PILOT STUDY TO EVALUATE THE ANTI-TUMOR EFFECT OF DURVALUMAB IN PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN), HUMAN PAPILLOMA VIRUS (HPV) POSITIVE VERSUS NEGATIVE, WHEN TREATED BEFORE SURGERY

What we are studying

The purpose of this research study is to determine whether during this period of time, giving an antibody in the form of a medication called Durvalumab (study drug) can hold the tumor from growing and to examine the effect of this study drug against cancer. Antibodies are proteins produced by the defense system of the body (immune system) that have been made in the laboratory. This treatment helps increase the activity of the immune system that in many cases is decreased by the cancer. When the immune system is more active, it has a better chance to fight the cancer in the body, trying to limit the spread of the cancer. This medication is considered experimental for the treatment of SCCHN as it has not been yet approved by FDA.

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

  • Histologically or cytologically confirmed SCCHN of the oral cavity or oropharynx
  • Presence of radiologically documented disease
  • Willing to provide consent for an additional tissue biopsy for research purposes to allow a part of their surgical tumor tissue to be utilized for research and to donate samples of blood and saliva collected before and after treatment

What is involved

  • Receive Durvalumab twice before your scheduled surgery with 14 days between the two doses. If the time to your surgery is longer than 30 days
  • A third dose of treatment will be scheduled
  • Have the following tests and procedures during the Screening Visit (within 28 days prior to first drug administration): • Demographic information
  • History of tobacco and alcohol use
  • Medical history • Physical exam
  • Performance status assessment
  • Vital signs
  • Height
  • Weight
  • EKG
  • Current medications • Tumor biopsy • Imaging by CT scan or MRI
  • PET scan • Blood sample collection about two tablespoons of blood • Saliva sample collection: 5 ml of saliva will be collected by drooling into a large diameter tube. • HPV test done in the tumor tissue • Pregnancy test for women of childbearing potential

Compensation

Parking will be validated for study-related visits

Contact Information

Study Coordinator
Sharon Averill
Email
saverill@wakehealth.edu
Phone
336-713-6925
Principal Investigator
Mercedes Porosnicu

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.