Lifileucel for Advanced Endometrial Cancer

This study is testing a treatment called lifileucel for adults with advanced endometrial cancer that has been previously treated. Lifileucel involves taking a sample of your tumor, growing special immune cells (tumor-infiltrating lymphocytes) from it in a lab, and then giving them back to you after a type of chemotherapy. This is followed by another medicine called IL-2. The main goal is to see how many participants respond to the treatment. You may be able to join if you are a woman between 18 and 70 years old with a confirmed diagnosis of endometrial cancer, and you have received 1 to 4 prior systemic therapies, including platinum-based chemotherapy and an anti-PD-1/PD-L1 agent. The study is currently recruiting participants.

Study design
This interventional study plans to enroll 60 participants. It is investigating the efficacy and safety of the lifileucel regimen.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure the objective response rate.

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NCT06481592

A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Iovance Biotherapeutics, Inc.
~60 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:Lifileucel

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate
Measured over Up to 5 Years
Endometrial Cancer
12 sites across 11 states
Florida2
Arizona1
California1
Georgia1
Kentucky1
Michigan1
New York1
Oklahoma1
  • Iovance Biotherapeutics Study Team · STUDY_DIRECTOR · Iovance Biotherapeutics

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Eligibility criteria

Inclusion

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. 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.
  • Objective Response RateUp to 5 Years

    To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.