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

Phase 2

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Biological: Lifileucel

• Registration Number: NCT06481592
• Lead Sponsor: Iovance Biotherapeutics, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-01
• Study Start: 2024-10-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2028-05
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 therapy:

   • Up to 3 lines of systemic therapy with no more than 1 line of chemotherapy for recurrent, metastatic, or primary unresectable disease. Prior hormonal therapy is allowed and do not count as prior lines of therapy.
   • Participants have progressed on or after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Platinum-based chemotherapy and anti-PD-1/PD-L1 therapy may have been given together or in separate lines of therapy.
   • Participants must have documented radiographic disease progression during or after the last line of therapy.

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Endometrial Cancer	Lifileucel	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	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.

Secondary Outcome Measures

Name	Time	Method
Complete Response Rate	Up to 5 Years	To evaluate the proportion of participants who have a confirmed complete response (CR) per RECIST v1.1.
Overall Survival	Up to 5 Years	To measure the time from the date of lifileucel infusion to death due to any cause.
Duration of Response	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.
Disease Control Rate	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.
Progression-Free Survival	Up to 5 Years	To evaluate the time from the date of the lifileucel infusion until disease progression per RECIST v1.1.
Adverse Events	Up to 5 Years	To characterize the safety and tolerability profile of lifileucel in participants with advanced endometrial cancer.

Trial Locations

Locations (4)

University of Southern California; 🇺🇸 Los Angeles, California, United States

UofL Health - Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Allegheny Health; 🇺🇸 Pittsburgh, Pennsylvania, United States