A Phase II Study of Nivolumab Immunotherapy with and without Stereotactic Radiation Therapy to Treat Patients with Metastatic Head and Neck Cancer

Full Title

A Phase II Randomized Controlled Screening Trial of Nivolumab with Image Guided, Stereotactic Body Radiotherapy (SBRT) versus Nivolumab Alone in Patients with Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Purpose

The purpose of this study is to evaluate the safety and effectiveness of nivolumab alone and with stereotactic radiation therapy in patients with advanced head and neck cancers. Nivolumab is a form of immunotherapy. It works by boosting an immune response against cancer. Stereotactic radiation therapy can also strengthen the immune response against cancer, and combining it with nivolumab may make this effect even stronger.

Nivolumab is approved for treating several types of cancer. It targets a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body's white blood cells. Nivolumab binds to and inactivates PD-1, enhancing the body's ability to detect and destroy cancer cells.

Patients in this study will be randomly assigned to receive nivolumab alone or nivolumab plus stereotactic radiation therapy. Nivolumab 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 head and neck squamous cell cancer (at least two lesions).
  • At least 2 weeks must pass since the completion of prior therapies and entry into the study (4 weeks since any prior anti-CTLA4 therapy). Patients may not have had prior anti-PD1 therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sean McBride at 212-639-5717.

Protocol

15-253

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators