Study on Lifileucel (Tumor-infiltrating Lymphocytes) for Adults with Advanced Melanoma

Sponsor: Iovance Biotherapeutics, Inc.

Sponsor score: 60

ClinicalTrials ID:NCT07288203

Provider View

This clinical trial is testing a new treatment called lifileucel, which uses a type of immune cell therapy, for adults with advanced melanoma who have already received other treatments.

Patient Parameters

Program Overview

This Phase 2 study is exploring the use of lifileucel, a treatment involving tumor-infiltrating lymphocytes (TIL), in adults with advanced melanoma that has not responded to previous treatments. The study is open to participants who have tried at least one prior treatment with anti-PD-1 or anti-PD-L1 therapies, and for those with a specific BRAF mutation, an additional treatment with BRAF and possibly MEK inhibitors.

Description

The study focuses on lifileucel, a treatment that uses a patient's own immune cells to fight melanoma, a type of skin cancer that has spread or cannot be removed by surgery. Participants must have previously tried treatments that target specific proteins involved in cancer growth, such as PD-1 or PD-L1 inhibitors. Those with a BRAF V600 mutation may have also tried treatments targeting this mutation. The study aims to see if lifileucel can help control the cancer in these patients. Participants will need to have at least one tumor that can be surgically removed to create the lifileucel treatment and must be willing to receive supportive care during the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced melanoma that cannot be surgically removed or has spread (Stage IIIC, IIID, or IV).
  • Good overall health with a performance status of 0 or 1 and expected to live more than 6 months.
  • Cancer has progressed after trying at least one treatment with anti-PD-1 or anti-PD-L1 therapies, or within 12 weeks after such treatment.
  • For those with BRAF V600 mutation, may have tried additional treatments with BRAF and possibly MEK inhibitors.
  • Must have at least one tumor that can be removed for creating the lifileucel treatment.
  • Must have measurable disease after tumor removal.
  • Participants over 70 may join after discussion with the study team.
  • Must agree to use effective birth control if of childbearing potential.
  • Must have adequate organ function.
  • Willing to receive supportive care during the study.

Exclusion Criteria

  • Melanoma originating from the eye.
  • Untreated brain tumors causing symptoms.
  • Active eye inflammation requiring treatment.
  • Serious medical conditions that increase study risks, such as infections or heart, lung, or immune system diseases.
  • Any form of immune system deficiency.
  • Another cancer within the last 3 years, unless it was treated and not expected to return.
  • History of organ or cell transplants.
  • Currently in another clinical trial, unless it's non-interventional or in the follow-up phase.

Locations

FACILITYZIPCITYSTATE
Sarah Cannon Research Institute37203NashvilleTennessee

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