This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. After six patients are treated with at least one dose of study drug, they will be observed for a minimum of 60 days. During the 60-day observation period, further accrual will be halted to evaluate "unacceptable toxicities warranting early closure of the trial" defined as: * Any definitive durvalumab-related death. A durvalumab-related death will be continuously monitored throughout the trial and the trial will be suspended for re-evaluation whenever such an event is confirmed. * Any unexpected and previously unreported grade 4 toxicities definitely related to durvalumab.
OUTLINE: This is a multi-center trial. INVESTIGATIONAL TREATMENT: Subjects will receive durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence. The following baseline labs must be completed within 28 days prior to registration for protocol therapy: Hematopoietic: * White blood cell count (WBC) \> 3 K/mm\^3 * Hemoglobin (Hgb) \> 9 g/dL. Transfusion is allowed, if needed, since patients are post esophagectomy. * Platelets \> 100 K/mm\^3 * Absolute neutrophil count (ANC) ≥ 1.5 K/mm\^3 Renal: * Calculated creatinine clearance of \>/= 40 cc/min using the Cockcroft-Gault formula or by 24-hour urine collection. Hepatic: * Bilirubin ≤ 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST, SGOT) \</= 2.5 x ULN * Alanine aminotransferase (ALT, SGPT) \</= 2.5 x ULN
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Unversity of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Percentage of Participants With One-Year Relapse Free Survival (RFS) With Post-Operative Durvalumab
Relapse free survival is defined as time from the date of surgery until the criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started The percentage of subjects who attained relapse free survival for 1 year and 95 % confidence interval has been reported here.
Time frame: From the date of surgery until disease relapse or death up to a maximum of 40 months.
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
One of the secondary objective in this study is to assess toxicity and tolerability of durvalumab following trimodality therapy in patients with esophageal cancer. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks. Adverse Event severity grades can be described as follows : * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death
Time frame: From the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months.
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