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