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

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

Official Title
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A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: Nivolumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab<br> | Drug: Nivolumab<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival (DFS) | Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first. Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment | From randomization to the date of recurrence or death (up to approximately 46 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or last known alive date). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up. | From randomization to the date of death (up to approximately 46 months) | 
| Overall Survival Rate | Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization | From randomization to 1, 2 and 3 years later |