Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin

Protocol No
NRG-HN004
Principal Investigator
Stuart Wong
Phase
II/III
Summary
The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment, MEDI4736 (durvalumab), to the usual therapy of radiation plus cetuximab in patients with head and neck cancer who cannot take the drug cisplatin. MEDI4736 (durvalumab) works by boosting your immune system to help recognize and to fight cancer. MEDI4736 (durvalumab) is FDA approved for cancer of the urinary system, but it is not approved for use with radiation therapy in head and neck cancer. The study treatment may or may not shrink your cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach (radiation and MEDI4736 (durvalumab) is better, the same, or worse than the usual approach. To be better, the study treatment should extend survival for the average patient by 8 months compared with the usual approach. There will be about 500 people taking part in this study.
Description
Comparing Radiation Plus Antibody Therapy to Radiation Plus Immune Therapy in People With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
Participating Institutions
Community Memorial Hospital
St. Joseph's Hospital - West Bend
Froedtert Hospital
Status
OPEN TO ACCRUAL
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