Study on TIL Therapy for Skin and Merkel Cell Cancer

Sponsor: Karam Khaddour, MD, MS

Sponsor score: 0

ClinicalTrials ID:NCT07288073

Provider View

This clinical trial is testing a new treatment using tumor-infiltrating lymphocytes (TIL) combined with chemotherapy and Interleukin-2 (IL-2) to see if it is safe and effective for patients with certain skin cancers that have not responded to previous immunotherapy.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a treatment involving tumor-infiltrating lymphocytes (TIL), chemotherapy, and Interleukin-2 (IL-2) for patients with cutaneous squamous cell carcinoma (CSCC) or Merkel Cell Carcinoma (MCC) who have previously been treated with immunotherapy. TIL therapy involves using a patient's own immune cells, which are grown in a lab to increase their ability to fight cancer, and then reintroduced into the body. The chemotherapy drugs Fludarabine and Cyclophosphamide are used to prepare the body for TIL therapy. Although TIL therapy is not yet approved for CSCC or MCC, it has been approved for treating advanced melanoma. The study will involve various tests and procedures to monitor the participants' health and the treatment's effects.

Description

This clinical trial is testing a new treatment approach for patients with certain types of skin cancer, specifically cutaneous squamous cell carcinoma (CSCC) and Merkel Cell Carcinoma (MCC), who have not responded to previous immunotherapy treatments. The treatment involves using tumor-infiltrating lymphocytes (TIL), which are a type of immune cell that can attack cancer cells. These cells are collected from the patient, grown in a lab to increase their numbers, and then given back to the patient along with chemotherapy and Interleukin-2 (IL-2) to help the immune system fight the cancer more effectively.

The study will include about 14 participants and will involve several steps, including screening for eligibility, in-clinic visits, and various tests such as blood tests, scans, and heart and lung function tests. The goal is to determine if this combination of treatments is safe and can help control the cancer. The study is supported by Iovance Biotherapeutics, Inc., which is providing the study therapy and funding.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of cutaneous squamous cell carcinoma (CSCC) or Merkel Cell Carcinoma (MCC).
  • Cancer must be unresectable, recurrent, or metastatic.
  • Must have shown disease progression after previous immunotherapy treatment.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have at least one tumor that can be surgically removed for TIL production.
  • Must have adequate blood cell counts and organ function.
  • Must have good heart and lung function.
  • Must have completed any previous cancer treatments at least 21 days before starting the study.
  • Must be willing to use effective birth control during and after the study.

Exclusion Criteria

  • History of organ transplant.
  • Untreated or symptomatic brain metastases.
  • Need for high-dose steroid therapy.
  • Active infections requiring treatment.
  • Pregnant or breastfeeding women.
  • Serious medical conditions that increase risk.
  • Recent live vaccinations.
  • Primary immunodeficiency disorders.
  • History of severe allergic reactions to study drugs.
  • Recent history of other cancers, unless treated and not at risk of recurrence.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02215BostonMassachusetts

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