NCT05727904From ClinicalTrials.govRecruiting

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma

Metastatic Melanoma
Unresectable Melanoma
Melanoma

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Iovance Biotherapeutics, Inc.
Enrolment target: 670
Started: 30 March 2023
Main results due: 1 March 2028
Study sites: 82
Registry updated: 24 September 2026

Can you take part?

Ages 18 years to 70 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
2. In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \> 6 months.
3. Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
4. Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
5. Participants must have adequate organ function.
6. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
7. Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

Exclusion Criteria:

1. Participant has melanoma of uveal/ocular origin.
2. Participant has symptomatic untreated brain metastases.
3. Participant received more than 1 prior line of therapy.
4. Participant received prior therapy for metastatic disease
5. Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
6. 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.
7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
8. 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.)
9. Participant has a history of allogeneic cell or organ transplant.

Other protocol defined inclusion/exclusion criteria could apply.

What this study is about

In the sponsor’s own words, from the registry.

This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.

Study sites(82)

University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, United States
Recruiting
City of Hope
Duarte, California, United States
Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Recruiting
California Pacific Medical Center
San Francisco, California, United States
Withdrawn
University of Colorado Cancer Center
Aurora, Colorado, United States
Recruiting
Orlando Health Cancer Institute
Orlando, Florida, United States
Recruiting
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States
Withdrawn
University of Kansas
Kansas City, Kansas, United States
Withdrawn
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
Withdrawn
National Cancer Institute
Bethesda, Maryland, United States
Recruiting
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan, United States
Withdrawn
Henry Ford Health
Detroit, Michigan, United States
Withdrawn
University of Minnesota
Minneapolis, Minnesota, United States
Recruiting
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Recruiting
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States
Recruiting
Oncology Hematology Care
Cincinnati, Ohio, United States
Recruiting
Ohio State University
Columbus, Ohio, United States
Recruiting
St. Luke's Cancer Center - Anderson
Easton, Pennsylvania, United States
Withdrawn
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Recruiting
Baptist Cancer Center
Bartlett, Tennessee, United States
Recruiting
SCRI Oncology Partners
Nashville, Tennessee, United States
Recruiting
Intermountain Health
Salt Lake City, Utah, United States
Recruiting
Virginia Commonwealth University
Richmond, Virginia, United States
Withdrawn
Swedish Cancer Institute
Edmonds, Washington, United States
Recruiting
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Recruiting
Flinders Medical Centre
Bedford Park, Australia
Recruiting
Westmead Hospital
Westmead, Australia
Recruiting
Universitair Ziekenhuis Brussel - Oncologisch Centrum
Jette, Belgium
Recruiting
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Recruiting
Princess Margaret Cancer Centre
Toronto, Canada
Recruiting
Helsinki University Hospital Comprehensive Cancer Center
Helsinki, Finland, Finland
Recruiting
Institut Paoli Calmettes
Marseille, France
Recruiting
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, France
Recruiting
Hopital Saint Louis
Paris, France
Recruiting
Charité - Universitätsmedizin Berlin
Berlin, Germany, Germany
Recruiting
Universitätsklinikum Würzburg
Würzburg, Germany, Germany
Recruiting
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Germany
Recruiting
Klinikum Rechts der Isar der Technischen Universität München
Munich, Germany
Recruiting
Hadassah Medical Center
Jerusalem, Israel
Recruiting
Sheba Medical Center
Ramat Gan, Israel
Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Withdrawn
Istituto Romagnolo per lo Studio dei Tumori
Meldola, Forlì-Cesena, Italy
Recruiting
Centro di Riferimento Oncologico IRCCS
Aviano, Friuli Venezia Giulia, Italy
Recruiting
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Naples, Napoli, Italy
Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Recruiting
Istituto Europeo Di Oncologia
Milan, Italy
Withdrawn
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Recruiting
Nederlands Kanker Instituut
Amsterdam, Netherlands
Recruiting
National Cancer Centre Singapore
Singapore, Singapore, Singapore
Recruiting
Bundang Medical Center - CHA University
Seongnam-si, Gyeonggi-do, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea, South Korea
Recruiting
Korea University Anam Hospital
Seoul, South Korea
Recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga, Spain
Recruiting

Showing 60 of 82 sites — filter to narrow it down. 71 of the 82 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05727904. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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