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 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