A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT03143153
- Phase
- PHASE3
- Status
- Completed
Conditions
- Various Advanced Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — BIOLOGICALSpecified dose on specified days
- Ipilimumab — BIOLOGICALSpecified dose on specified days
- Cisplatin — DRUGSpecified dose on specified days
- Fluorouracil — DRUGSpecified dose on specified days
Study Details
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
Key Dates
- Start date
- Jun 29, 2017
- Status verified
- Feb 2026
- Primary completion
- Jan 18, 2021
- Completion
- Jan 13, 2025
Study Design
- Enrollment
- 970 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab + Ipilimumab
- Experimental: Nivolumab + Cisplatin + Fluorouacil
- Active Comparator: Cisplatin + Fluorouracil
Primary Outcome Measure
Overall Survival (OS) in Participants With Tumor Cell PD-L1 [ Time Frame: From the date of randomization to up to the date of death (up to approximately 20 months) ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0191 | Mobile | Alabama | 36608 | - |
| Arizona Cancer Center | Tucson | Arizona | 85724 | - |
| Usc/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | - |
| Local Institution - 0188 | Denver | Colorado | 80218 | - |
| Local Institution - 0186 | Miami | Florida | 33176 | - |
| University Of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | - |
| Local Institution - 0225 | Tampa | Florida | 33612 | - |
| Local Institution - 0074 | Atlanta | Georgia | 30322 | - |
| Local Institution - 0032 | Marietta | Georgia | 30060 | - |
| Hackensack Meridian Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | - |
| Oncology Associates Of Oregon, Pc | Eugene | Oregon | 97401 | - |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | - |
| Local Institution - 0210 | Dallas | Texas | 75246 | - |
| Local Institution - 0028 | Houston | Texas | 77030 | - |
| Local Institution - 0190 | Roanoke | Virginia | 24014 | - |
| Local Institution - 0203 | Morgantown | West Virginia | 26506-9162 | - |