Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for Cohorts 1 \& 3 and as assessed by Independent Review Committee (IRC) per RECIST Version 1.1 for Cohorts 2 \& 4

The Full Analysis Set is defined as patients who received the lifileucel infusion that met product manufacturing specifications. Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen.

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secondary · POSTED

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

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.

→

secondary · POSTED

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

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secondary · POSTED

Evaluate the efficacy endpoints of Progression-Free Survival by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1

→

secondary · POSTED

Evaluate overall survival (OS)

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secondary · POSTED

Incidence, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events

The Safety Analysis Set is defined as patients who received the LN-144 infusion. Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-melanoma-keytruda-qlex-b6745983
nct id: NCT02360579
trial label: Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0000
source section id
NCT02360579-om-0000
source outcome index
0
endpoint
Disease Assessment for Objective Response Rate
endpoint definition
Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for Cohorts 1 \& 3 and as assessed by Independent Review Committee (IRC) per RECIST Version 1.1 for Cohorts 2 \& 4
time origin
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The Full Analysis Set is defined as patients who received the lifileucel infusion that met product manufacturing specifications. Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0001
source section id
NCT02360579-om-0001
source outcome index
1
endpoint
Disease Assessment for Duration of Response
endpoint definition
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
time origin
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0002
source section id
NCT02360579-om-0002
source outcome index
2
endpoint
Disease Assessment for Disease Control Rate
endpoint definition
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
time origin
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0003
source section id
NCT02360579-om-0003
source outcome index
3
endpoint
Disease Assessment for Progression-Free Survival
endpoint definition
Evaluate the efficacy endpoints of Progression-Free Survival by the IRC for Cohorts 2 \& 4 and by the investigator for Cohort 1 per RECIST v1.1
time origin
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0004
source section id
NCT02360579-om-0004
source outcome index
4
endpoint
Overall Survival
endpoint definition
Evaluate overall survival (OS)
time origin
Until death or up to 60 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0005
source section id
NCT02360579-om-0005
source outcome index
5
endpoint
Safety Profile
endpoint definition
Incidence, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events
time origin
Maximum 60 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The Safety Analysis Set is defined as patients who received the LN-144 infusion. Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0000
arm key
OG000
arm label
Cohort 1
regimen
Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0000
arm key
OG001
arm label
Cohort 2
regimen
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
analyzed count
66
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0000
arm key
OG002
arm label
Cohort 3
regimen
Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0000
arm key
OG003
arm label
Cohort 4
regimen
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Lifileucel: A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0001
arm key
OG000
arm label
Cohort 2
regimen
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0001
arm key
OG001
arm label
Cohort 4
regimen
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0001
arm key
OG002
arm label
Cohort 1
regimen
Non-cryopreserved LN-144 (Gen 1 infusion product)
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0002
arm key
OG000
arm label
Cohort 2
regimen
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
analyzed count
66
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0002
arm key
OG001
arm label
Cohort 4
regimen
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0002
arm key
OG002
arm label
Cohort 1
regimen
Non-cryopreserved LN-144 (Gen 1 infusion product)
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0003
arm key
OG000
arm label
Cohort 2
regimen
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
analyzed count
66
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
outcome key
om-0003
arm key
OG001
arm label
Cohort 4
regimen
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02360579-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
harm key
EG000
source section id
NCT02360579-ae
event group key
EG000
event group label
Cohort 1
serious affected
9
serious at risk
23
other affected
23
other at risk
23
frequency threshold
5
collection period
From enrollment to end of follow-up (up to 5 years)
event definition
Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
harm key
EG001
source section id
NCT02360579-ae
event group key
EG001
event group label
Cohort 2
serious affected
23
serious at risk
67
other affected
67
other at risk
67
frequency threshold
5
collection period
From enrollment to end of follow-up (up to 5 years)
event definition
Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
harm key
EG002
source section id
NCT02360579-ae
event group key
EG002
event group label
Cohort 3
serious affected
2
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
From enrollment to end of follow-up (up to 5 years)
event definition
Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02360579
harm key
EG003
source section id
NCT02360579-ae
event group key
EG003
event group label
Cohort 4
serious affected
31
serious at risk
89
other affected
89
other at risk
89
frequency threshold
5
collection period
From enrollment to end of follow-up (up to 5 years)
event definition
Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice