Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
Esophogeal Cancer
Unknown Primary
18 Years and older, Male and Female
D910SC00001 (primary)
NCI-2021-11850
Summary
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).
Objectives
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.
Eligibility
- 18 years or older at the time of signing the ICF.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).
- Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.
- Patients with at least an evaluable lesion per RECIST 1.1.
- Mandatory provision of available tumor tissue for PD-L1 expression analysis.
- ECOG PS 0 or 1.
- Adequate organ and marrow function.
- Life expectancy of more than 3 months.
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