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NCT01213472 · FLOW

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Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma · Source last updated 2019-10-09

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

groups
  1. description
    Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
    id
    FG000
    title
    NY-ESO 1 Group
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Recurrence/Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Accordingly, patients still on treatment in the study, at the time of protocol amendment 3, either continued until last dose or until recurrence, whichever came first, or until patient or investigator decided to stop study treatment. Therefore, the results summary contain limited primary and secondary endpoints results, and are merely descriptive.
recruitment Details
Among 169 subjects screened, 33 were vaccinated and 6 completed the study. Following the NCT00480025 and NCT00796445 studies, which failed to demonstrate clinical efficacy of the MAGE-A3 antigen-specific cancer immunotherapeutic (ASCI), GSK decided to stop the development of ASCI studies and recruitment in ongoing studies.
Complete source fields
groups
  1. description
    Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
    id
    FG000
    title
    NY-ESO 1 Group
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Recurrence/Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Accordingly, patients still on treatment in the study, at the time of protocol amendment 3, either continued until last dose or until recurrence, whichever came first, or until patient or investigator decided to stop study treatment. Therefore, the results summary contain limited primary and secondary endpoints results, and are merely descriptive.
recruitment Details
Among 169 subjects screened, 33 were vaccinated and 6 completed the study. Following the NCT00480025 and NCT00796445 studies, which failed to demonstrate clinical efficacy of the MAGE-A3 antigen-specific cancer immunotherapeutic (ASCI), GSK decided to stop the development of ASCI studies and recruitment in ongoing studies.

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

Preserved source evidence · Not medical advice