NCT02520453UnknownPhase 2
Randomised, Double-blind, Phase II Trial of Adjuvant Durvalumab or Placebo for Completely Resected Esophageal Squamous Cell Carcinoma Previously Treated With Neoadjuvant Concurrent Chemoradiotherapy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Samsung Medical Center
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Disease-free survival
Study Overview
Brief Summary
Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Durvalumab
Experimental
Durvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Intervention: Durvalumab (Drug)
Placebo
Placebo Comparator
Placebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Jong-Mu Sun
Assistant Professor
Samsung Medical Center
Study Sites (1)
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