Phase 3
Completed N=794
An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
Source: ClinicalTrials.gov NCT02743494 ↗Enrolled (actual)
794
Serious AEs
37.3%
Results posted
Jun 2021
Primary outcomePrimary: Disease-free Survival (DFS) — 22.41; 11.04 Months — p=0.0003
◆ Published Evidence
Highly cited
1,769citations · ~354 / year
Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.
Summary
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Linked Publications
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Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival (DFS) |
22.41; 11.04 | 0.0003 sig |
| SECONDARY Overall Survival (OS) |
51.71; 35.25 | 0.1064 |
| SECONDARY Overall Survival Rates at 12-, 24-, and 36-months |
87.5; 84.6; 68.1; 65.8; 56.9; 49.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT02743494) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.