Adjuvant Durvalumab for Esophageal Cancer
Randomised, Double-blind, Phase II Trial of Adjuvant Durvalumab or Placebo for Completely Resected Esophageal Squamous Cell Carcinoma Previously Treated With Neoadjuvant Concurrent Chemoradiotherapy
1 other identifier
interventional
86
1 country
1
Brief Summary
Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 9, 2019
December 1, 2019
5.3 years
August 4, 2015
December 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival
1 year
Study Arms (2)
Durvalumab
EXPERIMENTALDurvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Placebo
PLACEBO COMPARATORPlacebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, MA, 02445, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong-Mu Sun
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 4, 2015
First Posted
August 11, 2015
Study Start
February 1, 2016
Primary Completion
June 1, 2021
Study Completion
December 1, 2021
Last Updated
December 9, 2019
Record last verified: 2019-12