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NCT01213472 · OUTCOME

Number of Patients With the Best Overall Response in the Overall Population

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
During the study treatment period (maximum duration = 49 months).

What was measured

Best response was recorded from the start of treatment until disease progression. Response assessment was essentially based on a set of measurable lesions (target lesions \[TL\]), and any other lesions (non-target lesions \[NTL\]), both identified at baseline. Complete Response (CR)=disappearance of all TL or NTL; Partial Response (PR) = at least 30 percent (%) decrease in the sum of the longest diameter(LD) of TL compared to baseline, stable disease (SD) = neither sufficient shrinkage to qualify PR nor sufficient increase to qualify for Progressive disease (PD) compared with baseline; PD = at least 20% increase in the sum of LD of TL compared with baseline, or the appearance of one or more new lesions, or both of these, and/or unequivocal progression of existing NTL; NE =non-evaluable; Clinical response: any CR or PR best overall response; Disease control: any CR, PR, SD or SD/PR best overall response.

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 Group33

Reported measurements

Best response, CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group3Not reportedNot reportedNot reportedNot reported
Best response, PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group2Not reportedNot reportedNot reportedNot reported
Best response, SD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group2Not reportedNot reportedNot reportedNot reported
Best response, SD/PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group2Not reportedNot reportedNot reportedNot reported
Best response, PD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group23Not reportedNot reportedNot reportedNot reported
Best response, NE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group1Not reportedNot reportedNot reportedNot reported
Clinical Response, Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group5Not reportedNot reportedNot reportedNot reported
Clinical Response, No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group28Not reportedNot reportedNot reportedNot reported
Disease control, Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group9Not reportedNot reportedNot reportedNot reported
Disease control, No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Best response, CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Best response, PR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Best response, SD
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Best response, SD/PR
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    Best response, PD
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Best response, NE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Clinical Response, Yes
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        28
    title
    Clinical Response, No
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Disease control, Yes
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    Disease control, No
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Best response was recorded from the start of treatment until disease progression. Response assessment was essentially based on a set of measurable lesions (target lesions \[TL\]), and any other lesions (non-target lesions \[NTL\]), both identified at baseline. Complete Response (CR)=disappearance of all TL or NTL; Partial Response (PR) = at least 30 percent (%) decrease in the sum of the longest diameter(LD) of TL compared to baseline, stable disease (SD) = neither sufficient shrinkage to qualify PR nor sufficient increase to qualify for Progressive disease (PD) compared with baseline; PD = at least 20% increase in the sum of LD of TL compared with baseline, or the appearance of one or more new lesions, or both of these, and/or unequivocal progression of existing NTL; NE =non-evaluable; Clinical response: any CR or PR best overall response; Disease control: any CR, PR, SD or SD/PR best overall response.
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
During the study treatment period (maximum duration = 49 months).
title
Number of Patients With the Best Overall Response in the Overall Population
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice