A study of lifileucel (tumor-infiltrating lymphocytes) in adults with advanced soft tissue sarcoma ('SARATOGA')
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated soft tissue sarcoma. The length of the study for each participant may be up to 5 calendar years after receiving lifileucel. After Screening, each participant will have surgery to remove some tumor pieces that will be used to make the lifileucel, followed by a baseline visit prior to study treatment. Participants will then receive the lifileucel treatment regimen. This includes 2 drugs (cyclophosphamide and fludarabine) for up to 5 days to decrease lymphocytes in the body, the lifileucel infusion (1 day), and up to 4 days of aldesleukin to boost the activity of the lifileucel. Study visits will be every 6 weeks for 6 months, then every 3 months until 5 calendar years after the lifileucel infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Study intervention will begin with a tumor resection from which lifileucel will be generated. The lifileucel regimen consists of a preparative NMA-LD regimen (ie, cyclophosphamide with mesna followed by fludarabine), the lifileucel infusion, and an abbreviated course of aldesleukin (interleukin-2).
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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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 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 evaluate safety and tolerability of lifileucel
Time frame: 5 years