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

Study results available
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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

Nivolumab

Specified dose on specified days

BIOLOGICAL

Ipilimumab

Specified dose on specified days

DRUG

Cisplatin

Specified dose on specified days

DRUG

Fluorouracil

Specified dose on specified days

Sponsors & Collaborators

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143153 on ClinicalTrials.gov