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Using lifileucel to treat advanced endometrial cancer

A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.

Phase 2 Interventional Iovance Biotherapeutics, Inc. · NCT06481592

This study is testing if a new cell therapy called lifileucel can help adults with advanced endometrial cancer who haven't responded to other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 70 Years
SexFemale
SponsorIovance Biotherapeutics, Inc. Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, prednisone
Locations12 sites (Phoenix, Arizona and 11 other locations)
Trial IDNCT06481592 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of lifileucel, a type of cell therapy using tumor-infiltrating lymphocytes, in adults with advanced endometrial cancer who have previously been treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors. Participants will be enrolled if they have documented disease progression after these treatments. The study aims to determine how well lifileucel can help manage this challenging cancer type.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced endometrial cancer who have previously received specific treatments and have documented disease progression.

Not a fit: Patients with uterine sarcoma or those who have not received prior platinum-based chemotherapy and anti-PD-1/PD-L1 therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced endometrial cancer who have limited treatment choices.

How similar studies have performed: Other studies using tumor-infiltrating lymphocytes for cancer treatment have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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.
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.

Where this trial is running

Phoenix, Arizona and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Endometrial CancerTumor Infiltrating LymphocytesTILEndometrialCell TherapyCellular ImmunotherapyIL-2Non-myeloablative lymphodepletion
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.