A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
Overview
- Phase
- Phase 3
- Intervention
- Nivolumab
- Conditions
- Advanced Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 794
- Locations
- 204
- Primary Endpoint
- Disease-free Survival (DFS)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Investigators
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
Arms & Interventions
Nivolumab
Intervention: Nivolumab
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Disease-free Survival (DFS)
Time Frame: From randomization to the date of recurrence or death (up to approximately 46 months)
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
Secondary Outcomes
- Overall Survival (OS)(From randomization to the date of death (up to approximately 60 months))
- Overall Survival Rates at 12-, 24-, and 36-months(At 12-, 24- and 36-months post first dose.)