MEDI4736 Alone or in Combination with Tremelimumab versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients

What we are studying

You have been asked to take part in this study because you have a type of head and neck cancer which is called Squamous Cell Carcinoma of the Head and Neck (SCCHN). Your cancer has either returned or has spread to other parts of your body (either recurrent or metastatic). This study is being carried out to see if investigational anti-cancer drugs MEDI4736 and tremelimumab will work better than standard drugs (EXTREME regimen: made up of 3 different cancer drugs) for treating this type of cancer. It will also test if the study drugs are as safe as the EXTREME regimen. This is an investigational study and both MEDI4736 and tremelimumab are investigational drugs that have not been approved by the United States Food and Drug Administration (FDA). MEDI4736 and tremelimumab are antibodies (proteins produced by the defense system of the body [immune system]) that have been made in the laboratory. Both MEDI4736 alone or given with tremelimumab may boost the ability of your immune system to detect and fight cancer.

Who we are studying

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

Eligibility Criteria

  • Informed consent
  • Histologically confirmed recurrent or metastatic SCCHN (oral cavity
  • Oropharynx
  • Hypopharynx
  • Or larynx) not amenable to local curative therapy with surgery or radiation therapy
  • Measurable tumor that was not previously exposed to radiation treatment
  • No prior exposure to immune-mediated therapy
  • Adequate organ and marrow function
  • Non-Pregnant or nursing.

What is involved

  • Comprehensive physical exams and vitals at each visit
  • Concomitant medication history
  • HPV status determination
  • Medical surgical history
  • Tobacco use history
  • Blood draws for routine health checks
  • HIV/Hep B/Hep C testing
  • Tumor biopsy or archival sample for PD-L1 test
  • CT or MRI every 6 weeks for 6 months
  • Then every 8 weeks thereafter
  • Ecgs
  • Questionnaires
  • IV administration of study drug as frequently as every 4 weeks
  • Or IV administration of Standard of Care drug weekly.

Compensation

A stipend will be provided to assist with parking and travel related to study visits.

Contact Information

Study Coordinator
Sharon Averill
Email
saverill@wakehealth.edu
Phone
336-713-6925
Principal Investigator
Marcelo Bonomi, MD

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.