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NCT03143153 · OUTCOME

Progression-free Survival (PFS) as Assessed by BICR 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 the first documented disease progression or death (up to approximately 9 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 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 + Ipilimumab4.04Not reported2.404.93Not reported
Arm B: Nivolumab + Chemotherapy6.93Not reported5.688.34Not reported
Arm C: Chemotherapy4.44Not reported2.895.82Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.5
    ci Upper Limit
    1.43
    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
    0.8958
    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
    1.02
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.34
    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
    0.8958
    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
    1.02
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.5
    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
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0023
    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
    0.65
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.86
    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
    0.0023
    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
    0.65
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.5
    ci Upper Limit
    1.43
    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
    0.8958
    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
    1.02
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.34
    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
    0.8958
    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
    1.02
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.5
    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
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0023
    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
    0.65
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.86
    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
    0.0023
    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
    0.65
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.40
        upper Limit
        4.93
        value
        4.04
      2. group Id
        OG001
        lower Limit
        5.68
        upper Limit
        8.34
        value
        6.93
      3. group Id
        OG002
        lower Limit
        2.89
        upper Limit
        5.82
        value
        4.44
denoms
  1. counts
    1. group Id
      OG000
      value
      158
    2. group Id
      OG001
      value
      158
    3. group Id
      OG002
      value
      157
    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 PD-L1 expressing 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 9 months)
title
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1
type
PRIMARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice