Phase 3
Completed N=419
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
Source: ClinicalTrials.gov NCT02569242 ↗Enrolled (actual)
419
Serious AEs
34.8%
Results posted
Jan 2022
Primary outcomePrimary: Overall Survival — 10.9; 8.4 months
◆ Published Evidence
Highly cited
1,242citations · ~177 / year
Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial.
Summary
The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
Linked Publications
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Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
10.9; 8.4 | — |
| SECONDARY Progression-free Survival |
1.7; 3.4 | — |
| SECONDARY Duration of Response |
6.9; 3.9 | — |
Eligibility Criteria
Inclusion Criteria
- Men & women ≥20 years of age
- Histologically confirmed unresectable advanced or recurrent esophageal cancer
- Refractory to or intolerant of standard therapy
- ECOG Performance Status score 0 or 1
- A life expectancy of at least 3 months
Exclusion Criteria
- Current or past history of severe hypersensitivity to any other antibody products
- Patients with multiple primary cancers
- Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
- Patients with active, known or suspected autoimmune disease
Data sourced from ClinicalTrials.gov (NCT02569242) 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.