Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
86 participants
INTERVENTIONAL
2016-02-29
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Durvalumab
Durvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Durvalumab
Placebo
Placebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Placebo
Interventions
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Durvalumab
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Jong-Mu Sun
Assistant Professor
Principal Investigators
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Jong-Mu Sun
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, MA, South Korea
Countries
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Other Identifiers
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2015-06-166
Identifier Type: -
Identifier Source: org_study_id