Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN

The purpose of this study is to investigate other drugs that may be combined with radiation to treat cancer. The study focuses on determining whether a combination of durvalumab with radiation can both improve cure rate and at the same time have less serious side effects. Throughout this document, this investigational drug will be referred to as the "study drug", or named individually (durvalumab). The study drug in this research is referred to as investigational because the U.S. Food and Drug Administration (FDA) has not yet approved itfor the treatment of head and neck cancer. Durvalumab was FDA approved in 2017 for the treatment of certain types of bladder cancer, but has not been approved for use in Head and Neck cancer patients. Durvalumab is an experimental drug that uses the body's immune system to fight the cancer. This study drug is being used in other ongoing clinical trials for other types of cancers. The doctor feels that a patient may experience fewer side effects using this study drug with radiation rather than using cisplatin. The doctor is also investigating whether using this drug can increase the effectiveness of treatment.

NCT Number	NCT03529422
Lead Sponsor	UNC Lineberger Comprehensive Cancer Center Collaborators: AstraZeneca
Conditions	Larynx, Lip, Oral Cancer, Digestive Organs--Diseases
Enrollment	18 participants
Start Date	2019-10-07
Primary Completion	2024-07-01 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-23