Study on Immunotherapy and Radiation Before Surgery for Head and Neck Cancer
Sponsor: Providence Health & Services
ClinicalTrials ID:NCT03247712
This clinical trial is testing a new approach that combines immunotherapy and radiation before surgery to see if it can safely reduce the size of head and neck tumors, making them easier to remove.
Patient Parameters
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Program Overview
The aim of this study is to evaluate if using a combination of immunotherapy (nivolumab) and radiation therapy before surgery can safely shrink tumors in patients with Head and Neck Squamous Cell Carcinoma (HNSCC). This approach, called neoadjuvant immunoradiotherapy, is being tested to see if it can make surgery more effective by reducing the tumor size beforehand.
Description
This clinical trial involves using the drug nivolumab along with radiation therapy before surgery to treat patients with Head and Neck Squamous Cell Carcinoma (HNSCC). The main goal is to determine if this combination is safe and feasible before surgery. Researchers will also collect samples from the tumor, microbiome, and blood to study immune responses. This is the first study to test the safety and effectiveness of using radiation and PD-1 blockade before surgery in HNSCC patients.
The study is expected to last about 20 weeks, starting with immunoradiotherapy and possibly surgery, followed by six doses of nivolumab given every four weeks. Some patients may also receive additional therapy based on their risk, following standard care practices.
The study has two phases: Phase I will involve six patients to assess safety, and Phase II will involve 28 patients to evaluate how well the treatment reduces tumor size. If the initial phase shows that the treatment is safe, the study will continue to the second phase. Patients will be monitored for five years to track their survival and disease progression.
Eligible patients can join the study unless more than 33% experience unplanned surgical delays due to the treatment. The study aims to enroll 10 to 20 patients each year.
Eligibility Criteria
Inclusion Criteria
- Patients with squamous cell carcinoma of the head and neck who are planned for surgery and can safely receive immunotherapy and radiation before surgery.
- Patients with HPV-positive or HPV-negative status, as determined by specific tests.
- Age 18 or older, able to give informed consent, and comply with the study requirements.
- Good overall health as determined by specific performance status criteria.
- Recent laboratory tests showing adequate blood cell counts and organ function.
- Women of childbearing potential must agree to use effective birth control during treatment and for a specified period after.
- Men must agree to use effective birth control during treatment and for a specified period after.
Exclusion Criteria
- Any medical conditions like bleeding, active infections, or psychiatric issues that would make participation unsafe.
- Head and neck cancer cases where radiation is not part of the normal treatment plan.
- Need for long-term use of high-dose oral steroids.
- History of or current active autoimmune diseases that pose a significant health risk, except for certain controlled conditions like vitiligo or hypothyroidism.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Portland Medical Center | 97213 | Portland | Oregon |
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