NCT06481592 · Iovance Biotherapeutics, Inc.
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
What this study is about
The purpose of this study is to investigate the effectiveness and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
View original scientific description
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
Interventions
BIOLOGICAL
Lifileucel
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.
Primary outcome measures
Objective Response Rate
Time frame: Up to 5 Years
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 lea
Where
- Phoenix, Arizona
- Los Angeles, California
- Orlando, Florida
- Tampa, Florida
- Augusta, Georgia
- Louisville, Kentucky
- Detroit, Michigan
- Buffalo, New York
- Oklahoma City, Oklahoma
- Pittsburgh, Pennsylvania
- Sioux Falls, South Dakota
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2025 · Source of record for eligibility and locations