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NCT03143153 · OUTCOME

Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR

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 the first documented disease progression or death (up to approximately 88 months)

What was measured

Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.

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

GroupSource count
Arm A: Nivolumab + Ipilimumab325
Arm B: Nivolumab + Chemotherapy321
Arm C: Chemotherapy324

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab2.891Not reported2.6614.172Not reported
Arm B: Nivolumab + Chemotherapy5.782Not reported5.5206.998Not reported
Arm C: Chemotherapy5.618Not reported4.3045.914Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.50
    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
    param Type
    Hazard Ratio (HR)
    param Value
    1.25
  2. ci Lower Limit
    0.68
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.00
    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
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
Complete source fields
analyses
  1. ci Lower Limit
    1.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.50
    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
    param Type
    Hazard Ratio (HR)
    param Value
    1.25
  2. ci Lower Limit
    0.68
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.00
    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
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.661
        upper Limit
        4.172
        value
        2.891
      2. group Id
        OG001
        lower Limit
        5.520
        upper Limit
        6.998
        value
        5.782
      3. group Id
        OG002
        lower Limit
        4.304
        upper Limit
        5.914
        value
        5.618
denoms
  1. counts
    1. group Id
      OG000
      value
      325
    2. group Id
      OG001
      value
      321
    3. group Id
      OG002
      value
      324
    units
    Participants
description
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
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 participants
reporting Status
POSTED
time Frame
From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 88 months)
title
Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice