A Phase III Study of MEDI4736 with and without Tremelimumab versus Standard of Care in Recurrent/Metastatic Head and Neck Cancer

Full Title

A Phase III Randomized, Open-label, Multi-center, Global Study of 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

Purpose

This is a randomized study to determine the effectiveness and safety of MEDI4736 with and without tremelimumab for the treatment of patients with squamous cell carcinoma of the head and neck who have not received prior systemic chemotherapy for recurrent or metastatic disease.

Patients will be randomly assigned to receive MEDI4736 alone; MEDI4736 plus tremelimumab; or standard treatment (cetuximab, 5-fluorouracil, cisplatin, and/or carboplatin). All treatments are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must:

  • Have squamous cell carcinoma of the head and neck that has come back or spread.
  • Not have had prior systemic therapy for recurrent or metastatic disease.
  • Have an ECOG status of 0 or 1.
  • Be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Shrujal Baxi at 646-888-4236.

Protocol

16-1108

Phase

III

Investigator

Co-Investigators