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NCT02500797 · FLOW

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Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery · Source last updated 2023-10-17

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

groups
  1. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress on single agent nivolumab may elect to cross over to Initial Cohort - Arm II.
    id
    FG000
    title
    Initial Cohort - Arm I (Nivolumab)
  2. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Initial Cohort - Arm II (Nivolumab, Ipilimumab)
  3. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to LPS Cohort - Arm II.
    id
    FG002
    title
    Expansion LPS Cohort - Arm I (Nivolumab)
  4. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    FG003
    title
    Expansion LPS Cohort - Arm II (Nivolumab, Ipilimumab)
  5. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to UPS/MFH Cohort - Arm II.
    id
    FG004
    title
    Expansion UPS/MFH Cohort - Arm I (Nivolumab)
  6. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    FG005
    title
    Expansion UPS/MFH Cohort - Arm II (Nivolumab, Ipilimumab)
  7. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to GIST Cohort - Arm II.
    id
    FG006
    title
    Expansion GIST Cohort - Arm I (Nivolumab)
  8. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    FG007
    title
    Expansion GIST Cohort - Arm II (Nivolumab, Ipilimumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Cancel (rapid disease progression)
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      comment
      Arm I Patients who progress after 10 weeks on single agent nivolumab and cross over to Arm II.
      type
      Arm I Crossover
    3. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        13
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        11
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
GIST Cohort: 24 patients assessed for eligibility; 3 excluded (i.e. ineligible) and 21 randomized.\> LPS Cohort: 37 patients assessed for eligibility; 11 excluded, 3 included (2 pre-registered as UPS/MFH cohort, 1 pre-registered as GIST cohort) and 29 randomized.\> UPS/MFH Cohort: 47 patients assessed for eligibility; 18 excluded and 29 randomized.
Complete source fields
groups
  1. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress on single agent nivolumab may elect to cross over to Initial Cohort - Arm II.
    id
    FG000
    title
    Initial Cohort - Arm I (Nivolumab)
  2. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Initial Cohort - Arm II (Nivolumab, Ipilimumab)
  3. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to LPS Cohort - Arm II.
    id
    FG002
    title
    Expansion LPS Cohort - Arm I (Nivolumab)
  4. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    FG003
    title
    Expansion LPS Cohort - Arm II (Nivolumab, Ipilimumab)
  5. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to UPS/MFH Cohort - Arm II.
    id
    FG004
    title
    Expansion UPS/MFH Cohort - Arm I (Nivolumab)
  6. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    FG005
    title
    Expansion UPS/MFH Cohort - Arm II (Nivolumab, Ipilimumab)
  7. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to GIST Cohort - Arm II.
    id
    FG006
    title
    Expansion GIST Cohort - Arm I (Nivolumab)
  8. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    FG007
    title
    Expansion GIST Cohort - Arm II (Nivolumab, Ipilimumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Cancel (rapid disease progression)
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      comment
      Arm I Patients who progress after 10 weeks on single agent nivolumab and cross over to Arm II.
      type
      Arm I Crossover
    3. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        13
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        11
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
GIST Cohort: 24 patients assessed for eligibility; 3 excluded (i.e. ineligible) and 21 randomized.\> LPS Cohort: 37 patients assessed for eligibility; 11 excluded, 3 included (2 pre-registered as UPS/MFH cohort, 1 pre-registered as GIST cohort) and 29 randomized.\> UPS/MFH Cohort: 47 patients assessed for eligibility; 18 excluded and 29 randomized.

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

Preserved source evidence · Not medical advice