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NCT02872116 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    title
    Arm 3: Nivolumab + Ipilimumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse event unrelated to study drug
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Participants request to discontinue study treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        3
      type
      Participant withdrew consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Participant no longer meets study criteria
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        789
      2. group Id
        FG001
        num Subjects
        833
      3. group Id
        FG002
        num Subjects
        409
      comment
      = Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        782
      2. group Id
        FG001
        num Subjects
        806
      3. group Id
        FG002
        num Subjects
        403
      comment
      = Moving to treatment period
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        121
      2. group Id
        FG001
        num Subjects
        94
      3. group Id
        FG002
        num Subjects
        68
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        8
      type
      Participant withdrew consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        5
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        782
      2. group Id
        FG001
        num Subjects
        806
      3. group Id
        FG002
        num Subjects
        403
      comment
      Treated
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        623
      2. group Id
        FG001
        num Subjects
        653
      3. group Id
        FG002
        num Subjects
        319
      comment
      Continuing in the study
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        84
      type
      NOT COMPLETED
    title
    Treatment
pre Assignment Details
2031 Participants Randomized and 1991 Treated
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    title
    Arm 3: Nivolumab + Ipilimumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse event unrelated to study drug
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Participants request to discontinue study treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        3
      type
      Participant withdrew consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Participant no longer meets study criteria
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        789
      2. group Id
        FG001
        num Subjects
        833
      3. group Id
        FG002
        num Subjects
        409
      comment
      = Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        782
      2. group Id
        FG001
        num Subjects
        806
      3. group Id
        FG002
        num Subjects
        403
      comment
      = Moving to treatment period
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        121
      2. group Id
        FG001
        num Subjects
        94
      3. group Id
        FG002
        num Subjects
        68
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        8
      type
      Participant withdrew consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        5
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        782
      2. group Id
        FG001
        num Subjects
        806
      3. group Id
        FG002
        num Subjects
        403
      comment
      Treated
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        623
      2. group Id
        FG001
        num Subjects
        653
      3. group Id
        FG002
        num Subjects
        319
      comment
      Continuing in the study
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        84
      type
      NOT COMPLETED
    title
    Treatment
pre Assignment Details
2031 Participants Randomized and 1991 Treated

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Preserved source evidence · Not medical advice