At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 794 enrolled
Drug / intervention
Nivolumab +1 moredrug
Likely dose
Nivolumab - dose and schedule to be specified per protocolAI-extracted
Key inclusion· 3
- ✓Stage II/III carcinoma of the esophagus or gastroesophageal junction
- ✓Completed preoperative chemoradiotherapy followed by surgery
- ✓Residual pathologic disease after complete resection with negative margins
Key exclusion· 4
- ✕Cervical esophageal carcinoma
- ✕Stage IV resectable disease
- ✕Did not receive concurrent chemoradiotherapy prior to surgery
- ✕Live or attenuated vaccine within 30 days of first treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
In Brief
A Phase 3 clinical trial evaluating Nivolumab and Placebo for Advanced Cancer. Completed, enrolled 794 participants across 204 sites in 31 countries.
Detailed Summary
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancer
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Peru, Poland, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsOno Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJul 2016
Primary CompletionMay 2020
Study CompletionNov 2024
TodayJul 2026
First PostedApr 19, 2016
Enrollment StartJul 14, 2016
Primary CompletionMay 12, 2020
Study CompletionNov 7, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.2 years ago
Interventions
Nivolumabdrug
Specified dose on specified days
Placeboother
Specified dose on specified days