The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
The study will enroll participants with advanced endometrial cancer who previously received treatment with platinum-based chemotherapy and an anti-programmed cell death protein-1 (PD-1)/programmed death ligand 1 (PD-L1) agent in a recurrent or advanced setting, either sequentially or in combination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with lifileucel, followed by IL-2.
Honor Health
Phoenix, Arizona, United States
RECRUITINGUniversity of Southern California
Los Angeles, California, United States
Objective Response Rate
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.
Time frame: Up to 5 Years
Complete Response Rate
To evaluate the proportion of participants who have a confirmed complete response (CR) per RECIST v1.1.
Time frame: Up to 5 Years
Duration of Response
To measure from the first time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1.
Time frame: Up to 5 Years
Disease Control Rate
To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RICIST v1.1.
Time frame: Up to 5 Years
Progression-Free Survival
To evaluate the time from the date of the lifileucel infusion until disease progression per RECIST v1.1.
Time frame: Up to 5 Years
Overall Survival
To measure the time from the date of lifileucel infusion to death due to any cause.
Time frame: Up to 5 Years
Adverse Events
To characterize the safety and tolerability profile of lifileucel in participants with advanced endometrial cancer.
Time frame: Up to 5 Years
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Orlando Health
Orlando, Florida, United States
RECRUITINGH. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, United States
RECRUITINGAugusta University
Augusta, Georgia, United States
RECRUITINGUofL Health - Brown Cancer Center
Louisville, Kentucky, United States
RECRUITINGBarbara Ann Karmanos Cancer Hospital
Detroit, Michigan, United States
RECRUITINGRoswell Park Cancer Institute
Buffalo, New York, United States
RECRUITINGUniversity of Oklahoma
Oklahoma City, Oklahoma, United States
RECRUITINGAllegheny Health
Pittsburgh, Pennsylvania, United States
RECRUITING...and 2 more locations