RECRUITING

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

Conditions

Endometrial Cancer Tumor Infiltrating Lymphocytes TIL Endometrial Cell Therapy Cellular Immunotherapy IL-2 Non-myeloablative lymphodepletion (NMALD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10

Study Completion:2029-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06481592

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Iovance Biotherapeutics Study Team

CONTACT

1-844-845-4682

Clinical.Inquiries@iovance.com

Principal Investigator

Iovance Biotherapeutics Study Team

STUDY_DIRECTOR

Iovance Biotherapeutics

Study Locations (Sites)

UofL Health - Brown Cancer Center

Louisville, Kentucky, 40202

United States

Roswell Park Cancer Institute

Buffalo, New York, 14203

United States

Allegheny Health

Pittsburgh, Pennsylvania, 15524

United States

Collaborators and Investigators

Sponsor: Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics Study Team, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-10

Study Completion Date2029-11

Study Record Updates

Study Start Date2024-10

Study Completion Date2029-11

Terms related to this study

Keywords Provided by Researchers

Tumor Infiltrating Lymphocytes
TIL
Endometrial Cancer
Endometrial
Cell Therapy
Cellular Immunotherapy
IL-2
Non-myeloablative lymphodepletion (NMALD)

Additional Relevant MeSH Terms

Endometrial Cancer