Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin
Principal Investigator
Loren Mell, MD
Status
Closed to Accrual & Treatment
Date Opened To Accrual
December 12 2017
Date Closed to Accrual
September 01 2022
Disease Site
Head and Neck [HN]
Head and Neck
Phase
II/III
Developmental Therapeutics
No
Primary Objective
Lead-In: To determine the safety of radiotherapy (RT) with concurrent and adjuvant anti-PD-L1 therapy [MEDI4736 (durvalumab)] is safe in patients with locoregionally advanced head and neck cancer (HNC) who have a contraindication to cisplatin.
Phase II: To test the hypothesis that concurrent RT and anti-PD-L1 therapy improves PFS compared to standard therapy (RT with concurrent cetuximab) in patients with locoregionally advanced HNC who have a contraindication to cisplatin.
Phase III: To test the hypothesis that concurrent RT and anti-PD-L1 therapy improves overall survival compared to standard therapy (RT with concurrent cetuximab) in patients with locoregionally advanced HNC who have a contraindication to cisplatin
Patient Population
Pathologically confirmed, previously untreated, unresected locoregionally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or carcinoma of unknown head/neck primary, with contraindication to cisplatin.
Target Accrual
454
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.