This is a Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes \[TIL\]) in participants with previously treated advanced melanoma
This is a Phase 2 study of the lifileucel treatment regimen in participants who previously received treatment for unresectable or metastatic (advanced) melanoma with 1 prior line of an anti-programmed cell death protein-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) agent or whose melanoma progressed during and/or within ≤ 12 weeks after adjuvant anti-PD-(L)1 treatment (early relapse). Participants who have BRAF V600 mutation positive melanoma may have received or refused 1 additional prior line treatment with a BRAF inhibitor ± a MEK inhibitor
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
A tumor sample is resected from each patient for lifileucel manufacturing. Patients will first receive the preparative non-myeloablative lymphodepletion (NMA-LD) regimen. They will then receive the lifileucel infusion, followed by an abbreviated course of aldesleukin.
Sarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGGreenslopes Private Hospital
Greenslopes, Queensland, Australia
RECRUITINGPrincess Margaret Cancer Centre
Toronto, Ontario, Canada, Canada
Objective Response Rate
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC
Time frame: 5 years
Complete Response Rate
To evaluate the efficacy of lifileucel as measured by CR rate per RECIST v1.1 as assessed by the IRC
Time frame: 5 years
Duration of Response
To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the IRC
Time frame: 5 years
Disease Control Rate
To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the IRC
Time frame: 5 years
Progression-Free Survival
To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the IRC
Time frame: 5 years
Objective Response Rate
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the investigators
Time frame: 5 years
Complete Response Rate
To evaluate the efficacy of lifileucel as measured CR rate per RECIST v1.1 as assessed by the investigators
Time frame: 5 years
Duration of Response
To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the investigators
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Centre Hospitalier de l'Universite de Montreal
Montral, Quebec, Canada, Canada
RECRUITINGRoyal Marsden Hospital
London, United Kingdom
RECRUITINGTime frame: 5 years
Disease Control Rate
To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the investigators
Time frame: 5 years
Progression-Free Survival
To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the investigators
Time frame: 5 years
Overall Survival
To evaluate the efficacy of lifileucel as measured by OS
Time frame: 5 years
Adverse Events
To demonstrate safety and tolerability of lifileucel
Time frame: 5 years