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.
- 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.
Exclusion criteria
- 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.
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