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NCT00769704 · FLOW

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Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma · Source last updated 2016-07-13

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

groups
  1. description
    Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    id
    FG000
    title
    GM-CSF
  2. description
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    id
    FG001
    title
    Talimogene Laherparepvec
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        95
      2. group Id
        FG001
        num Subjects
        190
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        141
      2. group Id
        FG001
        num Subjects
        296
      type
      STARTED
    2. achievements
      1. comment
        All participants who were randomized once to study treatment
        group Id
        FG000
        num Subjects
        141
      2. comment
        Participants who were randomized once to study treatment; excludes 1 participant randomized 3 times
        group Id
        FG001
        num Subjects
        295
      type
      Intent-to-treat Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        292
      type
      Received Treatment
    4. achievements
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        97
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        111
      2. group Id
        FG001
        num Subjects
        199
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients were assigned at a 2:1 ratio using central random assignment to receive intralesional talimogene laherparepvec or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). Randomization was stratified by site of first recurrence, presence of liver metastases, disease stage, and prior nonadjuvant systemic treatment.
recruitment Details
Eligible patients were adults with histologically confirmed, not surgically resectable, stage IIIB - IV melanoma suitable for direct or ultrasound-guided injection. Among those randomized, the first patient enrolled 29 April 2009 and last patient enrolled 8 June 2011. 1 patient randomized 3 times is counted once under talimogene laherparepvec.
Complete source fields
groups
  1. description
    Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    id
    FG000
    title
    GM-CSF
  2. description
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    id
    FG001
    title
    Talimogene Laherparepvec
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        95
      2. group Id
        FG001
        num Subjects
        190
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        141
      2. group Id
        FG001
        num Subjects
        296
      type
      STARTED
    2. achievements
      1. comment
        All participants who were randomized once to study treatment
        group Id
        FG000
        num Subjects
        141
      2. comment
        Participants who were randomized once to study treatment; excludes 1 participant randomized 3 times
        group Id
        FG001
        num Subjects
        295
      type
      Intent-to-treat Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        292
      type
      Received Treatment
    4. achievements
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        97
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        111
      2. group Id
        FG001
        num Subjects
        199
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients were assigned at a 2:1 ratio using central random assignment to receive intralesional talimogene laherparepvec or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). Randomization was stratified by site of first recurrence, presence of liver metastases, disease stage, and prior nonadjuvant systemic treatment.
recruitment Details
Eligible patients were adults with histologically confirmed, not surgically resectable, stage IIIB - IV melanoma suitable for direct or ultrasound-guided injection. Among those randomized, the first patient enrolled 29 April 2009 and last patient enrolled 8 June 2011. 1 patient randomized 3 times is counted once under talimogene laherparepvec.

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Preserved source evidence · Not medical advice