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NCT02460224 · FLOW

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Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. · Source last updated 2022-02-10

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

groups
  1. description
    Single-agent LAG525 1 mg/kg Q2W
    id
    FG000
    title
    Phase 1: LAG525 1 mg/kg Q2W
  2. description
    Single-agent LAG525 3 mg/kg Q2W
    id
    FG001
    title
    Phase 1: LAG525 3 mg/kg Q2W
  3. description
    Single-agent LAG525 5 mg/kg Q2W
    id
    FG002
    title
    Phase 1: LAG525 5 mg/kg Q2W
  4. description
    Single-agent LAG525 10 mg/kg Q2W
    id
    FG003
    title
    Phase 1: LAG525 10 mg/kg Q2W
  5. description
    Single-agent LAG525 15 mg/kg Q2W
    id
    FG004
    title
    Phase 1: LAG525 15 mg/kg Q2W
  6. description
    Single-agent LAG525 240 mg Q2W
    id
    FG005
    title
    Phase 1: LAG525 240 mg Q2W
  7. description
    Single-agent LAG525 400 mg Q2W
    id
    FG006
    title
    Phase 1: LAG525 400 mg Q2W
  8. description
    Single-agent LAG525 3 mg/kg Q4W
    id
    FG007
    title
    Phase 1: LAG525 3 mg/kg Q4W
  9. description
    Single-agent LAG525 5 mg/kg Q4W
    id
    FG008
    title
    Phase 1: LAG525 5 mg/kg Q4W
  10. description
    Single-agent LAG525 10 mg/kg Q4W
    id
    FG009
    title
    Phase 1: LAG525 10 mg/kg Q4W
  11. description
    Single-agent LAG525 400 mg Q4W
    id
    FG010
    title
    Phase 1: LAG525 400 mg Q4W
  12. description
    Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
    id
    FG011
    title
    Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
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
        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
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Adverse Event
    2. 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
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Death
    3. 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
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        26
      7. group Id
        FG006
        num Subjects
        28
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        9
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        4
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      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
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      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
      12. group Id
        FG011
        num Subjects
        1
      type
      Subject/guardian decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        30
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        25
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        6
      type
      Rest of the World Patients in the Dose Escalation Part
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      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
        5
      7. group Id
        FG006
        num Subjects
        6
      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
      12. group Id
        FG011
        num Subjects
        0
      type
      Japanese Patients in the Dose Escalation Part
    4. achievements
      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
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        30
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The screening period began once patients had signed the study informed consent. All screening/baseline evaluations were performed ≤ 21 days before Cycle 1 Day 1, except for baseline radiological evaluations which had to be done within 28 days.
recruitment Details
Participants took part in 25 investigative sites in 12 countries.
Complete source fields
groups
  1. description
    Single-agent LAG525 1 mg/kg Q2W
    id
    FG000
    title
    Phase 1: LAG525 1 mg/kg Q2W
  2. description
    Single-agent LAG525 3 mg/kg Q2W
    id
    FG001
    title
    Phase 1: LAG525 3 mg/kg Q2W
  3. description
    Single-agent LAG525 5 mg/kg Q2W
    id
    FG002
    title
    Phase 1: LAG525 5 mg/kg Q2W
  4. description
    Single-agent LAG525 10 mg/kg Q2W
    id
    FG003
    title
    Phase 1: LAG525 10 mg/kg Q2W
  5. description
    Single-agent LAG525 15 mg/kg Q2W
    id
    FG004
    title
    Phase 1: LAG525 15 mg/kg Q2W
  6. description
    Single-agent LAG525 240 mg Q2W
    id
    FG005
    title
    Phase 1: LAG525 240 mg Q2W
  7. description
    Single-agent LAG525 400 mg Q2W
    id
    FG006
    title
    Phase 1: LAG525 400 mg Q2W
  8. description
    Single-agent LAG525 3 mg/kg Q4W
    id
    FG007
    title
    Phase 1: LAG525 3 mg/kg Q4W
  9. description
    Single-agent LAG525 5 mg/kg Q4W
    id
    FG008
    title
    Phase 1: LAG525 5 mg/kg Q4W
  10. description
    Single-agent LAG525 10 mg/kg Q4W
    id
    FG009
    title
    Phase 1: LAG525 10 mg/kg Q4W
  11. description
    Single-agent LAG525 400 mg Q4W
    id
    FG010
    title
    Phase 1: LAG525 400 mg Q4W
  12. description
    Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
    id
    FG011
    title
    Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
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
        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
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Adverse Event
    2. 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
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Death
    3. 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
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        26
      7. group Id
        FG006
        num Subjects
        28
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        9
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        4
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      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
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      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
      12. group Id
        FG011
        num Subjects
        1
      type
      Subject/guardian decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        30
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        25
      7. group Id
        FG006
        num Subjects
        24
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        6
      type
      Rest of the World Patients in the Dose Escalation Part
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      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
        5
      7. group Id
        FG006
        num Subjects
        6
      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
      12. group Id
        FG011
        num Subjects
        0
      type
      Japanese Patients in the Dose Escalation Part
    4. achievements
      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
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        30
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        5
      12. group Id
        FG011
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The screening period began once patients had signed the study informed consent. All screening/baseline evaluations were performed ≤ 21 days before Cycle 1 Day 1, except for baseline radiological evaluations which had to be done within 28 days.
recruitment Details
Participants took part in 25 investigative sites in 12 countries.

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