Study on Lifileucel (Tumor-infiltrating Lymphocytes) for Adults with Advanced Endometrial Cancer
Sponsor: Iovance Biotherapeutics, Inc.
ClinicalTrials ID:NCT06481592
This clinical trial is exploring the effectiveness and safety of a treatment called lifileucel for adults with advanced endometrial cancer who have already received certain treatments.
Patient Parameters
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Program Overview
The aim of this study is to test how well a treatment called lifileucel works and how safe it is for patients with advanced endometrial cancer. Participants in this study will have previously been treated with platinum-based chemotherapy and a type of immunotherapy that targets proteins called PD-1 or PD-L1, either together or separately.
Description
This study is for adults with advanced endometrial cancer who have already tried other treatments. Participants will have received platinum-based chemotherapy and an anti-PD-1/PD-L1 therapy, which are common treatments for this type of cancer. The study will look at how effective the lifileucel treatment is in shrinking tumors and improving patient outcomes. Participants will need to have at least one tumor that can be removed and another that can be measured for the study. The study will also ensure that participants have good overall health and organ function before starting the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of endometrial cancer, including carcinosarcoma, but not uterine sarcoma.
- Have received up to 3 different treatments for cancer that has come back, spread, or cannot be removed by surgery, with no more than 1 being chemotherapy.
- Must have tried platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either together or separately, and the cancer must have gotten worse during or after these treatments.
- Must be in good general health, with an ECOG performance status of 0 or 1, and expected to live more than 6 months.
- Must have at least one tumor that can be removed and another that can be measured after removal.
- Must have good organ function, including heart and lung health.
- Women who can have children must agree to use effective birth control during the study and for 12 months after the last treatment.
- Participants over 70 years old may join after discussion with the study doctor.
Exclusion Criteria
- Have untreated brain cancer that is causing symptoms.
- Have had an organ transplant or cell therapy with chemotherapy in the last 20 years.
- Need to take more than 10 mg of prednisone or an equivalent steroid daily.
- Have a primary immune system disorder.
- Have had another type of cancer in the last 3 years.
- Have received a live vaccine within 28 days before starting the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Southern California | 90007 | Los Angeles | California |
| UofL Health - Brown Cancer Center | 40202 | Louisville | Kentucky |
| Roswell Park Cancer Institute | 14203 | Buffalo | New York |
| Allegheny Health | 15524 | Pittsburgh | Pennsylvania |
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