Brief Summary
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Brief Title
An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Advanced Cancer
Eligibility Criteria
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
* 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
Inclusion Criteria
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
Inclusion/
* 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
Inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02743494
Org Class
Industry
Org Full Name
Bristol-Myers Squibb
Org Study Id
CA209-577
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
Primary Outcomes
Outcome Description
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
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
Outcome Measure
Disease-free Survival (DFS)
Outcome Time Frame
From randomization to the date of recurrence or death (up to approximately 46 months)
Secondary Ids
Secondary Id
2015-005556-10
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
From randomization to the date of death (up to approximately 46 months)
Outcome Measure
Overall Survival (OS)
Outcome Description
Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization
Outcome Time Frame
From randomization to 1, 2 and 3 years later
Outcome Measure
Overall Survival Rate
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ana Acuna-Villaorduna
Investigator Email
aacunavi@montefiore.org
Investigator Phone