What we are studying
You are being asked to take part in this research study because you have locally advanced cancer of the head and neck. The main purpose of this study is to compare the effects (good and bad) of the study drug, avelumab in combination with standard of care (SOC) chemoradiotherapy to a placebo in combination with SOC chemoradiotherapy to see which is better.
If you participate in the study, you will first be assigned by chance (like the flip of a coin) to receive either avelumab (Group A) or matching placebo (Group B), along with the SOC chemoradiotherapy. You will have a 50% (1 in 2) chance of receiving either avelumab or matching placebo. Regardless of the group you will be assigned to, you will receive the SOC chemoradiotherapy of cisplatin and radiotherapy.
The screening, Lead-in phase, Chemoradiotherapy phase, and Maintenance phase, together will last for approximately 15 months. The Maintenance phase of the study will last 12 months. How long you are in this study will depend on your ability to safely tolerate the treatment, on how your cancer responds to the treatment, and on you and/or your study doctor’s decision to continue receiving treatment. After completing the treatment, you will be seen regularly approximately every 4 months by your study doctor, which is a part of regular follow-up care for your cancer.