A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.
Summary
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
Detailed description
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.
Arms & interventions
- BiologicalLifileucel
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.
Outcome measures
Primary
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
Secondary
Complete Response Rate
Time frame: Up to 5 Years
Duration of Response
Time frame: Up to 5 Years
Disease Control Rate
Time frame: Up to 5 Years
Progression-Free Survival
Time frame: Up to 5 Years
Overall Survival
Time frame: Up to 5 Years
Adverse Events
Time frame: Up to 5 Years
Eligibility criteria
Study locations (12)
Honor Health
Phoenix, Arizona, 85016
University of Southern California
Los Angeles, California, 90007
Orlando Health
Orlando, Florida, 32806
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, 33612
Augusta University
Augusta, Georgia, 30912
UofL Health - Brown Cancer Center
Louisville, Kentucky, 40202
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201
Roswell Park Cancer Institute
Buffalo, New York, 14203
University of Oklahoma
Oklahoma City, Oklahoma, 73117
Allegheny Health
Pittsburgh, Pennsylvania, 15524
Avera Medical Group Oncology
Sioux Falls, South Dakota, 57105
MD Anderson Cancer Center - U of Texas
Houston, Texas, 77030