Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01213472 · OUTCOME

Humoral Response for Anti NY-ESO-1 Antibodies

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)

What was measured

Anti NY-ESO-1 antibody response was defined as: For initially seronegative patients: post-vaccination antibody concentration greater than or equal to (≥) 179 EU/mL and for intially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.

Analysis population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Groups in this outcome

NY-ESO 1 Group

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group26

Reported measurements

W4

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group24Not reportedNot reportedNot reportedNot reported
W8

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group21Not reportedNot reportedNot reportedNot reported
W10

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group23Not reportedNot reportedNot reportedNot reported
W12

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group19
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group19Not reportedNot reportedNot reportedNot reported
W29

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group13
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group13Not reportedNot reportedNot reportedNot reported
W51

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group6Not reportedNot reportedNot reportedNot reported
W75

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group3Not reportedNot reportedNot reportedNot reported
W99

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group1Not reportedNot reportedNot reportedNot reported
W123

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group0Not reportedNot reportedNot reportedNot reported
POST

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    W4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      units
      Participants
    title
    W8
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    W10
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      units
      Participants
    title
    W12
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    W29
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    W51
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    W75
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    W99
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    W123
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    POST
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Anti NY-ESO-1 antibody response was defined as: For initially seronegative patients: post-vaccination antibody concentration greater than or equal to (≥) 179 EU/mL and for intially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.
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
    OG000
    title
    NY-ESO 1 Group
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.
reporting Status
POSTED
time Frame
At 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)
title
Humoral Response for Anti NY-ESO-1 Antibodies
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice