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
Terminated
Date Opened To Accrual
December 12 2017
Date Closed to Accrual
September 01 2022
Date of Study Termination
September 04 2025
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.