Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma

This study is testing a new treatment called lifileucel, which uses a person's own immune cells to fight advanced melanoma. This is for people whose melanoma has already been treated with other methods. The study is in an early stage (Phase 2), meaning researchers are mainly trying to find out how effective the treatment is at shrinking the cancer and if it's safe. They will track participants for up to five years after the treatment to see how the cancer responds and to monitor for any side effects. The goal is to see if this new approach can help control the cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Iovance Biotherapeutics Inc.

Enrolment target

Start

26 Nov 2025

Previously treated advanced melanoma

What is this study about?

This study is about a new way to treat advanced melanoma, which is a serious type of skin cancer that has spread. The treatment being tested is called lifileucel. It works by using your body's own immune cells, specifically a type called 'tumor-infiltrating lymphocytes' or TILs. These are special white blood cells that have already found their way into the tumour and are trying to fight it.

In this study, doctors will take some of your TILs, grow many more of them in a lab, and then put them back into your body. The idea is that these increased numbers of TILs will then be better able to attack and destroy the cancer cells. This is an 'open-label' study, which means both you and your doctors will know which treatment you are receiving.

This is a Phase 2 study, which is an important step in developing new medicines. It means researchers are looking closely at how well the treatment shrinks tumours and how safe it is. They want to see what percentage of people respond to the treatment and how long that response lasts. They will also be monitoring your health for up to five years after you receive the lifileucel treatment.

Key takeaways

This study is testing a new, personalised immune cell therapy (lifileucel) for advanced melanoma.
It's for people whose melanoma has been treated before but needs further options.
The treatment involves taking your own immune cells, growing them, and putting them back.
It's a Phase 2 study, focusing on how well the treatment works and its safety.
Participants will be monitored for several years after treatment.
You will know if you are receiving the active study treatment.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

A key requirement is that you must have advanced melanoma that has already been treated with other methods. This study is specifically for people whose cancer has not responded well enough to previous treatments, or whose cancer has returned after earlier treatments.

The research team will review your complete medical history and current health to determine if this study is the right fit for you. There might be other specific health conditions or medications that would make you unsuitable for the study, which the doctors will discuss with 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 18 years old or older?
Have you been diagnosed with advanced melanoma?
Has your melanoma been treated before with other therapies?
Are you able to attend regular hospital appointments for tests and follow-up?
Are you willing to undergo the required treatment steps, including infusions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo a series of tests to make sure you are suitable. Once approved, the treatment involves several steps. Doctors will first take a small sample of your tumour to get your immune cells (TILs).

While your TILs are being grown in the lab, you will receive some treatments to prepare your body, which include medications like cyclophosphamide and fludarabine. These are given to make space for the new TILs to work effectively. After this, you will receive the lifileucel treatment as an infusion, similar to a drip.

Following the treatment, you will have regular visits to the hospital for check-ups and scans. These visits will help the doctors monitor how well the treatment is working, check for any side effects, and keep track of your overall health. These follow-up appointments could continue for up to five years to ensure they gather detailed information about the long-term effects of the treatment.

Potential risks and benefits

Taking part in this study may offer potential benefits, as you would be among the first to receive a new, experimental treatment that might help control your advanced melanoma when other treatments haven't worked. However, there's no guarantee the treatment will work for everyone, and it's possible you might not see any improvement. As with all medical treatments, there are potential risks and side effects from the medications given, including lifileucel, cyclophosphamide, and fludarabine. The research team will discuss all known potential side effects with you in detail. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (4)

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

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Unverified
France
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Unverified
Italy
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Unverified
Germany
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Unverified
Spain

Common questions

What is advanced melanoma?

Advanced melanoma is a type of skin cancer that has grown and spread to other parts of your body, even after initial treatments.

What are 'immune cells' and how do they fight cancer?

Immune cells are part of your body's defence system. They can recognise and destroy cells that are unhealthy, like cancer cells. This treatment boosts their ability to do that.

Will I know if I'm getting the active treatment?

Yes, this is an 'open-label' study, meaning both you and your medical team will know that you are receiving the lifileucel treatment.

How long will I be involved in the study?

Your involvement could last for up to five years, including the treatment period and follow-up appointments to monitor your health and the treatment's effects.

What does a 'Phase 2' study mean?

A Phase 2 study is an early stage of research where doctors are mainly focused on finding out if a new treatment works and if it's safe, and what the best dose might be.