Summary:
Advanced Head and Neck Cancer Clinical Research Study – University of Toledo Medical Center
When Head and Neck Cancer Returns…
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.
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 immune system – 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.
Study Overview
This clinical research study is for people whose head and neck cancer has returned. This immune therapy study is evaluating an investigational combination therapy designed to help the body’s immune system fight back against head and neck cancer, which may improve the body’s anti-tumor response and slow disease progression.
The investigational combination therapy is made up of:
- Investigational gene therapy (Ad-p53): A gene therapy designed to reverse resistance to cancer immunotherapies by re-introducing 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 Design
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)
Key Eligibility Criteria
- Diagnosed with recurrent head and neck squamous cell carcinoma
- Cancer has not spread to the brain
- No other significant / uncontrolled medical issues
All Eligible Study Participants Will Receive At No Cost:
- Investigational combination therapy
- Comprehensive study-related health evaluations and assessments
- Study-related care and study visits
To Learn More, Contact the University of Toledo Medical Center:
Eleanor N. Dana Cancer Center
Phone: (419) 383-6962