patients may not have previously received treatment for advanced head and neck cancer, nor inhibitors of PD-1 or PD-L1.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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 646-888-4233.

Protocol

17-126

Phase

III

Investigator