IOV-END-201 Study Overview

ABOUT THE STUDY

The IOV-END-201 study is currently enrolling adults in the US who have been diagnosed with advanced endometrial cancer. It is evaluating whether lifileucel, an investigational tumor infiltrating lymphocyte (TIL) cell therapy, can offer a new way to help the body fight endometrial cancer. Lifileucel is being developed for people with advanced endometrial cancer whose disease has progressed after prior treatment.

  • All participants will receive lifileucel
  • Participants will receive care from a team of healthcare providers trained in oncology and clinical research
  • Participants are free to stop participating in the study at any time, for any reason


What is lifileucel?

Lifileucel is an investigational cell therapy made from a person’s own immune cells (TIL cells), which are collected from a tumor. These T cells are expanded and activated in a lab before being returned to the body to help fight cancer. Lifileucel has already been studied in other solid tumors, such as melanoma.

Lifileucel is investigational and not approved by any regulatory agency for use in endometrial cancer. Its safety and efficacy in endometrial cancer are still being studied.

WHAT PARTICIPANTS CAN EXPECT IN THE IOV-END-201 STUDY

Screening

Participants will go through screening to confirm eligibility. This may include physical exams, blood tests, and imaging tests.

Study treatment

If eligible, participants will:

  • Undergo tumor resection
  • Receive lymphodepleting chemotherapy, a short course of chemotherapy that helps to prepare the body to receive the lifileucel cells
  • Receive an infusion of lifileucel, in which their own immune cells are returned to their body to help recognize and fight the cancer
  • Receive lymphodepleting chemotherapy, which is a short course of high-dose interleukin-2 (IL-2), a medication that supports immune cell activity

Participants will be closely monitored throughout the process by a dedicated study team.

WHO CAN PARTICIPATE

Participants may be eligible if they:

  • Are 18 years of age or older
  • Were informed by their healthcare provider that the endometrial cancer cannot be removed with surgery or has spread to other parts of their body
  • Have received at least 1 prior line of platinum-based chemotherapy and immune checkpoint inhibitor (ICI) therapy
  • Meet additional health and safety criteria

Full eligibility criteria should be discussed with participants during their screening.

 

FREQUENTLY ASKED PARTICIPANTS QUESTIONS

Do I have to pay to be in this study?
No. Patients will not be charged for lifileucel or study-related care. Standard medical care outside the study may be billed to patients or their insurance.

Can I stop participating?
Yes, participation is completely voluntary. Participants can stop at any time without affecting future medical care.

Can I take other medications?
Participants must tell the study team about any medications or supplements they are taking. Some may need to be stopped or adjusted during the study.

Are there risks?
All clinical trials involve risks. Their healthcare provider will discuss potential side effects and closely monitor their health.

Will I benefit from participating?
Participants may experience a benefit, but there is no guarantee. Additionally, participation may help advance treatment options for others with endometrial cancer.

 

INFORMATION AND RESOURCES

Want to learn more or find out if a participant may qualify?

Contact Iovance at:

1-844-845-4682

Visit the official clinical trial listing:

clinicaltrials.gov/NCT06481592

Learn more about clinical trials in general:

clinicaltrials.gov/study-basics/learn-about-studies

 

STUDY LOCATIONS

This study has 7 locations in the United States

California Locations
Los Angeles, California, United States, 90007
Recruiting
University of Southern California

Kentucky Locations
Louisville, Kentucky, United States, 40202
Recruiting
UofL Health – Brown Cancer Center

Michigan Locations
Detroit, Michigan, United States, 48201
Recruiting
Barbara Ann Karmanos Cancer Hospital

New York Locations
Buffalo, New York, United States, 14203
Recruiting
Roswell Park Cancer Institute

Oklahoma Locations
Oklahoma City, Oklahoma, United States, 73117
Recruiting
University of Oklahoma

Pennsylvania Locations
Pittsburgh, Pennsylvania, United States, 15524
Recruiting
Allegheny Health

Texas Locations
Houston, Texas, United States, 77030
Recruiting
MD Anderson Cancer Center – U of Texas

For an up-to-date list of sites, please visit:

clinicaltrials.gov/NCT06481592

New locations may be added, so check back regularly or call the study line for the latest information.