NCT03143153 · OUTCOME

Overall Survival (OS) in All Randomized Participants

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 · Source last updated 2026-02-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From the date of randomization to up to the date of death (up to approximately 88 months)

What was measured

Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.

Analysis population: All randomized participants

Groups in this outcome

Arm A: Nivolumab + Ipilimumab

Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.

Arm B: Nivolumab + Chemotherapy

Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.

Arm C: Chemotherapy

Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Arm A: Nivolumab + Ipilimumab	325
Arm B: Nivolumab + Chemotherapy	321
Arm C: Chemotherapy	324

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Nivolumab + Ipilimumab	12.747	Not reported	11.269	15.474	Not reported
Arm B: Nivolumab + Chemotherapy	13.207	Not reported	11.105	15.671	Not reported
Arm C: Chemotherapy	10.710	Not reported	9.396	12.090	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.65
ci Pct Value
95
ci Upper Limit
0.92
estimate Comment
Stratified Cox proportional hazard model
group Description
Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.77
ci Lower Limit
0.65
ci Pct Value
95
ci Upper Limit
0.92
estimate Comment
Stratified Cox proportional hazard model
group Description
Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.77

Complete source fields

analyses

ci Lower Limit
0.65
ci Pct Value
95
ci Upper Limit
0.92
estimate Comment
Stratified Cox proportional hazard model
group Description
Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.77
ci Lower Limit
0.65
ci Pct Value
95
ci Upper Limit
0.92
estimate Comment
Stratified Cox proportional hazard model
group Description
Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.77

classes

categories
measurements
group Id
OG000
lower Limit
11.269
upper Limit
15.474
value
12.747
group Id
OG001
lower Limit
11.105
upper Limit
15.671
value
13.207
group Id
OG002
lower Limit
9.396
upper Limit
12.090
value
10.710

denoms

counts
group Id
OG000
value
325
group Id
OG001
value
321
group Id
OG002
value
324
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
id
OG000
title
Arm A: Nivolumab + Ipilimumab
description
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
id
OG001
title
Arm B: Nivolumab + Chemotherapy
description
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
id
OG002
title
Arm C: Chemotherapy

param Type

MEDIAN

population Description

All randomized participants

reporting Status

POSTED

time Frame

From the date of randomization to up to the date of death (up to approximately 88 months)

title

Overall Survival (OS) in All Randomized Participants

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice