NCT02639065

A Study of Durvalumab (MEDI4736) in Esophageal Cancer

A Phase II Study Evaluating Safety and Efficacy of Durvalumab (MEDI4736) Following Multi-modality Therapy in Esophageal Cancer: Big Ten Cancer Research Consortium BTCRC-ESO14-012

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Shadia Jalal, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.

Timeline

• Start date: 2016-04-27
• Primary completion: 2020-12-09
• Completion: 2021-06-09
• First posted: 2015-12-24
• Last updated: 2023-09-25
• Results posted: 2022-06-01

Locations

3 sites across 1 country: United States