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Status unknownNCT02520453Updated Dec 9, 2019

Adjuvant Durvalumab for Esophageal Cancer

A Phase 2 interventional study of Durvalumab and Placebo in Esophageal Cancer, sponsored by Samsung Medical Center. Status unknown at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.

Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.

02

Conditions studied

  • Esophageal Cancer
03

In context

Esophageal Neoplasms

1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.

This study's enrollment of 86 is above the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Browse Samsung Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically confirmed squamous esophageal cancer, irrespective of PD-L1 status
  • The enrolment should be done during the time interval from 20 days to 56 days after complete resection after neoadjvuant CCRT (no residual tumor after operation)
  • Clinical tumor stage before neoadjuvant CCRT should be T3-4N0M0 or T1-4N1-3M0
  • Available tumor specimen for biomarker analysis acquired before neoadjuvant CCRT or at operation

Exclusion criteria

Exclusion Criteria:

  • Other PD-1 or PD-L1 inhibitors history
  • Mean QT interval corrected for heart rate (QTc) ≥470 ms using Bazett's correction
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
  • Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Durvalumab

    Durvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity

    Drug: Durvalumab

  • Placebo comparator
    Placebo

    Placebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Disease-free survival

    Time frame: 1 year

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, MA 02445, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02520453
Lead sponsor
Samsung Medical Center
Responsible party
Jong-Mu Sun (Assistant Professor, Samsung Medical Center) — Principal investigator
First posted
Aug 11, 2015
Start date
Feb 2016
Primary completion
Jun 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Dec 9, 2019

Study contacts

Jong-Mu Sun
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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