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NCT02360579 · OUTCOME

Disease Assessment for Disease Control Rate

Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma · Source last updated 2026-03-25

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
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months

What was measured

Evaluate the efficacy endpoints of disease control rate (DCR) by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1

Analysis population: The Full Analysis Set is defined as patients who received the lifileucel infusion that met product manufacturing specifications. Due to the small number of patients this outcome measure was not analyzed for Cohort 3 per the statistical analysis plan.

Groups in this outcome

Cohort 2

Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)

Cohort 4

Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)

Cohort 1

Non-cryopreserved LN-144 (Gen 1 infusion product)

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

Analysis denominator · Participants

GroupSource count
Cohort 266
Cohort 487
Cohort 120

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 248Not reportedNot reportedNot reportedNot reported
Cohort 472Not reportedNot reportedNot reportedNot reported
Cohort 112Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        72
      3. group Id
        OG002
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      87
    3. group Id
      OG002
      value
      20
    units
    Participants
description
Evaluate the efficacy endpoints of disease control rate (DCR) by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1
groups
  1. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
    id
    OG000
    title
    Cohort 2
  2. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
    id
    OG001
    title
    Cohort 4
  3. description
    Non-cryopreserved LN-144 (Gen 1 infusion product)
    id
    OG002
    title
    Cohort 1
param Type
COUNT_OF_PARTICIPANTS
population Description
The Full Analysis Set is defined as patients who received the lifileucel infusion that met product manufacturing specifications. Due to the small number of patients this outcome measure was not analyzed for Cohort 3 per the statistical analysis plan.
reporting Status
POSTED
time Frame
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
title
Disease Assessment for Disease Control Rate
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice