Advanced Head and Neck Cancer

Clinical Research Study

Despite recent medical advancements in treating advanced head and neck cancer, current treatments are often limited in their ability to significantly slow or stop disease progression. In an effort to potentially help develop the next generation of immune therapy options, we’re conducting a new clinical research study for people with head and neck cancer—and you may be eligible to participate.

This clinical research study is for people whose head and neck cancer has returned or metastasized. This immune therapy study is evaluating an investigational gene therapy combined with an FDA-approved immune therapy. The combined treatment is designed to help the body’s immune system fight back against head and neck cancer, which may improve the body’s antitumor response and slow disease progression.

A Potential New Approach through an Investigational Immune Gene Therapy

One of the most common causes of tumor growth and treatment resistance is due to a problem with the body’s tumor-fighting genes—specifically, a tumor suppressor gene called p53. This gene is responsible for making sure cells in the body do not grow or divide too fast. It also helps alert other genes in the immune system to identify and attack tumorous cells.


The therapy is made up of:

Investigational gene therapy (Ad-p53): A gene therapy designed to reverse resistance to cancer immunotherapies by reintroducing normal p53 genes into affected tumors.

Opdivo® (nivolumab): An FDA-approved immunotherapy used to treat head and neck cancer.

Every eligible study participant will receive the investigational combination therapy.
There is no placebo in this clinical research study.

Study Overview


Study Treatment

Up to three cycles of the investigational combination therapy (28 days per cycle)

Short-term follow-up period (28 days after the last treatment cycle)

Long-term follow-up visits (every two months) while on study therapy


Key Eligibility Criteria

Diagnosed with recurrent or metastatic head and neck squamous cell carcinoma


All Eligible Study Participants Will Receive at No Cost:

Investigational gene therapy

Comprehensive study-related health evaluations and assessments

Study-related care and study visits