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NCT02526017 · FLOW

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Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers · Source last updated 2022-03-09

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

groups
  1. description
    Participants received 2 mg/kg cabiralizumab administered intravenously (IV) once every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG000
    title
    Phase 1a: Cabiralizumab 2 mg/kg Q2W
  2. description
    Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG001
    title
    Phase 1a: Cabiralizumab 4 mg/kg Q2W
  3. description
    Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG002
    title
    Phase 1a: Cabiralizumab 6 mg/kg Q2W
  4. description
    Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG003
    title
    Phase 1a: Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W
  5. description
    Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG004
    title
    Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W
  6. description
    Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG005
    title
    Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
  7. description
    Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG006
    title
    Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W
  8. description
    Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG007
    title
    Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W
  9. description
    Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG008
    title
    Phase 1b: Cabiralizumab 4 mg/kg + Nivolumab 3 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
        1
      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
      type
      Withdrew Consent Before Receiving Study Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        262
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        262
      type
      Received Study Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        262
      type
      COMPLETED
    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
        1
      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
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The primary objective of the study was to assess the safety and tolerability of cabiralizumab alone and in combination with nivolumab. Accordingly, the safety results are grouped by patients who received the same dose and schedule of both medications. The co-primary objective for the Phase 1b portion was to evaluate the clinical benefit. Accordingly, the efficacy results from Phase 1b are reported by tumor types.
recruitment Details
This study included a Phase 1a dose escalation and a Phase 1b dose expansion. The dose escalation phase consisted of cabiralizumab monotherapy cohorts and cohorts of cabiralizumab in combination with nivolumab. All dose escalation decisions were based on assessment of dose-limiting toxicity (DLT), overall safety, and tolerability. Enrollment in Phase 1b expansion began after a recommended dose had been identified in Phase 1a.
Complete source fields
groups
  1. description
    Participants received 2 mg/kg cabiralizumab administered intravenously (IV) once every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG000
    title
    Phase 1a: Cabiralizumab 2 mg/kg Q2W
  2. description
    Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG001
    title
    Phase 1a: Cabiralizumab 4 mg/kg Q2W
  3. description
    Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG002
    title
    Phase 1a: Cabiralizumab 6 mg/kg Q2W
  4. description
    Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG003
    title
    Phase 1a: Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W
  5. description
    Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG004
    title
    Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W
  6. description
    Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG005
    title
    Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
  7. description
    Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG006
    title
    Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W
  8. description
    Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG007
    title
    Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W
  9. description
    Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    FG008
    title
    Phase 1b: Cabiralizumab 4 mg/kg + Nivolumab 3 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
        1
      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
      type
      Withdrew Consent Before Receiving Study Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        262
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        262
      type
      Received Study Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        262
      type
      COMPLETED
    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
        1
      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
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The primary objective of the study was to assess the safety and tolerability of cabiralizumab alone and in combination with nivolumab. Accordingly, the safety results are grouped by patients who received the same dose and schedule of both medications. The co-primary objective for the Phase 1b portion was to evaluate the clinical benefit. Accordingly, the efficacy results from Phase 1b are reported by tumor types.
recruitment Details
This study included a Phase 1a dose escalation and a Phase 1b dose expansion. The dose escalation phase consisted of cabiralizumab monotherapy cohorts and cohorts of cabiralizumab in combination with nivolumab. All dose escalation decisions were based on assessment of dose-limiting toxicity (DLT), overall safety, and tolerability. Enrollment in Phase 1b expansion began after a recommended dose had been identified in Phase 1a.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice