Supercharged immune cells take on advanced melanoma in major new trial

NCT ID NCT05727904

Recruiting now Disease control Sponsor: Iovance Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial is testing whether a powerful combination of two treatments works better than standard immunotherapy alone for people with advanced melanoma that has not been treated yet. The experimental approach uses lifileucel, a personalized therapy made from a patient's own tumor-fighting immune cells, given together with the immunotherapy drug pembrolizumab. About 670 participants will be randomly assigned to receive either the combination or pembrolizumab alone, with the goal of seeing which group has better tumor shrinkage and longer time without cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Lifileucel (a personalized cell therapy made from a patient's own tumor-fighting immune cells) plus pembrolizumab (an immunotherapy drug)
What this could lead to: If successful, this combination could offer a more effective first-line treatment for advanced melanoma, potentially shrinking tumors and delaying progression better than standard immunotherapy alone.
What could go wrong: This is an early Phase 3 trial, so results are not yet proven. The cell therapy requires surgery and a complex manufacturing process, and side effects from lymphodepletion and IL-2 can be severe. Not all patients may benefit.

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

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma skin neoplasm

As listed by the trial registrant

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

MELANOMA METASTATIC MELANOMA UNRESECTABLE MELANOMA

Contacts and locations

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Study contacts

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Locations

Allegheny Health Network
RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
Azienda Ospedaliera Universitaria Senese
RECRUITING

Siena, Italy
Azienda Ospedaliero Universitaria Pisana
RECRUITING

Pisa, Tuscany, 56100, Italy
Baptist Cancer Center
RECRUITING

Bartlett, Tennessee, 37920, United States
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
WITHDRAWN

Detroit, Michigan, 48201, United States
Beaston West of Scotland Canter Centre
RECRUITING

Glasgow, G120YN, United Kingdom
Bundang Medical Center - CHA University
RECRUITING

Seongnam-si, Gyeonggi-do, South Korea
California Pacific Medical Center
RECRUITING

San Francisco, California, 94107, United States
Centre Hospitalier Universitaire Vaudois Lausanne
RECRUITING

Lausanne, 1011, Switzerland
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
RECRUITING

Nantes, 44093, France
Centre hospitalier de l'Université de Montréal
RECRUITING

Montreal, Quebec, H2L 4M1, Canada
Centro di Riferimento Oncologico IRCCS
RECRUITING

Aviano, Friuli Venezia Giulia, 33081, Italy
Charité - Universitätsmedizin Berlin
RECRUITING

Berlin, Germany, 13353, Germany
City of Hope
RECRUITING

Duarte, California, 91010, United States
Clínica Universitaria de Navarra
RECRUITING

Pamplona, 31008, Spain
Consorcio Hospital General Universitario de Valencia
RECRUITING

Valencia, 46014, Spain
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
RECRUITING

Lebanon, New Hampshire, 03756, United States
Fiona Stanley Hospital
RECRUITING

Murdoch, Western Australia, 6150, Australia
Flinders Medical Centre
RECRUITING

Bedford Park, 5042, Australia
Freeman Hospital
RECRUITING

Newcastle upon Tyne, England, NE7 7DN, United Kingdom
Greenslopes Private Hospital
RECRUITING

Greenslopes, Queensland, 4120, Australia
Guy's Hospital
RECRUITING

London, SE1 9RT, United Kingdom
HM Centro Integral Oncologico Clara Campal
RECRUITING

Madrid, Spain, 28050, Spain
Hadassah Medical Center
RECRUITING

Jerusalem, Israel
Helsinki University Hospital Comprehensive Cancer Center
RECRUITING

Helsinki, Finland, 290, Finland
Henry Ford Health
RECRUITING

Detroit, Michigan, 48202, United States
Hopital Saint Louis
RECRUITING

Paris, 75475, France
Hospital 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Clinic de Barcelona
RECRUITING

Barcelona, 8036, Spain
Hospital General Universitario Gregorio Maranon
RECRUITING

Madrid, 28007, Spain
Hospital Regional Universitario de Malaga - Hospital General
RECRUITING

Málaga, Málaga, 29016, Spain
Hospital Universitari Vall dHebron
WITHDRAWN

Barcelona, 08035, Spain
Hospital Universitario Madrid Sanchinarro - CIOCC
RECRUITING

Madrid, 28050, Spain
Hospital Universitario Marques de Valdecilla
RECRUITING

Santander, Cantabria, 39008, Spain
Hospital Universitario Quirónsalud Madrid
RECRUITING

Madrid, 28223, Spain
Hospital Universitario Ramon y Cajal
RECRUITING

Madrid, Spain
Hospital Universitario Virgen Macarena
RECRUITING

Seville, 41009, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
RECRUITING

Barcelona, 8908, Spain
Institut Català d'Oncologia (ICO)
RECRUITING

Barcelona, Spain, 8908, Spain
Institut Paoli Calmettes
RECRUITING

Marseille, 13009, France
Instituto Oncologico Rosell
RECRUITING

Barcelona, 08028, Spain
Intermountain Health
RECRUITING

Salt Lake City, Utah, 84112, United States
Istituto Europeo Di Oncologia
WITHDRAWN

Milan, 20139, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
RECRUITING

Naples, Napoli, 80131, Italy
Istituto Romagnolo per lo Studio dei Tumori
RECRUITING

Meldola, Forlì-Cesena, 47014, Italy
Klinikum Rechts der Isar der Technischen Universität München
RECRUITING

Munich, 81675, Germany
Korea University Anam Hospital
RECRUITING

Seoul, 2841, South Korea
MD Anderson Cancer Center at Cooper
RECRUITING

Camden, New Jersey, 08103, United States
National Cancer Centre Singapore
RECRUITING

Singapore, Singapore, 168582, Singapore
National Cancer Institute
RECRUITING

Bethesda, Maryland, 20814, United States
Nederlands Kanker Instituut
RECRUITING

Amsterdam, 1066 CX, Netherlands
Ohio State University
RECRUITING

Columbus, Ohio, 43201, United States
Oncology Hematology Care
RECRUITING

Cincinnati, Ohio, 45226, United States
Orlando Health Cancer Institute
RECRUITING

Orlando, Florida, 32806, United States
Peter MacCallum Cancer Centre
RECRUITING

Melbourne, Victoria, 3000, Australia
Princess Margaret Cancer Centre
RECRUITING

Toronto, M5G, Canada
Queen Elizabeth Hospital Birmingham
RECRUITING

Birmingham, England, B15 2GW, United Kingdom
Royal Marsden Hospital
RECRUITING

Chelsea, London, SW3 6JJ, United Kingdom
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
Sahlgrenska Universitetssjukhuset
RECRUITING

Gothenburg, Västra Götaland County, SE-41346, Sweden
Samsung Medical Center
RECRUITING

Seoul, South Korea, 135-890, South Korea
Sarah Cannon Research Institute UK
RECRUITING

London, W1G 6AD, United Kingdom
Seoul National University Hospital
RECRUITING

Seoul, 3080, South Korea
Severance Hospital, Yonsei University Health System
RECRUITING

Seoul, 3722, South Korea
Sheba Medical Center
RECRUITING

Ramat Gan, 52621, Israel
St. Luke's Cancer Center - Anderson
WITHDRAWN

Easton, Pennsylvania, 18045, United States
Swedish Cancer Institute
RECRUITING

Edmonds, Washington, 98026, United States
Tel Aviv Sourasky Medical Center
RECRUITING

Tel Aviv, 6423906, Israel
USC Norris Comprehensive Cancer Center
RECRUITING

Los Angeles, California, 90007, United States
Universitair Ziekenhuis Brussel - Oncologisch Centrum
RECRUITING

Jette, Belgium
University of Alabama at Birmingham: The Kirklin Clinic
RECRUITING

Birmingham, Alabama, 35233, United States
University of Colorado Cancer Center
RECRUITING

Aurora, Colorado, 80045, United States
University of Illinois Hospital & Health Sciences System
WITHDRAWN

Chicago, Illinois, 60612, United States
University of Kansas
WITHDRAWN

Kansas City, Kansas, 66205, United States
University of Louisville - James Graham Brown Cancer Center
WITHDRAWN

Louisville, Kentucky, 40202, United States
University of Minnesota
RECRUITING

Minneapolis, Minnesota, 55455, United States
Universitätsklinikum Carl Gustav Carus
RECRUITING

Dresden, 1307, Germany
Universitätsklinikum Hamburg-Eppendorf
RECRUITING

Hamburg, 20251, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
RECRUITING

Lübeck, 23562, Germany
Virginia Commonwealth University
WITHDRAWN

Richmond, Virginia, 23298, United States
Westmead Hospital
RECRUITING

Westmead, NSW 2145, Australia

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