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NCT02452424 · FLOW

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A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors · Source last updated 2020-03-05

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

groups
  1. description
    Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
    id
    FG000
    title
    Dose Escalation: 400 mg/Day
  2. description
    Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG001
    title
    Dose Escalation: 600 mg/Day
  3. description
    Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG002
    title
    Dose Escalation: 600 mg/Day (Liver Metastases
  4. description
    Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG003
    title
    Dose Escalation: 600 mg/Day (no Liver Metastases)
  5. description
    Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
    id
    FG004
    title
    Dose Escalation: 800 mg/Day (Liver Metastases)
  6. description
    Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
    id
    FG005
    title
    Dose Escalation: 800 mg/Day (no Liver Metastases)
  7. description
    Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG006
    title
    Dose Expansion: Melanoma
  8. description
    Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG007
    title
    Dose Expansion: NSCLC
  9. description
    Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG008
    title
    Dose Expansion: Ovarian Cancer
  10. description
    Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG009
    title
    Dose Expansion: SCCHN
  11. description
    Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG010
    title
    Dose Expansion: GIST
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      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
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Other
    5. 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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Progressive disease (per RECIST)
    6. 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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        13
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        15
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Dose Escalation: Up to 42 participants with advanced solid tumors (any type) were to be enrolled sequentially in up to 7 cohorts (3+3 design). Dose Expansion: Up to 483 participants were planned with the sample size for each tumor type based on a truncated sequential probability ratio test (max sample size 28 to 48 participants per tumor type).
recruitment Details
Dose Escalation: 33 participants who met the inclusion and none of the exclusion criteria were enrolled and received study drug. Dose Expansion: 45 participants with melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, squamous cell carcinoma of the head and neck (SCCHN), and gastrointestinal stromal tumor (GIST) were enrolled.
Complete source fields
groups
  1. description
    Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
    id
    FG000
    title
    Dose Escalation: 400 mg/Day
  2. description
    Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG001
    title
    Dose Escalation: 600 mg/Day
  3. description
    Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG002
    title
    Dose Escalation: 600 mg/Day (Liver Metastases
  4. description
    Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG003
    title
    Dose Escalation: 600 mg/Day (no Liver Metastases)
  5. description
    Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
    id
    FG004
    title
    Dose Escalation: 800 mg/Day (Liver Metastases)
  6. description
    Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
    id
    FG005
    title
    Dose Escalation: 800 mg/Day (no Liver Metastases)
  7. description
    Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG006
    title
    Dose Expansion: Melanoma
  8. description
    Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG007
    title
    Dose Expansion: NSCLC
  9. description
    Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG008
    title
    Dose Expansion: Ovarian Cancer
  10. description
    Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG009
    title
    Dose Expansion: SCCHN
  11. description
    Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
    id
    FG010
    title
    Dose Expansion: GIST
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      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
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Other
    5. 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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Progressive disease (per RECIST)
    6. 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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        13
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        15
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Dose Escalation: Up to 42 participants with advanced solid tumors (any type) were to be enrolled sequentially in up to 7 cohorts (3+3 design). Dose Expansion: Up to 483 participants were planned with the sample size for each tumor type based on a truncated sequential probability ratio test (max sample size 28 to 48 participants per tumor type).
recruitment Details
Dose Escalation: 33 participants who met the inclusion and none of the exclusion criteria were enrolled and received study drug. Dose Expansion: 45 participants with melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, squamous cell carcinoma of the head and neck (SCCHN), and gastrointestinal stromal tumor (GIST) were enrolled.

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