Description:
The primary purpose of this study is to determine whether Nivolumab will improve disease-free
survival compared with placebo.
Title
- Brief Title: An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
- Official Title: A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
Clinical Trial IDs
- ORG STUDY ID:
CA209-577
- SECONDARY ID:
2015-005556-10
- NCT ID:
NCT02743494
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | | Nivolumab |
Purpose
The primary purpose of this study is to determine whether Nivolumab will improve disease-free
survival compared with placebo.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Nivolumab | Experimental | | |
| Placebo | Placebo Comparator | | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Disease-free Survival (DFS) |
| Time Frame: | From randomization to the date of recurrence or death (up to approximately 46 months) |
| Safety Issue: | |
| 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 |
Secondary Outcome Measures
| Measure: | Overall Survival (OS) |
| Time Frame: | From randomization to the date of death (up to approximately 46 months) |
| Safety Issue: | |
| 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. |
| Measure: | Overall Survival Rate |
| Time Frame: | From randomization to 1, 2 and 3 years later |
| Safety Issue: | |
| Description: | Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
June 22, 2021
