Expanded Access to Lifileucel to Treat Inoperable or Metastatic Melanoma

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Full Title

An Expanded Access Program of Lifileucel, Autologous Tumor Infiltrating Lymphocytes (TIL LN-144), for Patients with Unresectable or Metastatic Melanoma (EAP)

Purpose

The purpose of this study is to provide expanded access to a treatment called lifileucel for people with melanoma that cannot be surgically removed or has spread to other parts of the body and has continued to grow during standard immunotherapy. Lifileucel is called “autologous tumor-infiltrating lymphocytes” (TIL) therapy. TIL therapies are made in a laboratory from white blood cells called lymphocytes (or T cells) that will be collected from each patient’s tumor. Lifileucel is designed to selectively attack cancer cells while leaving healthy cells alone.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic melanoma that continues to grow despite one to four prior regimens of treatment that included immunotherapy. Additional lines of therapy (more than 4 prior regimens) may be permitted on a case-by-case basis.
  • Participants must have at least one tumor that can be surgically removed, to produce the lifileucel.
  • Patients must not have active (growing) brain metastases. If the melanoma has spread to the brain, it must be treated and stable before a patient could be considered for this treatment.
  • The serious side effects of previous therapies should go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Allison Betof Warner at 646-888-6854.

Protocol

22-198

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases