NCT06481592RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 30 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- 29 Oct 2024
- Primary completion date
- May 2028
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Diseases
- Endometrial cancer
- NCT number
- NCT06481592
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 29 Oct 2024 to the primary completion date, May 2028
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other
- Participants who have symptomatic untreated brain metastases.
- Participants who have any form of primary immunodeficiency.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| Barbara Ann Karmanos Cancer Hospital Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| MD Anderson Cancer Center - U of Texas Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| UofL Health Brown Cancer Center Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| University of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Orlando Health Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Honor Health Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Allegheny Health Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Avera Medical Group Oncology Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| H. Lee Moffitt Cancer Center and Research Institute, Inc Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.