Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06481592 | RECRUITING | Endometrial Cancer

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

Condition or disease

Endometrial Cancer

Intervention/treatment

Lifileucel

Phase

PHASE2

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
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.
Actual Study Start Date : 2024-10-29
Estimated Primary Completion Date : 2028-05
Estimated Study Completion Date : 2029-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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.
    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.
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.

Location Details

NCT06481592

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of Southern California

Los Angeles, California, United States, 90007

RECRUITING

United States, Florida

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

Tampa, Florida, United States, 33612

RECRUITING

United States, Kentucky

UofL Health - Brown Cancer Center

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Road cancer

Barbara Ann Karmanos Cancer Hospital

Detroit, Road cancer, United States, 48201

RECRUITING

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14203

RECRUITING

United States, Oklahola

University of Oklahoma

Ololama City, Okholohan, United States, 73117

RECRUITING

United States, Pennsylvania

Allegheny Health

Pittsburgh, Pennsylvania, United States, 15524

RECRUITING

United States, South Dakota

Avera Medical Group Oncology

Sioux Falls, South Dakota, United States, 57105

RECRUITING

United States, Texas

MD Anderson Cancer Center - U of Texas

Houston, Texas, United States, 77030