An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

Status: Closed to Accrual

Description

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
  • Completed pre-operative chemo radiotherapy followed by surgery
  • Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection

Exclusion Criteria

  • Diagnosed with cervical esophageal carcinoma
  • Diagnosed with Stage IV resectable disease
  • Did not receive concurrent chemoradiotherapy prior to surgery
  • Participants who have received a live/attenuated vaccine within 30 days of the first treatment

Locations & Contacts

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Active
Name Not Available

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Daniel Virgil Thomas Catenacci
Phone: 773-834-0475

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Ronan Joseph Kelly
Phone: 410-502-3696

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Approved
Contact: James Mark Cleary
Phone: 617-632-9265
Brigham and Women's Hospital
Status: Active
Contact: James Mark Cleary
Phone: 877-442-3324
Email: jcleary@partners.org
Dana-Farber Cancer Institute
Status: Active
Contact: James Mark Cleary
Phone: 617-632-5588
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Contact: Hope Elizabeth Uronis
Phone: 919-668-1861

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-577
Secondary IDs NCI-2016-00858, 2015-005556-10, s16-00474
Clinicaltrials.gov ID NCT02743494