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Immune cells from your own tumor could fight advanced melanoma

NCT ID NCT07288203

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental therapy called lifileucel for people with advanced melanoma that has spread or cannot be removed by surgery and has worsened after standard treatments. About 100 adults will receive their own tumor-fighting immune cells (TILs) grown in a lab. The main goal is to see if the treatment shrinks tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma. * The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of \> 6 months. * The participant must have experienced radiographic disease progression on: 1 prior line of an anti-PD-(L)1 treatment (as a monotherapy or as part of a combination) for advanced melanoma and/or during or within ≤ 12 weeks after adjuvant anti-PD-(L)1 treatment (as a monotherapy or as part of a combination). Participants who have BRAF V600 mutation positive melanoma may have received 1 additional prior line of treatment with a BRAF inhibitor ± a MEK inhibitor. * Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation. * Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection. * Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor. * Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control. * Participants must have adequate organ function. * Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post-treatment tumor assessment. Exclusion Criteria: * Participant has melanoma of uveal/ocular origin. * Participant has symptomatic untreated brain metastases. * Participant has active uveitis that requires active treatment. * Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems. * Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS). * Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.) * Participant has a history of allogeneic cell or organ transplant. * Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. Other protocol defined inclusion/exclusion criteria could apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centre Hospitalier de l'Universite de Montreal

    Montral, Quebec, Canada, H2X 0A9, Canada

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canada, M5G 2M9, Canada

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

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