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NCT03143153 · OUTCOME

Objective Response Rate (ORR) 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 88 months)

What was measured

Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.

Analysis population: All randomized PD-L1 expressing participants and 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

Participants with baseline PD-L1 status < 1%

Analysis denominator · Participants

GroupSource count
Arm A: Nivolumab + Ipilimumab164
Arm B: Nivolumab + Chemotherapy163
Arm C: Chemotherapy166
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab20.1Not reported14.327.1Not reported
Arm B: Nivolumab + Chemotherapy41.7Not reported34.149.7Not reported
Arm C: Chemotherapy33.7Not reported26.641.5Not reported
Participants with baseline PD-L1 status >= 1%

Analysis denominator · Participants

GroupSource count
Arm A: Nivolumab + Ipilimumab158
Arm B: Nivolumab + Chemotherapy158
Arm C: Chemotherapy156
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab35.4Not reported28.043.4Not reported
Arm B: Nivolumab + Chemotherapy53.2Not reported45.161.1Not reported
Arm C: Chemotherapy19.9Not reported13.927.0Not reported
Participants with baseline PD-L1 status < 5%

Analysis denominator · Participants

GroupSource count
Arm A: Nivolumab + Ipilimumab202
Arm B: Nivolumab + Chemotherapy201
Arm C: Chemotherapy207
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab22.3Not reported16.728.6Not reported
Arm B: Nivolumab + Chemotherapy44.8Not reported37.851.9Not reported
Arm C: Chemotherapy30.9Not reported24.737.7Not reported
Participants with baseline PD-L1 status >= 5%

Analysis denominator · Participants

GroupSource count
Arm A: Nivolumab + Ipilimumab120
Arm B: Nivolumab + Chemotherapy120
Arm C: Chemotherapy115
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab36.7Not reported28.145.9Not reported
Arm B: Nivolumab + Chemotherapy51.7Not reported42.460.9Not reported
Arm C: Chemotherapy20.0Not reported13.128.5Not reported
Participants with baseline PD-L1 status < 10%

Analysis denominator · Participants

GroupSource count
Arm A: Nivolumab + Ipilimumab219
Arm B: Nivolumab + Chemotherapy219
Arm C: Chemotherapy225
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab23.3Not reported17.929.5Not reported
Arm B: Nivolumab + Chemotherapy46.1Not reported39.453.0Not reported
Arm C: Chemotherapy29.3Not reported23.535.8Not reported
Participants with baseline PD-L1 status >= 10%

Analysis denominator · Participants

GroupSource count
Arm A: Nivolumab + Ipilimumab103
Arm B: Nivolumab + Chemotherapy102
Arm C: Chemotherapy97
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab36.9Not reported27.647.0Not reported
Arm B: Nivolumab + Chemotherapy50.0Not reported39.960.1Not reported
Arm C: Chemotherapy21.6Not reported13.931.2Not reported
Participants with baseline PD-L1 status indeterminate, not evaluable, or missing

Analysis denominator · Participants

GroupSource count
Arm A: Nivolumab + Ipilimumab3
Arm B: Nivolumab + Chemotherapy0
Arm C: Chemotherapy2
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab33.3Not reported0.890.6Not reported
Arm C: Chemotherapy0.0Not reported0.084.2Not reported
All randomized participants

Analysis denominator · Participants

GroupSource count
Arm A: Nivolumab + Ipilimumab325
Arm B: Nivolumab + Chemotherapy321
Arm C: Chemotherapy324
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Nivolumab + Ipilimumab27.4Not reported22.632.6Not reported
Arm B: Nivolumab + Chemotherapy47.4Not reported41.853.0Not reported
Arm C: Chemotherapy26.9Not reported22.132.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.3
        upper Limit
        27.1
        value
        20.1
      2. group Id
        OG001
        lower Limit
        34.1
        upper Limit
        49.7
        value
        41.7
      3. group Id
        OG002
        lower Limit
        26.6
        upper Limit
        41.5
        value
        33.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        164
      2. group Id
        OG001
        value
        163
      3. group Id
        OG002
        value
        166
      units
      Participants
    title
    Participants with baseline PD-L1 status < 1%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.0
        upper Limit
        43.4
        value
        35.4
      2. group Id
        OG001
        lower Limit
        45.1
        upper Limit
        61.1
        value
        53.2
      3. group Id
        OG002
        lower Limit
        13.9
        upper Limit
        27.0
        value
        19.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        158
      2. group Id
        OG001
        value
        158
      3. group Id
        OG002
        value
        156
      units
      Participants
    title
    Participants with baseline PD-L1 status >= 1%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.7
        upper Limit
        28.6
        value
        22.3
      2. group Id
        OG001
        lower Limit
        37.8
        upper Limit
        51.9
        value
        44.8
      3. group Id
        OG002
        lower Limit
        24.7
        upper Limit
        37.7
        value
        30.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      2. group Id
        OG001
        value
        201
      3. group Id
        OG002
        value
        207
      units
      Participants
    title
    Participants with baseline PD-L1 status < 5%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.1
        upper Limit
        45.9
        value
        36.7
      2. group Id
        OG001
        lower Limit
        42.4
        upper Limit
        60.9
        value
        51.7
      3. group Id
        OG002
        lower Limit
        13.1
        upper Limit
        28.5
        value
        20.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        120
      2. group Id
        OG001
        value
        120
      3. group Id
        OG002
        value
        115
      units
      Participants
    title
    Participants with baseline PD-L1 status >= 5%
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.9
        upper Limit
        29.5
        value
        23.3
      2. group Id
        OG001
        lower Limit
        39.4
        upper Limit
        53.0
        value
        46.1
      3. group Id
        OG002
        lower Limit
        23.5
        upper Limit
        35.8
        value
        29.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        219
      2. group Id
        OG001
        value
        219
      3. group Id
        OG002
        value
        225
      units
      Participants
    title
    Participants with baseline PD-L1 status < 10%
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.6
        upper Limit
        47.0
        value
        36.9
      2. group Id
        OG001
        lower Limit
        39.9
        upper Limit
        60.1
        value
        50.0
      3. group Id
        OG002
        lower Limit
        13.9
        upper Limit
        31.2
        value
        21.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        103
      2. group Id
        OG001
        value
        102
      3. group Id
        OG002
        value
        97
      units
      Participants
    title
    Participants with baseline PD-L1 status >= 10%
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8
        upper Limit
        90.6
        value
        33.3
      2. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        84.2
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Participants with baseline PD-L1 status indeterminate, not evaluable, or missing
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.6
        upper Limit
        32.6
        value
        27.4
      2. group Id
        OG001
        lower Limit
        41.8
        upper Limit
        53.0
        value
        47.4
      3. group Id
        OG002
        lower Limit
        22.1
        upper Limit
        32.0
        value
        26.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        325
      2. group Id
        OG001
        value
        321
      3. group Id
        OG002
        value
        324
      units
      Participants
    title
    All randomized participants
denoms
  1. counts
    1. group Id
      OG000
      value
      325
    2. group Id
      OG001
      value
      321
    3. group Id
      OG002
      value
      324
    units
    Participants
description
Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.
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
NUMBER
population Description
All randomized PD-L1 expressing participants and all randomized participants
reporting Status
POSTED
time Frame
From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 88 months)
title
Objective Response Rate (ORR) as Assessed by BICR
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice