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

October 29, 2025 updated by: Iovance Biotherapeutics, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Honor Health
    • California
      • Los Angeles, California, United States, 90007
        • Recruiting
        • University of Southern California
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H. Lee Moffitt Cancer Center and Research Institute, Inc.
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • UofL Health - Brown Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Barbara Ann Karmanos Cancer Hospital
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Roswell Park Cancer Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Recruiting
        • University of Oklahoma
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15524
        • Recruiting
        • Allegheny Health
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Medical Group Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center - U of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with Endometrial Cancer
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.
Other Names:
  • TIL
  • Tumor-Infiltrating Lymphocytes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: Up to 5 Years
To evaluate the proportion of participants who have a confirmed complete response (CR) per RECIST v1.1.
Up to 5 Years
Duration of Response
Time Frame: Up to 5 Years
To measure from the first time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1.
Up to 5 Years
Disease Control Rate
Time Frame: Up to 5 Years
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.
Up to 5 Years
Progression-Free Survival
Time Frame: Up to 5 Years
To evaluate the time from the date of the lifileucel infusion until disease progression per RECIST v1.1.
Up to 5 Years
Overall Survival
Time Frame: Up to 5 Years
To measure the time from the date of lifileucel infusion to death due to any cause.
Up to 5 Years
Adverse Events
Time Frame: Up to 5 Years
To characterize the safety and tolerability profile of lifileucel in participants with advanced endometrial cancer.
Up to 5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iovance Biotherapeutics, Inc.

Investigators

  • Study Director: Iovance Biotherapeutics Study Team, Iovance Biotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOV-END-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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