At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 970 enrolled
Drug / intervention
Nivolumab +3 morebiological
Likely dose
Not stated in record
Key inclusion· 5
- ✓Histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
- ✓Age ≥18 years
- ✓Advanced, recurrent, or metastatic esophageal cancer that cannot be surgically resected or treated with definitive chemoradiation with curative intent
- ✓Able to walk and carry out light activities (light housework or office work) or better
Key exclusion· 5
- ✕Symptomatic brain or spinal cord metastases or those requiring treatment
- ✕Active or suspected autoimmune disease
- ✕Serious or uncontrolled medical disorder or active infection
- ✕Known history of HIV or AIDS
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 2 other interventions for Various Advanced Cancer. Completed, enrolled 970 participants across 190 sites in 27 countries.
Detailed Summary
The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVarious Advanced Cancer
CountriesArgentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, France, Hong Kong, Italy, Japan, Mexico, Peru, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsOno Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartJun 2017
Primary CompletionJan 2021
Study CompletionJan 2025
TodayJul 2026
First PostedMay 8, 2017
Enrollment StartJun 29, 2017
Primary CompletionJan 18, 2021
Study CompletionJan 13, 2025
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.2 years ago
Interventions
Nivolumabbiological
Specified dose on specified days
Ipilimumabbiological
Specified dose on specified days
Cisplatindrug
Specified dose on specified days
Fluorouracildrug
Specified dose on specified days