A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.
1 other identifier
interventional
60
1 country
12
Brief Summary
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2024
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 1, 2024
CompletedStudy Start
First participant enrolled
October 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
October 30, 2025
October 1, 2025
3.5 years
June 25, 2024
October 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.
Up to 5 Years
Secondary Outcomes (6)
Complete Response Rate
Up to 5 Years
Duration of Response
Up to 5 Years
Disease Control Rate
Up to 5 Years
Progression-Free Survival
Up to 5 Years
Overall Survival
Up to 5 Years
- +1 more secondary outcomes
Study Arms (1)
Patients with Endometrial Cancer
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Participants must have a histologically confirmed diagnosis of endometrial carcinoma. All histologies, including carcinosarcoma, will be allowed. Uterine sarcoma will not be allowed.
- 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.
- Participants who declined platinum-based chemotherapy regimen and/or an anti-PD-1/PD-L1 therapy or were deemed ineligible for such therapies by the investigator may be considered after discussion with the medical monitor.
- Systemic therapy counting towards lines of therapy includes chemotherapy, targeted therapy, immunotherapy, and antibody drug conjugates, given alone or in combination. Hormonal therapy does not count as a line of therapy.
- Participants must have either (i) documented radiographic disease progression during or after the last line of therapy or (ii) discontinued their last line of therapy because of treatment intolerance or toxicity or (iii) with medical monitor discussion, participant/physician decision in the context of stable disease with evidence of tumor growth.
- Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and estimated life expectancy of \>6 months.
- Participants having at least one resectable lesion and at least one measurable lesion, following resection of the lesion for TIL generation.
- Participants who have adequate organ function, including adequate cardiopulmonary function.
- Participants of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after the last dose of study intervention.
- Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
You may not qualify if:
- Participants who have symptomatic untreated brain metastases.
- Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
- Participants who require systemic steroid therapy \> 10 mg/day prednisone or another steroid equivalent dose.
- Participants who have any form of primary immunodeficiency.
- Participants who have another primary malignancy within the previous 3 years.
- Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMALD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Honor Health
Phoenix, Arizona, 85016, United States
University of Southern California
Los Angeles, California, 90007, United States
Orlando Health
Orlando, Florida, 32806, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, 33612, United States
Augusta University
Augusta, Georgia, 30912, United States
UofL Health - Brown Cancer Center
Louisville, Kentucky, 40202, United States
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201, United States
Roswell Park Cancer Institute
Buffalo, New York, 14203, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73117, United States
Allegheny Health
Pittsburgh, Pennsylvania, 15524, United States
Avera Medical Group Oncology
Sioux Falls, South Dakota, 57105, United States
MD Anderson Cancer Center - U of Texas
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iovance Biotherapeutics Study Team
Iovance Biotherapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2024
First Posted
July 1, 2024
Study Start
October 29, 2024
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
November 1, 2029
Last Updated
October 30, 2025
Record last verified: 2025-10