Study on Lifileucel with Reduced Dose Chemotherapy and Interleukin-2 for Treating Unremovable or Spread Melanoma

Sponsor: University of Kansas Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06151847

Provider View

This clinical trial is testing a new treatment using lifileucel, a type of immune cell therapy, combined with lower doses of chemotherapy and interleukin-2, to treat melanoma that cannot be surgically removed or has spread to other parts of the body.

Patient Parameters

Program Overview

This phase II study is exploring how well lifileucel, along with reduced doses of chemotherapy drugs fludarabine and cyclophosphamide, and interleukin-2, works in treating patients with melanoma that cannot be removed by surgery or has spread to other areas. Lifileucel is made from a patient's own immune cells, which are taken from their tumor, grown in a lab, and then infused back into the patient to help attack the cancer. The study aims to see if this combination can effectively treat unresectable or metastatic melanoma.

Description

The main goal of this study is to see how many of the immune cells (TIL clones) from the lifileucel treatment match those in the patient's blood. Researchers also want to evaluate how effective lifileucel is when used with reduced chemotherapy doses in treating melanoma that cannot be removed or has spread. They will look at how many patients respond to the treatment, how long they live without the cancer getting worse, and their overall survival. Additionally, the study will assess the safety of this treatment combination.

Patients will first undergo surgery to remove a tumor. After about four weeks, they will receive chemotherapy drugs cyclophosphamide and fludarabine through an IV for a few days, followed by an infusion of lifileucel. Patients will also receive up to six doses of interleukin-2 through an IV.

After completing the treatment, patients will have follow-up visits at various intervals to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 years or older. Patients over 70 may be included at the discretion of the lead doctor.
  • Must be in good general health, with a performance status score of 0 or 1.
  • Must have at least one measurable tumor, as defined by specific medical criteria.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Must have melanoma that cannot be removed by surgery or has spread (stage IIIc or IV).
  • Must have previously tried 1-3 other treatments, including a PD-1 blocking antibody, and if they have a BRAF mutation, a BRAF inhibitor or a combination with a MEK inhibitor.
  • Must have at least one tumor that can be surgically removed to create the lifileucel treatment.
  • Must have good blood and organ function.
  • Must have recovered from any side effects of previous treatments to a mild level, except for hair loss or skin color changes.
  • Must have a break of at least 28 days from previous cancer treatments before starting the study treatment.
  • Must agree to use effective birth control during the study and for 12 months after the last dose of interleukin-2.

Exclusion Criteria

  • Cannot use other cancer treatments or experimental drugs during the study.
  • Cannot be pregnant or breastfeeding.
  • Cannot have active medical conditions that increase the risk of participating, such as infections requiring antibiotics or major heart, lung, or immune system illnesses.
  • Cannot have a BRAF mutation and not have tried a BRAF inhibitor treatment.
  • Cannot have received an organ transplant or previous cell therapy.
  • Cannot have melanoma that started in the eye.
  • Cannot have allergies to any part of the lifileucel treatment or other study drugs.
  • Cannot have immune system deficiencies like SCID or AIDS.
  • Cannot have a heart function below 45% or significant heart disease.
  • Cannot have a lung function below 60%.
  • Cannot have had another cancer in the past three years, except for certain treated cancers.
  • Cannot have untreated or symptomatic brain metastases.

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