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Adjuvant Durvalumab for Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Durvalumab
Placebo
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Durvalumab

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Full Information

First Posted
August 4, 2015
Last Updated
December 5, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02520453
Brief Title
Adjuvant Durvalumab for Esophageal Cancer
Official Title
Randomised, Double-blind, Phase II Trial of Adjuvant Durvalumab or Placebo for Completely Resected Esophageal Squamous Cell Carcinoma Previously Treated With Neoadjuvant Concurrent Chemoradiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Durvalumab
Arm Type
Experimental
Arm Description
Durvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Mu Sun
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
MA
ZIP/Postal Code
02445
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Adjuvant Durvalumab for Esophageal Cancer

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