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
NCT03143153 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 970
Last updated 2026-02-17
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
Conditions
- Various Advanced Cancer
Interventions
- BIOLOGICAL
-
Specified dose on specified days
- BIOLOGICAL
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
Ono Pharmaceutical Co. Ltd
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-29
- Primary Completion
- 2021-01-18
- Completion
- 2025-01-13
- FDA Drug
- Yes
Countries
- United States
- Argentina
- 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
Study Locations
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