Study on Durvalumab and Radiation Therapy for Treating Intermediate Risk Head and Neck Cancer

Program Overview

The study aims to find out if using durvalumab, an experimental drug that helps the immune system fight cancer, along with radiation therapy, can improve the chances of curing head and neck cancer. Durvalumab is not yet approved for this type of cancer, but it is being tested in other cancer trials. Researchers believe this combination might cause fewer side effects compared to the standard treatment with cisplatin.

Description

The main goal of this study is to see if patients with intermediate-risk head and neck cancer can live longer without the disease returning when treated with durvalumab and radiation therapy. Researchers will also look at the safety of this treatment by monitoring any serious side effects. They will study how well patients do over time and whether certain markers, like PD-L1 expression and HPV status, affect treatment success.

Patients will receive durvalumab and radiation therapy over three cycles, each lasting three weeks. Radiation will be given daily during weekdays for six weeks. After that, patients will continue with durvalumab alone for three more cycles, each lasting four weeks. The study will follow patients for up to five years to monitor their health and any side effects.

Inclusion Criteria:

• Must be 18 years or older and have signed a consent form.
• Have a confirmed diagnosis of squamous cell carcinoma of the head and neck.
• Have had surgery to remove the primary tumor within the last eight weeks.
• Meet specific criteria for intermediate risk of cancer returning.
• Have good organ function and a performance status of 0 or 1.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
• Men must agree to use contraception if they have female partners.

Exclusion Criteria:

• Currently in another clinical trial or have been in one recently.
• Have metastatic disease or are receiving other cancer treatments.
• Have had recent antibiotics or have allergies to durvalumab.
• Have used immunosuppressive medications recently.
• Have active infections or certain autoimmune diseases.
• Have a history of other cancers or serious health conditions that could interfere with the study.
• Have received a live vaccine recently.

Eligibility Criteria

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