A Study to Evaluate the difference between the Standard of Care Chemo-radiotherapy and the Standard of Care Chemo-radiotherapy plus the drug Avelumab.

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.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • No prior therapy
  • Available tumor samples for submission or willing to undergo further tumor biopsies
  • Adequate bone marrow function
  • Adequate renal and liver function
  • Negative pregnancy test
  • Able to comply with scheduled visits
  • Treatment plans
  • Laboratory tests
  • And other study procedures

What is involved

  • Physical examination
  • Electrocardiogram (ECG)
  • Performance status: a measurement of your activity level and your general well being
  • Blood draw for laboratory tests
  • Urine sample
  • Computed tomography (CT) scan or magnetic resonance imaging (MRI) and a positron emission tomography (PET) scan
  • Questionnaires

Compensation

None

Contact Information

Study Coordinator
Sharon Averill, RN
Email
[email protected]
Phone
-7748
Principal Investigator
Mercedes Porosnicu, MD

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Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.