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Trial Title:
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
NCT ID:
NCT06481592
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
Tumor Infiltrating Lymphocytes
TIL
Endometrial Cancer
Endometrial
Cell Therapy
Cellular Immunotherapy
IL-2
Non-myeloablative lymphodepletion (NMALD)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Lifileucel
Description:
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.
Arm group label:
Patients with Endometrial Cancer
Other name:
Tumor-Infiltrating Lymphocytes
Other name:
TIL
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.
Criteria for eligibility:
Criteria:
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 therapy:
- Up to 3 lines of systemic therapy with no more than 1 line of chemotherapy for
recurrent, metastatic, or primary unresectable disease. Prior hormonal therapy
is allowed and do not count as prior lines of therapy.
- Participants have progressed on or after platinum-based chemotherapy and
anti-PD-1/PD-L1 therapy. Platinum-based chemotherapy and anti-PD-1/PD-L1
therapy may have been given together or in separate lines of therapy.
- Participants must have documented radiographic disease progression during or
after the last line of therapy.
3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance
status of 0 or 1 and estimated life expectancy of >6 months.
4. Participants having at least one resectable lesion and at least one measurable
lesion, following resection of the lesion for TIL generation.
5. Participants who have adequate organ function, including adequate cardiopulmonary
function.
6. 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.
7. Participants who are >70 years of age may be allowed to enroll after the
investigator discusses with the medical monitor.
Exclusion Criteria:
1. Participants who have symptomatic untreated brain metastases.
2. 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.
3. Participants who require systemic steroid therapy > 10 mg/day prednisone or another
steroid equivalent dose.
4. Participants who have any form of primary immunodeficiency.
5. Participants who have another primary malignancy within the previous 3 years.
6. Participants who have received or will receive a live or attenuated vaccination
within 28 days prior to the start of the NMALD.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UofL Health - Brown Cancer Center
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Recruiting
Facility:
Name:
Allegheny Health
Address:
City:
Pittsburgh
Zip:
15524
Country:
United States
Status:
Recruiting
Start date:
October 2024
Completion date:
November 2029
Lead sponsor:
Agency:
Iovance Biotherapeutics, Inc.
Agency class:
Industry
Source:
Iovance Biotherapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06481592
