A Phase I/II Study of BYL719 plus Cetuximab in Patients with Recurrent or Metastatic Head and Neck Cancer

Full Title

A Phase Ib Dose Escalation/Randomized Phase II, Multicenter, Open-label Study of BYL719 in Combination with Cetuximab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma


Cetuximab is a drug used to treat head and neck cancer. It works by blocking a protein called the epidermal growth factor receptor and preventing cancer cells from receiving the message to grow and multiply. In this study, researchers want to determine if adding an investigational drug called BYL719 to cetuximab treatment is more effective than cetuximab alone for treating head and neck cancers that have come back or spread after prior therapy.

BYL719 is an inhibitor of PI3 kinase, an enzyme which fuels the growth of several types of cancer. It is taken orally (by mouth). Cetuximab is given intravenously (by vein). Patients in this study will be randomly assigned to receive cetuximab plus BYL719 (two-thirds of the patients) or cetuximab alone (the remaining one-third of patients).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have head and neck cancer that came back or spread after prior therapy.
  • Patients must have previously received cisplatin or be deemed ineligible for this therapy by their doctors due to possible side effects.
  • Patients must have recovered from the serious side effects of prior therapies.
  • Patients may not have previously received PI3 kinase inhibitors.
  • This study is open to patients age 18 and older.

For more information and to see if you are eligible for this study, please contact Dr. David Pfister at 646-888-4232.