A Study of Durvalumab (MEDI4736) in Esophageal Cancer

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Shadia Jalal, MD
Study ID
NCT02639065
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 27, 2016
Status verified
Sep 2023
Primary completion
Dec 9, 2020
Completion
Jun 9, 2021

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Treatment
    Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.

Primary Outcome Measure

Percentage of Participants With One-Year Relapse Free Survival (RFS) With Post-Operative Durvalumab [ Time Frame: From the date of surgery until disease relapse or death up to a maximum of 40 months. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Unversity of Iowa Hospital and ClinicsIowa CityIowa52242-
University of Michigan Health SystemAnn ArborMichigan48109-

Find similar trials in Indianapolis, IN

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Indiana University Melvin and Bren Simon Cancer Center· Indianapolis, INUnversity of Iowa Hospital and Clinics· Iowa City, IAUniversity of Michigan Health System· Ann Arbor, MI

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