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NCT03141177 · FLOW

Participant flow

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma · Source last updated 2026-08-24

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

groups
  1. description
    Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    FG000
    title
    Treatment A
  2. description
    Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    FG001
    title
    Treatment B
  3. description
    Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
    id
    FG002
    title
    Treatment C
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        84
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        13
      type
      Participant withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Not reported
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      Other reasons
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      type
      Participants did not start treatment period
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        323
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        328
      comment
      Started=Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        320
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        320
      comment
      Treated=Started treatment period
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        210
      comment
      Completed=Continuing in the Study
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        81
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        118
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
701 participants randomized and 690 treated.
Complete source fields
groups
  1. description
    Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    FG000
    title
    Treatment A
  2. description
    Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    FG001
    title
    Treatment B
  3. description
    Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
    id
    FG002
    title
    Treatment C
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        84
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        13
      type
      Participant withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Not reported
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      Other reasons
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      type
      Participants did not start treatment period
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        323
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        328
      comment
      Started=Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        320
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        320
      comment
      Treated=Started treatment period
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        210
      comment
      Completed=Continuing in the Study
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        81
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        118
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
701 participants randomized and 690 treated.

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Preserved source evidence · Not medical advice