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Study on the Effectiveness and Safety of Lifileucel and Pembrolizumab for Patients with Untreated, Unresectable, or Metastatic 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 clinical trial is focused on studying the effectiveness and safety of a treatment for melanoma, a type of skin cancer that can spread to other parts of the body. The study will compare two treatments: one group will receive a combination of lifileucel and pembrolizumab, while the other group will receive only pembrolizumab. Lifileucel is a type of cell therapy that uses a patient's own immune cells, known as tumor-infiltrating lymphocytes, to help fight cancer. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system detect and attack cancer cells.

The purpose of the study is to determine if the combination of lifileucel and pembrolizumab is more effective than pembrolizumab alone in treating patients with melanoma that cannot be removed by surgery or has spread to other parts of the body. Participants in the study will be randomly assigned to one of the two treatment groups. The study will involve regular visits to the clinic for treatment and monitoring, which will include infusions of the medications and assessments of the cancer's response to the treatment.

Throughout the study, participants will receive supportive care to manage any side effects and ensure their well-being. The study aims to provide valuable information on whether the combination treatment can improve outcomes for patients with melanoma. The trial will continue until enough data is collected to make a clear comparison between the two treatment options.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Upon joining the study, the participant will begin the initial treatment phase. This phase involves the administration of pembrolizumab through an infusion. Pembrolizumab is a medication used to help the immune system fight cancer cells.

    The infusion of pembrolizumab will be given at a dosage of 25 mg/mL. The frequency and duration of this treatment will be determined by the study protocol and the participant's response to the medication.

  2. Step 2

    Combination treatment phase

    In this phase, participants may receive a combination of lifileucel and pembrolizumab. Lifileucel is a type of treatment that uses the participant's own immune cells to target cancer.

    The combination treatment aims to enhance the effectiveness of pembrolizumab. The administration of lifileucel will be through an infusion, and the schedule will be based on the study's guidelines.

  3. Step 3

    Supportive care phase

    Throughout the trial, participants will receive supportive care to manage any side effects and ensure overall well-being. This may include medications like mesna to protect the bladder from harmful effects of certain treatments.

    Supportive care is tailored to each participant's needs and may involve additional medications or therapies as required.

  4. Step 4

    Monitoring and assessment phase

    Participants will undergo regular monitoring and assessments to evaluate the effectiveness of the treatment. This includes imaging tests and other evaluations to track the progress of the melanoma.

    The assessments will be conducted by a blinded independent review committee using specific criteria to ensure accurate and unbiased results.

  5. Step 5

    End of treatment phase

    At the conclusion of the treatment period, participants will have a final assessment to determine the overall outcome of the trial.

    The results will help in understanding the efficacy and safety of the combination treatment compared to pembrolizumab alone.

Who can join the trial?

15 criteria

  • The participant must be between 18 and 70 years old.
  • The participant must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma. This means the melanoma cannot be removed by surgery or has spread to other parts of the body.
  • The participant must have a good general health status, as assessed by a doctor, with an ECOG performance status of 0 or 1. This is a scale used to assess how a disease affects a patient's daily living abilities.
  • The participant must have at least one resectable lesion with a minimum size of 1.5 cm. A resectable lesion is a tumor that can be removed by surgery.
  • The participant must have at least one measurable lesion, which is a tumor that can be measured in size.
  • If the participant has any planned surgeries, they must be completed at least 14 days before the tumor is removed, and the participant must have healed from the surgery.
  • The participant must have recovered from any side effects of previous cancer treatments to a mild level.
  • Male participants must agree to not donate sperm and either abstain from heterosexual intercourse or use contraception during the study and for 12 months after the last dose. Female participants must not be pregnant or breastfeeding and must use effective contraception during the study and for 12 months after the last dose.
  • The participant must be able to give informed consent, which means they understand the study and agree to participate.
  • The participant must provide written permission for the use and sharing of their health information.
  • The participant must have certain blood test results within normal ranges, including ANC (a type of white blood cell count), hemoglobin (a protein in red blood cells), and platelet count (cells that help with blood clotting).
  • The participant must have normal organ function based on specific lab tests, including liver enzymes (ALT and AST), bilirubin (a substance made by the liver), and creatinine clearance (a measure of kidney function).
  • The participant must have a left ventricular ejection fraction (LVEF) greater than 45% and be NYHA Class 1, which means they have no symptoms of heart failure.
  • If the participant has a history of smoking, COPD (a lung disease), or other breathing issues, they must meet certain lung function criteria.
  • The participant must be willing to receive the best possible supportive care, including intensive care if needed, from the start of the study until the first tumor assessment after treatment.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than melanoma cannot participate. Melanoma is a type of skin cancer.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have had certain treatments or medications that might affect the study results cannot participate.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who have an active infection or illness that could affect the study cannot participate.
  • Patients who have a history of certain mental health conditions that might interfere with the study cannot participate.
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Investigated drugs

  • Lifileucel

    is a type of therapy that uses your own immune cells to fight cancer. These cells, known as tumor-infiltrating lymphocytes (TIL), are taken from your tumor, grown in large numbers in a lab, and then given back to you to help your body attack the cancer.

  • Pembrolizumab

    is a medication that helps your immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing your body to better target and destroy them.

What is already known about the treatment

  • Lifileucel

    This medication is administered through infusion and is used in combination with pembrolizumab for treating melanoma. It is currently being studied in clinical trials to evaluate its effectiveness and safety. Lifileucel is primarily indicated for patients with untreated, unresectable, or metastatic melanoma. It works by using the patient's own tumor-infiltrating lymphocytes to target and destroy cancer cells. Lifileucel is classified as an immunotherapy agent.

  • Pembrolizumab

    This medication is administered via intravenous infusion and is used as a monotherapy or in combination with other treatments for melanoma. It is well-established in medical literature and is approved for use in various cancers, including melanoma. Pembrolizumab is indicated for patients with untreated, unresectable, or metastatic melanoma. It functions by blocking the PD-1 pathway, enhancing the immune system's ability to attack cancer cells. Pembrolizumab is classified as a checkpoint inhibitor.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It often appears as a new mole or a change in an existing mole, typically with irregular borders and multiple colors. Melanoma can occur anywhere on the body but is most common on areas exposed to the sun, such as the back, legs, arms, and face. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. Early detection is crucial, as melanoma can be more effectively managed when identified in its initial stages. Regular skin checks and awareness of changes in moles or skin appearance are important for early identification.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-503140-41-00Protocol codeIOV-MEL-301Estimated enrolment810 patientsSponsorIovance Biotherapeutics Inc.

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