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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
AstraZeneca
Study ID
NCT04550260
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab intravenous infusion
  • Placebo — DRUG
    Durvalumab matching placebo for intravenous infusion
  • cisplatin + fluorouracil — DRUG
    cisplatin + fluorouracil, as per Standard of Care
  • cisplatin + capecitabine — DRUG
    cisplatin + capecitabine, as per Standard of Care
  • Radiation — RADIATION
    50-64Gy in total

Study Details

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).

Key Dates

Start date
Oct 19, 2020
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
640 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Durvalumab + definitive CRT
    Durvalumab + concurrent chemoradiation
  • Placebo Comparator: Arm 2: Placebo + definitive CRT
    Placebo + concurrent chemoradiation

Primary Outcome Measure

Progression free survival (PFS) per RECIST 1.1 as assessed by BICR [ Time Frame: up to approximately 56 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteAtlantaGeorgia30308-
Research SiteLouisvilleKentucky40217-
Research SiteDallasTexas75390-
Research SiteFairfaxVirginia22031-
Research SiteMorgantownWest Virginia26506-

Find similar trials in Atlanta, GA

By research site
Research Site· Atlanta, GAResearch Site· Louisville, KYResearch Site· Dallas, TXResearch Site· Fairfax, VAResearch Site· Morgantown, WV

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