Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC

Active:	No
Cancer Type:	Esophogeal Cancer Unknown Primary	NCT ID:	NCT04550260
Trial Phases:	Phase III	Protocol IDs:	D910SC00001 (primary) NCI-2021-11850
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT04550260

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.

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