Clinical Trials Study

Phase 3

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

Conditions: ADVANCED CANCER

Study #:
NCT02743494
Last Updated:
11/18/2025
Recruitment Status:
Completed
Estimated Study Completion Date:
11/07/2024

Summary

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

Age: 18 Years and older

Gender: All

Start Date: 07/14/2016

Primary Completion Date (Estimated): 05/12/2020

Study Completion Date (Estimated): 11/07/2024

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

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

Other protocol defined Inclusion/exclusion criteria could apply

Principal Investigator

Ana Acuna-Villaorduna

For more information about this study, contact:

Ana Acuna-Villaorduna

aacunavi@montefiore.org