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NCT02741570 · FLOW

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Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-09-21

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

groups
  1. description
    Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
    id
    FG000
    title
    Nivolumab + Ipilimumab
  2. description
    Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
    id
    FG001
    title
    EXTREME Regimen
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      type
      Participant no longer meets study criteria
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Poor/non-compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        18
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant request to discontinue study treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse event unrelated to study drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        472
      2. group Id
        FG001
        num Subjects
        475
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        468
      2. group Id
        FG001
        num Subjects
        441
      comment
      Continuing into treatment period
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Pre-Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        12
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Poor/non-compliance
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      type
      Maximum clinical benefit
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        13
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        23
      type
      Participant request to discontinue treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        26
      type
      Adverse event unrelated to study drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        7
      type
      Death
    9. reasons
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        47
      type
      Study drug toxicity
    10. reasons
      1. group Id
        FG000
        num Subjects
        294
      2. group Id
        FG001
        num Subjects
        301
      type
      Disease progression
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative reason by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        468
      2. group Id
        FG001
        num Subjects
        441
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Participants continuing in the treatment period
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        468
      2. group Id
        FG001
        num Subjects
        441
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
947 participants randomized to receive study treatment. 909 participants received study treatment.
Complete source fields
groups
  1. description
    Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
    id
    FG000
    title
    Nivolumab + Ipilimumab
  2. description
    Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
    id
    FG001
    title
    EXTREME Regimen
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      type
      Participant no longer meets study criteria
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Poor/non-compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        18
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant request to discontinue study treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse event unrelated to study drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        472
      2. group Id
        FG001
        num Subjects
        475
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        468
      2. group Id
        FG001
        num Subjects
        441
      comment
      Continuing into treatment period
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Pre-Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        12
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Poor/non-compliance
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      type
      Maximum clinical benefit
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        13
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        23
      type
      Participant request to discontinue treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        26
      type
      Adverse event unrelated to study drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        7
      type
      Death
    9. reasons
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        47
      type
      Study drug toxicity
    10. reasons
      1. group Id
        FG000
        num Subjects
        294
      2. group Id
        FG001
        num Subjects
        301
      type
      Disease progression
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative reason by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        468
      2. group Id
        FG001
        num Subjects
        441
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Participants continuing in the treatment period
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        468
      2. group Id
        FG001
        num Subjects
        441
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
947 participants randomized to receive study treatment. 909 participants received study treatment.

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

Preserved source evidence · Not medical advice