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Endometrial CancerPhase 2NCT06481592

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

A Phase 2 study testing Lifileucel in people with Endometrial Cancer, run by Iovance Biotherapeutics, Inc. at 12 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Lifileucel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
12 sitesUnited States
Study dates
29 Oct 2024to Nov 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Iovance Biotherapeutics Study Team contact

1-844-845-4682

Clinical.Inquiries@iovance.com

12 sites in 1 country

United States12 sites, 12 recruiting

  • Augusta University

    Augusta, Georgia, 30912

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14203

    Recruiting

  • Barbara Ann Karmanos Cancer Hospital

    Detroit, Michigan, 48201

    Recruiting

  • MD Anderson Cancer Center - U of Texas

    Houston, Texas, 77030

    Recruiting

  • University of Southern California

    Los Angeles, California, 90007

    Recruiting

  • UofL Health - Brown Cancer Center

    Louisville, Kentucky, 40202

    Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73117

    Recruiting

  • Orlando Health

    Orlando, Florida, 32806

    Recruiting

  • Honor Health

    Phoenix, Arizona, 85016

    Recruiting

  • Allegheny Health

    Pittsburgh, Pennsylvania, 15524

    Recruiting

  • Avera Medical Group Oncology

    Sioux Falls, South Dakota, 57105

    Recruiting

  • H. Lee Moffitt Cancer Center and Research Institute, Inc.

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

About this study

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

The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.

Read the detailed description

The study will enroll participants with advanced endometrial cancer who previously received treatment with platinum-based chemotherapy and an anti-programmed cell death protein-1 (PD-1)/programmed death ligand 1 (PD-L1) agent in a recurrent or advanced setting, either sequentially or in combination.

Being tested
Lifileucel
Keywords
Tumor Infiltrating Lymphocytes, TIL, Endometrial Cancer, Endometrial, Cell Therapy, Cellular Immunotherapy, IL-2, Non-myeloablative lymphodepletion (NMALD)
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LifileucelBiological

    Also called Tumor-Infiltrating Lymphocytes, TIL

    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.

Study groups in NCT06481592
Study groupRoleWhat they receive
Patients with Endometrial CancerExperimentalNot described
Receives: Biological: Lifileucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

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

    Measured: Up to 5 Years

Secondary outcomes (6)

  1. Complete Response Rate

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

    Measured: Up to 5 Years

  2. Duration of Response

    To measure from the first time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1.

    Measured: Up to 5 Years

  3. Disease Control Rate

    To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RICIST v1.1.

    Measured: Up to 5 Years

  4. Progression-Free Survival

    To evaluate the time from the date of the lifileucel infusion until disease progression per RECIST v1.1.

    Measured: Up to 5 Years

  5. Overall Survival

    To measure the time from the date of lifileucel infusion to death due to any cause.

    Measured: Up to 5 Years

  6. Adverse Events

    To characterize the safety and tolerability profile of lifileucel in participants with advanced endometrial cancer.

    Measured: Up to 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start29 Oct 2024
  3. Primary completionMay 2028 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06481592
Sponsor's protocol ID
IOV-END-201
Status last verified
Oct 2025
First submitted
25 Jun 2024
Last updated
30 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lifileucel in people with Endometrial Cancer, run by Iovance Biotherapeutics, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Iovance Biotherapeutics Study Team (1-844-845-4682, Clinical.Inquiries@iovance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Up to 5 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06481592.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.

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