At a glance
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A Phase II Study of Durvalumab (MEDI 4736) With Radiotherapy for the Adjuvant Treatment of Intermediate Risk Head and Neck Squamous Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Durvalumab and Intensity Modulated Radiotherapy Treatments for Larynx and 3 related conditions. Active but no longer recruiting, targeting 18 participants across 3 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments
Interventions
Durvalumab 1500mg IV every 3 weeks for 6 cycles
Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks