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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

ArmDescriptionAssigned Intervention
Experimental
Nivolumab
  • Drug: Nivolumab
    Specified dose on specified days
Placebo Comparator
Placebo
  • Other: Placebo
    Specified dose on specified days

More Details

Status
Active, not recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.