A Study of Durvalumab (MEDI4736) in Esophageal Cancer
Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Shadia Jalal, MD
Collaborators:
AstraZeneca Big Ten Cancer Research Consortium Hoosier Cancer Research Network MedImmune LLC