This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).
Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in PD-L1 High population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
640
Durvalumab intravenous infusion
Durvalumab matching placebo for intravenous infusion
cisplatin + fluorouracil, as per Standard of Care
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
To assess the efficacy in terms of PFS in PD-L1 High population
Time frame: up to approximately 56 months
Overall survival (OS)
To assess the efficacy in terms of OS in all randomized patients and in PD-L1 High population until the date of death
Time frame: up to approximately 72 months
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
To assess the efficacy in terms of PFS in all randomized patients.
Time frame: up to approximately 56 months
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cisplatin + capecitabine, as per Standard of Care
50-64Gy in total
Research Site
Atlanta, Georgia, United States
Research Site
Louisville, Kentucky, United States
Research Site
Dallas, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Morgantown, West Virginia, United States
Research Site
Brussels, Belgium
Research Site
Charleroi, Belgium
Research Site
Liège, Belgium
Research Site
Namur, Belgium
Research Site
Barretos, Brazil
...and 123 more locations