Phase 3
N=419
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02569242 ↗Enrolled (actual)
419
Serious AEs
34.8%
Results posted
Jan 2022
Primary outcome: Primary: Overall Survival — 10.9; 8.4 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Drug); Docetaxel/Paclitaxel (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Ono Pharmaceutical Co., Ltd.
- Primary completion
- Oct 2020
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 | — |
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.
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). 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.