An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
Purpose
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Condition
- Advanced Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Nivolumab |
|
|
|
Placebo Comparator Placebo |
|
More Details
- Status
- Unknown status
- Sponsor
- Bristol-Myers Squibb