A Phase II Study of Cobimetinib plus Atezolizumab Immunotherapy in Patients Metastatic or Inoperable Head and Neck Cancer

Full Title

WO39760: A Phase II, Open-Label, Multicenter, Multicohort Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Patients with Solid Tumors

Purpose

The purpose of this study is to assess the safety and effectiveness of combining two drugs in patients with head and neck cancer that has come back despite prior therapy and which spread or cannot be surgically removed. The drugs are cobimetinib and atezolizumab.

Cobimetinib works by inhibiting MEK, a protein which fuels cancer growth. It may also strengthen the immune system’s ability to fight cancer. It is used to treat melanoma; its use in this study is considered investigational. Cobimetinib is taken orally (by mouth).

Atezolizumab is an immunotherapy drug designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. It is approved for treating bladder and lung cancers; its use in this study is investigational. Atezolizumab is given intravenously (by vein).

Eligibility

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

  • Patients must have metastatic or inoperable head and neck squamous cell carcinoma that has come back despite prior treatment.
  • At least 2 weeks must pass since the completion of previous therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eric Sherman at 646-888-4234.

Protocol

17-571

Phase

II

Investigator

Co-Investigators