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

Recruiting now · Phase 2

Conditions studied: Endometrial Cancer

In brief

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

Key facts

Study ID

NCT06481592

Run by

Iovance Biotherapeutics, Inc.

People needed

60

Starts

2024-10-29

Expected to finish

2029-11-01

Last updated by the study team

2025-10-30

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Honor Health — Phoenix, Arizona, United States (enrolling)
• University of Southern California — Los Angeles, California, United States (enrolling)
• Orlando Health — Orlando, Florida, United States (enrolling)
• H. Lee Moffitt Cancer Center and Research Institute, Inc. — Tampa, Florida, United States (enrolling)
• Augusta University — Augusta, Georgia, United States (enrolling)
• UofL Health - Brown Cancer Center — Louisville, Kentucky, United States (enrolling)
• Barbara Ann Karmanos Cancer Hospital — Detroit, Michigan, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
• Allegheny Health — Pittsburgh, Pennsylvania, United States (enrolling)
• Avera Medical Group Oncology — Sioux Falls, South Dakota, United States (enrolling)
• MD Anderson Cancer Center - U of Texas — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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