Description:
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Active, not recruiting
Phase 3
Drug | Synonyms | Arms |
---|---|---|
Nivolumab | Nivolumab |
Name | Type | Description | Interventions |
---|---|---|---|
Nivolumab | Experimental | Specified dose on specified days. |
|
Placebo | Placebo Comparator | Specified dose on specified days. |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Disease-Free Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery |
Time Frame: | Approximately 36 months after the first subject is randomized |
Safety Issue: | |
Description: |
Measure: | Overall survival rate |
Time Frame: | Overall survival rate at 1, 2, and 3 years |
Safety Issue: | |
Description: |
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
September 1, 2017