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NCT02360579 · OUTCOME

Disease Assessment for Duration of Response

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
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 duration of response (DOR) 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 223
Cohort 425
Cohort 14

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 2NANot reportedNANAInsufficient number of participants with events, therefore the Median and 95% Confidence Interval were not reached
Cohort 410.4Not reported4.126.2Not reported
Cohort 1NANot reported3.0NAInsufficient number of participants with events, therefore the Median and 95% Confidence Interval were not reached
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events, therefore the Median and 95% Confidence Interval were not reached
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        26.2
        value
        10.4
      3. comment
        Insufficient number of participants with events, therefore the Median and 95% Confidence Interval were not reached
        group Id
        OG002
        lower Limit
        3.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Evaluate the efficacy endpoints of duration of response (DOR) by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1
dispersion Type
95% Confidence Interval
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
MEDIAN
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 Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice