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A Study of Lifileucel with Cyclophosphamide, Fludarabine, and Aldesleukin for Adults with Previously Treated Advanced Melanoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with advanced melanoma, a type of skin cancer that has spread to other parts of the body or cannot be removed by surgery. The study is looking at a treatment called lifileucel, which is made from a person's own immune cells called tumor-infiltrating lymphocytes. These are special white blood cells that are taken from a tumor that is removed during surgery, grown in large numbers in a laboratory, and then given back to the same person through an infusion into a vein. Before receiving lifileucel, people in the study will be given other medicines to prepare their body. These include cyclophosphamide and fludarabine phosphate, which are chemotherapy drugs that help make room for the infused cells to work better. After the lifileucel infusion, people will receive aldesleukin, a substance that helps support the immune system. People taking part in this study must have already received treatment with an anti-PD-(L)1 medicine, and if their melanoma has a specific change called a BRAF V600 mutation, they must have also been treated with a BRAF inhibitor medicine with or without a MEK inhibitor.

The purpose of this study is to see how well lifileucel works in shrinking or stopping the growth of melanoma tumors in people who have already been treated with other therapies. The study will measure how many people have their tumors shrink or disappear completely after receiving lifileucel. It will also look at how long the treatment response lasts, how long people live without their cancer getting worse, overall survival, and the safety of the treatment.

During the study, people will first have surgery to remove a tumor or part of a tumor so that the immune cells can be collected and grown in the laboratory. After the tumor is removed, people will wait while the lifileucel is being prepared. Once ready, they will receive the chemotherapy medicines cyclophosphamide and fludarabine phosphate through a vein over several days to prepare their body. Then they will receive a single infusion of lifileucel. Following this, they will receive aldesleukin through a vein to help support the infused cells. After treatment, people will be monitored regularly with scans and tests to see how their cancer responds and to check for any side effects. The study will continue to follow people for up to five years after they receive the lifileucel infusion.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Tumor removal procedure

    A surgical procedure will be performed to remove at least one tumor with an estimated minimum diameter of 1.5 cm. This tumor tissue will be used to prepare your treatment.

    It is preferred that the tumor selected for removal has not been previously treated with radiation. If it has been irradiated, the radiation must have occurred at least 3 months before the removal, and the tumor must have shown clear growth after radiation therapy.

    After this procedure, you must have at least one measurable tumor remaining that can be monitored during the study.

  2. Step 2

    Preparation period

    During this period, your tumor tissue will be processed in a laboratory to prepare lifileucel, a treatment made from cells taken from your own tumor called tumor-infiltrating lymphocytes.

    You will need to recover from the tumor removal procedure before proceeding to the next step.

    You must have recovered from all previous cancer treatment side effects to a mild level, except for nerve damage, hair loss, or skin color changes. If you have stable hormone-related conditions from previous treatments that are controlled with hormone replacement, you may continue.

  3. Step 3

    Lymphodepleting chemotherapy

    You will receive chemotherapy to prepare your body for the lifileucel infusion. This step reduces the number of certain white blood cells in your body to make room for the treatment cells.

    You will be given cyclophosphamide and fludarabine phosphate. Both medications will be administered through a vein.

    The specific doses, frequency, and duration of this chemotherapy will be determined according to the study protocol.

  4. Step 4

    Lifileucel infusion

    You will receive a single infusion of lifileucel through a vein. This infusion contains the cells that were prepared from your tumor tissue.

    The infusion will be given after the lymphodepleting chemotherapy is completed.

  5. Step 5

    Supportive treatment with aldesleukin

    Following the lifileucel infusion, you will receive aldesleukin, also known as interleukin-2. This medication helps the infused cells grow and function in your body.

    Aldesleukin will be administered through a vein or by injection.

    The specific dose, frequency, and duration will be determined according to the study protocol.

  6. Step 6

    Monitoring and follow-up assessments

    You will be monitored closely for side effects and your response to treatment. This includes regular tumor assessments using imaging scans.

    The first tumor assessment after treatment will occur at a scheduled time point.

    You are expected to receive optimal supportive care, including intensive care if needed, from the time you join the study until the first tumor assessment after treatment.

    Follow-up will continue for up to 5 years after the lifileucel infusion to evaluate the long-term effects of the treatment and monitor your disease status.

  7. Step 7

    Long-term follow-up period

    Regular assessments will continue to monitor your tumor status, overall survival, and any long-term side effects.

    These assessments will track whether your tumor shrinks, stays the same, or grows, and how long any response to treatment lasts.

    Monitoring will continue until disease progression, the start of a new cancer therapy, death, or for a maximum of 5 calendar years after the lifileucel infusion, whichever occurs first.

Who can join the trial?

21 criteria

  • You must be at least 18 years old when you sign the consent form. If you are older than 70 years, your doctor will need to discuss your participation with the study team, considering your overall health and daily activity level.
  • You must have advanced melanoma, which is a type of skin cancer that has spread, confirmed by laboratory testing. This must be Stage IIIC, IIID, or IV that cannot be removed by surgery.
  • Your cancer must have gotten worse while taking or after taking a medicine called an anti-PD-(L)1 treatment, which is a type of cancer therapy that helps your immune system fight cancer. This must have happened either during treatment for advanced melanoma or within 12 weeks after receiving this treatment to prevent cancer from coming back.
  • If your melanoma has a specific change in a gene called BRAF V600 mutation, you may have received one additional treatment with medicines called BRAF inhibitors or MEK inhibitors, which are drugs that target this gene change.
  • You must be able to care for yourself and perform light activities. Your doctor will rate this using a scale called ECOG performance status of 0 or 1, and you must be expected to live longer than 6 months.
  • You must have at least one tumor that can be removed by surgery, with a size of at least 1.5 centimeters. This tumor will be used to make your treatment. It is better if this tumor was not treated with radiation before, or if it was, the radiation must have been at least 3 months ago and the tumor must have grown since then.
  • After the tumor is removed for making your treatment, you must still have at least one tumor that can be measured to check if the treatment is working.
  • You must be able to stop taking other cancer treatments or experimental medicines before starting this study.
  • If you have any planned surgeries, they must be completed before the tumor is removed for this study, and you must be fully healed.
  • You must have recovered from side effects of previous cancer treatments to a mild level or less, except for nerve damage, hair loss, or skin color changes. If you have stable hormone problems from previous treatments that are controlled with hormone replacement, you may still participate.
  • If you had severe diarrhea or inflammation of the colon from previous cancer treatment, you must have had no symptoms for at least 6 months or had a normal colon examination.
  • If you are a man, you must agree not to donate sperm and either avoid sexual intercourse that could result in pregnancy or use a condom along with your partner using highly effective birth control.
  • If you are a woman able to become pregnant, you must use highly effective birth control and agree not to donate eggs. You must have a negative pregnancy test within 24 hours before your tumor is removed.
  • If you are a woman, you must not be pregnant or breastfeeding.
  • You must be able to understand and sign the consent form and follow the study requirements.
  • You must provide written permission for your health information to be used for this study.
  • Your blood tests must show adequate levels of white blood cells, red blood cells, and platelets. Specifically, your absolute neutrophil count, which measures infection-fighting white blood cells, must be at least 1000 per cubic millimeter; your hemoglobin, which carries oxygen in your blood, must be at least 8.0 grams per deciliter; and your platelet count, which helps blood clot, must be at least 100,000 per cubic millimeter.
  • Your liver and kidney function must be adequate. Your liver enzymes called ALT and AST must be no more than 3 times the normal upper limit, or up to 5 times if cancer has spread to your liver. Your bilirubin, a substance processed by the liver, must be no more than 2 milligrams per deciliter, or up to 3 if you have a condition called Gilbert's syndrome. Your kidney function measured by creatinine clearance must be at least 40 milliliters per minute.
  • Your heart function must be adequate, with a measurement called left ventricular ejection fraction greater than 45 percent, which shows how well your heart pumps blood. If you are 60 years or older or have heart disease history, you may need a heart stress test showing no significant problems.
  • If you have a history of smoking at least 20 pack-years, recently quit or still smoke, have chronic lung disease, have breathing problems, or had fluid drained from around your lungs in the past 3 months, you must pass a breathing test showing adequate lung function.
  • You must be willing to receive the best supportive care available, including intensive care if needed, from the time you join the study until your first tumor assessment after treatment.

Who cannot join the trial?

4 criteria

  • The source data does not provide specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
  • Exclusion criteria are conditions or factors that would prevent someone from joining a study to ensure patient safety and reliable results
  • Without detailed exclusion information in the provided data, it is not possible to list specific reasons that would make a patient ineligible for this trial
  • Typical exclusion criteria in cancer trials may include certain other medical conditions, previous treatments, laboratory test results, or organ function levels, but these specific details are not available in the current data
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Investigated drugs

Lifileucel is a treatment made from your own immune cells called tumor-infiltrating lymphocytes, or TIL for short. These are special white blood cells that are naturally found in your tumor and have the ability to recognize and fight cancer. To make this treatment, doctors will remove a small piece of your tumor and send it to a laboratory. There, the TIL cells are separated from the tumor tissue and grown in large numbers over several weeks. Once enough cells have been grown, they are given back to you through an infusion into your vein. The goal is to boost your immune system's ability to attack and destroy melanoma cancer cells throughout your body.

What is already known about the treatment

Lifileucel – Lifileucel is an experimental cancer treatment made from a patient's own tumor-infiltrating lymphocytes, which are special immune cells taken from the patient's tumor tissue, grown in large numbers in a laboratory, and then given back to the patient through an intravenous infusion. This therapy is currently being studied in clinical trials for people with advanced melanoma (a serious type of skin cancer) who have already received other treatments that did not work well enough. Lifileucel works by using the body's own immune system to recognize and attack cancer cells, as these lymphocytes are naturally designed to fight the tumor but are boosted in number to make them more effective. This medication belongs to a class of treatments called cell-based immunotherapies, which harness the power of the immune system to fight cancer.

Investigated diseases

Advanced Melanoma – Advanced melanoma is a serious form of skin cancer that has spread beyond its original location to other parts of the body. This disease occurs when pigment-producing cells called melanocytes grow uncontrollably and become cancerous. In its advanced stage, the cancer has typically spread to distant organs or lymph nodes, making it more difficult to manage. The disease can progress from earlier stages of melanoma or may be detected when it has already spread. Advanced melanoma may involve genetic mutations, including changes in the BRAF V600 gene, which affects how the cancer cells grow and respond to certain therapies. The condition continues to progress if the cancer cells keep multiplying and spreading to additional areas of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522054-40-00Protocol codeIOV-MEL-202Estimated enrolment100 patientsSponsorIovance Biotherapeutics Inc.

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