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NCT03143153 · OUTCOME

Overall Survival (OS) in Participants With Tumor Cell PD-L1

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 20 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 PD-L1 expressing 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

GroupSource count
Arm A: Nivolumab + Ipilimumab158
Arm B: Nivolumab + Chemotherapy158
Arm C: Chemotherapy157

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab13.70Not reported11.2417.02Not reported
Arm B: Nivolumab + Chemotherapy15.44Not reported11.9319.52Not reported
Arm C: Chemotherapy9.07Not reported7.699.95Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.6
    ci Upper Limit
    0.90
    estimate Comment
    Stratified Cox proportional hazard model.
    group Description
    Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0010
    p Value Comment
    Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.84
    estimate Comment
    Stratified Cox proportional hazard model
    group Description
    Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0010
    p Value Comment
    Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.5
    ci Upper Limit
    0.80
    estimate Comment
    Stratified Cox proportional hazard model
    group Description
    Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.71
    estimate Comment
    Stratified Cox proportional hazard model
    group Description
    Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.6
    ci Upper Limit
    0.90
    estimate Comment
    Stratified Cox proportional hazard model.
    group Description
    Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0010
    p Value Comment
    Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.84
    estimate Comment
    Stratified Cox proportional hazard model
    group Description
    Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0010
    p Value Comment
    Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.5
    ci Upper Limit
    0.80
    estimate Comment
    Stratified Cox proportional hazard model
    group Description
    Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.71
    estimate Comment
    Stratified Cox proportional hazard model
    group Description
    Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.24
        upper Limit
        17.02
        value
        13.70
      2. group Id
        OG001
        lower Limit
        11.93
        upper Limit
        19.52
        value
        15.44
      3. group Id
        OG002
        lower Limit
        7.69
        upper Limit
        9.95
        value
        9.07
denoms
  1. counts
    1. group Id
      OG000
      value
      158
    2. group Id
      OG001
      value
      158
    3. group Id
      OG002
      value
      157
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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 PD-L1 expressing participants
reporting Status
POSTED
time Frame
From the date of randomization to up to the date of death (up to approximately 20 months)
title
Overall Survival (OS) in Participants With Tumor Cell PD-L1
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice