Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01213472 · OUTCOME

Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria

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

Patients with Slow Progressive Disease (SPD) status met the following criteria: patient's Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1, patient's lactate dehydrogenase (LDH) value was not greater than twice the normal upper limit, there was no appearance of visceral metastases other than in the lung, patients did not meet any of the criteria for permanent stopping of study treatment. Mixed response (MxR) criteria was defined as follows: at least 30% decrease in the longest diameter (LD) occurring in at least one target lesion recorded and measured at baseline. Such response occurring in otherwise stable disease (SD) or progressive disease (PD) status of LD of target lesions and without the appearance of one or more new lesions were classified as "SD with target lesion regression" or "PD with target lesion regression". The appearance of new lesions in otherwise partial response (PR) status of the LD of target lesions were classified as "PR with new lesion".

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

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group3Not reportedNot reportedNot reportedNot reported
PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group2Not reportedNot reportedNot reportedNot reported
SD/PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group2Not reportedNot reportedNot reportedNot reported
MxR: SD with target lesion regression
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group0Not reportedNot reportedNot reportedNot reported
MxR: PD with target lesion regression
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group3Not reportedNot reportedNot reportedNot reported
MxR: PR with new lesion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group2Not reportedNot reportedNot reportedNot reported
SD without mixed response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group2Not reportedNot reportedNot reportedNot reported
PD with SPD criteria
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group10Not reportedNot reportedNot reportedNot reported
PD without SPD/MxR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group8Not reportedNot reportedNot reportedNot reported
NE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    PR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    SD/PR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    MxR: SD with target lesion regression
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    MxR: PD with target lesion regression
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    MxR: PR with new lesion
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    SD without mixed response
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    PD with SPD criteria
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    PD without SPD/MxR
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    NE
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Patients with Slow Progressive Disease (SPD) status met the following criteria: patient's Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1, patient's lactate dehydrogenase (LDH) value was not greater than twice the normal upper limit, there was no appearance of visceral metastases other than in the lung, patients did not meet any of the criteria for permanent stopping of study treatment. Mixed response (MxR) criteria was defined as follows: at least 30% decrease in the longest diameter (LD) occurring in at least one target lesion recorded and measured at baseline. Such response occurring in otherwise stable disease (SD) or progressive disease (PD) status of LD of target lesions and without the appearance of one or more new lesions were classified as "SD with target lesion regression" or "PD with target lesion regression". The appearance of new lesions in otherwise partial response (PR) status of the LD of target lesions were classified as "PR with new lesion".
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 Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice