The purpose of this research study is to test the safety and effectiveness of a tumor-infiltrating lymphocyte (TIL) cellular therapy, also called LN-145 or lifileucel, and chemotherapy in combination with Interleukin-2 (IL-2) to find out what effects, if any, the combination has on participants with Cutaneous squamous cell carcinoma (CSCC) or Merkel Cell Carcinoma (MCC) who were previously treated with immunotherapy.
The names of the study interventions involved in this study are:
* Tumor Infiltrating Lymphocytes (a type of cellular therapy) * Fludarabine and Cyclophosphamide (types of standard of care chemotherapy drugs) * Interleukin-2 (a type of recombinant, human glycoprotein)
Provide written informed consent, which includes understanding that there may be a need for intensive supportive care measures during the study and assessing willingness to undergo such measures, and written authorization for use and disclosure of protected health information.
Patients must be ≥ than 18 years of age at the time of signing the informed consent form.
Patients must have histologically or pathologically confirmed diagnosis of CSCC or MCC. Note: Mixed histology is allowed. Note: Neuroendocrine cancer that is clinically considered to be related to a cutaneous primary (MCC) or induced by sun damage (per investigator assessment) is allowed.
Patients must have unresectable, recurrent, or metastatic disease.
Have a history of allogenic organ transplant.
Patients with asymptomatic brain metastases that are treated and have been stable for at least 7 days may be enrolled.
Patients with historically or recently treated brain metastases will be considered for enrollment if the patient is clinically stable for ≥ 2 weeks, and the patient does not require ongoing corticosteroid treatment (>10 mg/day prednisone or its equivalent).
Patients who undergo tumor harvest prior to disease progression and develop symptomatic brain metastases after tumor harvest should have receive appropriate treatment for ≥ 2 weeks and not require corticosteroids (>10 mg/day or its equivalent) at the start of NMA-LD (Day -5).
Karam Khaddour, MD, MS
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Iovance Biotherapeutics, Inc.
Collaborator