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NCT02872116 · BASELINE

Baseline characteristics

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer · Source last updated 2025-08-07

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

denoms
  1. counts
    1. group Id
      BG000
      value
      789
    2. group Id
      BG001
      value
      833
    3. group Id
      BG002
      value
      409
    4. group Id
      BG003
      value
      2031
    units
    Participants
groups
  1. description
    Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
    id
    BG000
    title
    Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
  2. description
    Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
    id
    BG001
    title
    Arm 2: Chemotherapy (XELOX or FOLFOX)
  3. description
    1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
    id
    BG002
    title
    Arm 3: Nivolumab + Ipilimumab
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.9
          value
          60.3
        2. group Id
          BG001
          spread
          12.1
          value
          59.8
        3. group Id
          BG002
          spread
          11.7
          value
          59.4
        4. group Id
          BG003
          spread
          12.0
          value
          59.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          249
        2. group Id
          BG001
          value
          246
        3. group Id
          BG002
          value
          131
        4. group Id
          BG003
          value
          626
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          540
        2. group Id
          BG001
          value
          587
        3. group Id
          BG002
          value
          278
        4. group Id
          BG003
          value
          1405
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          26
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          124
        4. group Id
          BG003
          value
          510
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          24
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          556
        2. group Id
          BG001
          value
          570
        3. group Id
          BG002
          value
          264
        4. group Id
          BG003
          value
          1390
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          81
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      789
    2. group Id
      BG001
      value
      833
    3. group Id
      BG002
      value
      409
    4. group Id
      BG003
      value
      2031
    units
    Participants
groups
  1. description
    Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
    id
    BG000
    title
    Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
  2. description
    Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
    id
    BG001
    title
    Arm 2: Chemotherapy (XELOX or FOLFOX)
  3. description
    1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
    id
    BG002
    title
    Arm 3: Nivolumab + Ipilimumab
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.9
          value
          60.3
        2. group Id
          BG001
          spread
          12.1
          value
          59.8
        3. group Id
          BG002
          spread
          11.7
          value
          59.4
        4. group Id
          BG003
          spread
          12.0
          value
          59.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          249
        2. group Id
          BG001
          value
          246
        3. group Id
          BG002
          value
          131
        4. group Id
          BG003
          value
          626
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          540
        2. group Id
          BG001
          value
          587
        3. group Id
          BG002
          value
          278
        4. group Id
          BG003
          value
          1405
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          26
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          124
        4. group Id
          BG003
          value
          510
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          24
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          556
        2. group Id
          BG001
          value
          570
        3. group Id
          BG002
          value
          264
        4. group Id
          BG003
          value
          1390
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          81
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice