Study on Immunoradiotherapy Before Surgery for Head and Neck Cancer
Sponsor: Providence Health & Services
ClinicalTrials ID:NCT04938609
This clinical trial is testing a new treatment approach that combines immunotherapy and radiation therapy before surgery to see if it can effectively treat stage III and IVA head and neck cancer that is not caused by HPV.
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Program Overview
The aim of this study is to evaluate whether using a combination of immunotherapy (pembrolizumab) and radiation therapy before surgery can safely and effectively treat patients with stage III and IVA head and neck squamous cell carcinoma (HNSCC) that is not linked to HPV. Researchers will also collect samples to study immune responses and other health markers. The study will last about 52 weeks, with treatment starting at week 7, followed by additional therapy as needed. Patients will receive pembrolizumab every 3 weeks for a total of 17 doses. The study will assess how well this approach works in reducing the cancer stage before surgery and improving patient outcomes.
Description
This clinical trial is exploring a new treatment method for head and neck cancer that involves using pembrolizumab, an immunotherapy drug, along with radiation therapy before surgery. The main goal is to determine if this combination is safe and effective in treating head and neck squamous cell carcinoma (HNSCC) that is not caused by HPV. Researchers will collect tumor tissue, microbiome samples, and blood to study immune responses and other health markers.
The study will last approximately 52 weeks. Patients will receive the immunoradiotherapy treatment around week 7, followed by surgery and additional therapy as needed. Pembrolizumab will be administered every 3 weeks for a total of 17 doses. The study aims to see if this approach can reduce the cancer stage before surgery, improve quality of life, and enhance local control and overall survival. Patients will be monitored for disease-free and overall survival for up to 5 years.
The study will enroll eligible patients unless there is a high rate of surgical delays due to the treatment. It is estimated that at least 2 patients will be enrolled per month, with full enrollment expected to take about 2.5 years.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with stage III-IVA HPV-negative head and neck squamous cell carcinoma (HNSCC) and planned for surgery.
- Men must agree to use contraception during treatment and for a specified period after the last dose.
- Women must not be pregnant or breastfeeding and must agree to use contraception if of childbearing potential.
- Must provide written informed consent.
- Must provide a recent tumor tissue sample for analysis.
- Must have a performance status score of 0 or 1, indicating good overall health.
- Must have adequate organ function as determined by specific medical tests.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Previous treatment with certain immunotherapy drugs.
- Recent cancer treatments, including chemotherapy or radiation to the head and neck.
- Recent live vaccinations.
- Participation in another clinical trial within the past 4 weeks.
- Immunodeficiency or use of immunosuppressive therapy.
- Other active cancers requiring treatment within the past 2 years.
- Active brain metastases or meningitis.
- Severe allergies to pembrolizumab.
- Active autoimmune diseases requiring treatment.
- History of lung diseases like pneumonitis.
- Active infections requiring treatment.
- History of HIV, Hepatitis B, or Hepatitis C.
- History of tuberculosis.
- Any condition that may interfere with the study.
- Psychiatric or substance abuse disorders affecting participation.
- Patients with certain types of larynx cancer.
- History of organ transplantation.
- Pre-existing severe neuropathy.
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