A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.
Iovance Biotherapeutics, Inc.
Summary
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
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.
Eligibility
- Age range
- 18–70 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must have a histologically confirmed diagnosis of endometrial carcinoma. All histologies, including carcinosarcoma, will be allowed. Uterine sarcoma will not be allowed. 2. Participants who have received the following previous therapies: * At least 1 but no more than 4 lines of prior systemic therapy with no more than 2 lines of chemotherapy in any setting (ie, neoadjuvant or adjuvant setting as well as for recurrent, metastatic, or primary unresectable disease. . * Participants have received platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.…
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.
Locations (12)
- Honor HealthPhoenix, Arizona
- University of Southern CaliforniaLos Angeles, California
- Orlando HealthOrlando, Florida
- H. Lee Moffitt Cancer Center and Research Institute, Inc.Tampa, Florida
- Augusta UniversityAugusta, Georgia
- UofL Health - Brown Cancer CenterLouisville, Kentucky