Active not recruitingPHASE2INTERVENTIONAL

A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma

This is a study for adults aged 18 to 70 with advanced melanoma, a serious form of skin cancer that has spread or can't be removed by surgery. The study is investigating a new treatment called lifileucel. This treatment uses a patient's own immune cells (called tumor-infiltrating lymphocytes, or TILs) to fight the cancer. You might be able to join if your melanoma has still progressed even after you've had at least one other type of treatment. For example, if you've already received medicines that boost your immune system (like anti-PD-1 or anti-PD-L1 therapies) and your cancer has continued to grow, this study might be an option. Researchers want to see how safe and effective lifileucel is in this group of patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Iovance Biotherapeutics, Inc.

Enrolment target

100

Start

28 Nov 2025

Estimated completion

01 Dec 2033

Melanoma (Skin Cancer)Unresectable Melanoma Metastatic Melanoma

What is this study about?

This study is looking into a new treatment called lifileucel for people who have advanced melanoma. Advanced melanoma means the skin cancer has spread to other parts of the body or cannot be completely removed by surgery. For many people, melanoma can be a very serious condition, and finding new and effective treatments is really important.

Lifileucel is a type of treatment that uses your body's own immune system to fight the cancer. It involves taking some of your immune cells, specifically a type called 'tumour-infiltrating lymphocytes' (TILs), from your tumour. These cells are then grown in a lab to create many more of them. Once there are enough, these specially prepared cells are put back into your body to help your immune system attack the cancer cells more effectively. This is a phase 2 study, which means researchers are checking to see how well it works and if it's safe.

The main goal of this study is to see if lifileucel can help shrink or control advanced melanoma in patients who have already tried other treatments that didn't stop the cancer from growing. Specifically, it's for people whose cancer has progressed after having types of immunotherapy or, for some, after trying other targeted treatments if their cancer has a specific gene change (called a BRAF V600 mutation). The study will help doctors learn more about this promising new way to fight melanoma.

Key takeaways

This study is testing a new treatment called lifileucel for advanced melanoma.
It's for adults aged 18-70 whose melanoma has progressed despite previous treatments.
Lifileucel uses your body's own immune cells to fight the cancer.
The study aims to see if lifileucel is safe and effective.
You'll need regular check-ups and monitoring if you join.
It's important to discuss all benefits and risks with your doctor.

Who may be eligible?

This study is looking for adults aged between 18 and 70 years old who have advanced melanoma.

You might be able to take part if you have melanoma that has spread or can't be removed by surgery, and if your cancer has continued to grow even after you've had at least one previous treatment. This often includes treatments that help your immune system fight cancer. If you have a specific type of melanoma with a BRAF V600 gene change, you might also have had other targeted treatments.

However, you won't be able to join if your melanoma started in your eye, or if you have serious untreated brain tumours. Other reasons you might not be suitable include having certain active medical problems, like severe heart or lung conditions, or significant infections, as these could make participation risky. Your medical team will carefully check all your health details to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you have advanced melanoma that has spread or can't be removed by surgery?
Has your melanoma continued to grow after at least one previous treatment (like immunotherapy)?
Do you have at least one tumour that can be safely removed for the treatment?
Are you generally well and able to perform daily activities without much difficulty (ECOG 0 or 1)?
Do you have good overall organ health?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process will involve several steps. First, doctors will need to take a small piece of your tumour (a biopsy) to get some of your immune cells. These cells will then be sent to a lab to be grown into many more cells – this can take several weeks.

Before you receive the lifileucel treatment, you will likely need to have a short course of chemotherapy to prepare your body. Then, you will receive the lifileucel cells through an infusion, similar to a drip. After the treatment, you will need close monitoring by doctors and nurses for a period of time. You will have regular follow-up appointments, scans, and blood tests to check how you are doing, how the treatment is affecting your cancer, and to look for any side effects. The total duration of your participation, including follow-up, will be discussed by the study team, but it will involve ongoing check-ups over an extended period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that lifileucel might help to control or shrink your advanced melanoma, especially if other treatments haven't worked well for you. However, there's no guarantee that it will work for everyone. Potential risks include side effects from the chemotherapy given before the lifileucel, as well as side effects directly from the lifileucel treatment itself. These could range from mild to serious, and the study team will explain all known risks to you. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Sarah Cannon Research Institute
Verified postcode
Nashville, United States
Greenslopes Private Hospital
Verified postcode
Greenslopes, Australia
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada
Centre Hospitalier de l'Universite de Montreal
Unverified
Montral, Canada
Royal Marsden Hospital
Verified postcode
London, United Kingdom

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that starts in the cells that give your skin its colour. Advanced melanoma means the cancer has spread to other parts of your body.

What is 'advanced' melanoma?

Advanced melanoma means the cancer has spread beyond the original site or cannot be removed by surgery. It is a more serious stage of the disease.

What is lifileucel?

Lifileucel is a new treatment that uses your own immune cells, grown in a lab, to help your body fight the cancer.

What does a 'Phase 2' study mean?

A Phase 2 study is a stage of clinical research where doctors test a new treatment on a larger group of people to see how well it works and to further evaluate its safety.

Can I still have treatment if I leave the study?

Yes, you can leave the study at any time, for any reason. Your decision will not affect the standard of care you receive from your doctors.