At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 419 enrolled
Drug / intervention
Nivolumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ONO-4538 Phase III Study A Multicenter, Randomized, Open-label Study in Patients With Esophageal Cancer Refractory or Intolerant to Combination Therapy With Fluoropyrimidine and Platinum-based Drugs
In Brief
A Phase 3 clinical trial evaluating Nivolumab and Docetaxel/Paclitaxel for Esophageal Cancer. Completed, enrolled 419 participants across 89 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer
CountriesDenmark, Germany, Italy, Japan, South Korea, Taiwan, United Kingdom, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartDec 2015
Primary CompletionOct 2020
TodayJul 2026
First PostedOct 6, 2015
Enrollment StartDec 14, 2015
Primary CompletionOct 23, 2020
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.7 years ago
Interventions
Nivolumabdrug
Docetaxel/Paclitaxeldrug