Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony czerniak w stadium IIIc, IIId lub IV, którego nie można usunąć operacyjnie ani który jest rozsiany.
- •Ogólny stan zdrowia pacjenta oceniany jako dobry (ECOG 0-1) i przewidywana długość życia powyżej 6 miesięcy.
- •Posiadanie przynajmniej jednej zmiany, z której można pobrać komórki do przygotowania lifileucelu.
- •Posiadanie co najmniej jednej mierzalnej zmiany chorobowej po operacji usunięcia guza.
- •Dobra czynność narządów (np. nerek, wątroby).
✗ Disqualifies
- •Czerniak pochodzenia ocznego.
- •Aktywne przerzuty do mózgu, które nie były leczone.
- •Przyjmowanie więcej niż jednego wcześniejszego leczenia.
- •Wcześniejsze leczenie choroby rozsianej.
- •Posiadanie innych aktywnych, poważnych chorób, które mogą zwiększać ryzyko udziału w badaniu.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- September 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (82)
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, United States
City of Hope
Duarte, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
California Pacific Medical Center
San Francisco, United States
University of Colorado Cancer Center
Aurora, United States
Orlando Health Cancer Institute
Orlando, United States
University of Illinois Hospital & Health Sciences System
Chicago, United States
University of Kansas
Kansas City, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, United States
National Cancer Institute
Bethesda, United States
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, United States
Henry Ford Health
Detroit, United States
University of Minnesota
Minneapolis, United States
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
Lebanon, United States
MD Anderson Cancer Center at Cooper
Camden, United States
Oncology Hematology Care
Cincinnati, United States
Ohio State University
Columbus, United States
St. Luke's Cancer Center - Anderson
Easton, United States
Allegheny Health Network
Pittsburgh, United States
Baptist Cancer Center
Bartlett, United States
SCRI Oncology Partners
Nashville, United States
Intermountain Health
Salt Lake City, United States
Virginia Commonwealth University
Richmond, United States
Swedish Cancer Institute
Edmonds, United States
Greenslopes Private Hospital
Greenslopes, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
Flinders Medical Centre
Bedford Park, Australia
Westmead Hospital
Westmead, Australia
Universitair Ziekenhuis Brussel - Oncologisch Centrum
Jette, Belgium
Centre hospitalier de l'Université de Montréal
Montreal, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Helsinki University Hospital Comprehensive Cancer Center
Helsinki, Finland
Institut Paoli Calmettes
Marseille, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, France
Hopital Saint Louis
Paris, France
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Germany
Klinikum Rechts der Isar der Technischen Universität München
Munich, Germany
Hadassah Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Istituto Romagnolo per lo Studio dei Tumori
Meldola, Italy
Centro di Riferimento Oncologico IRCCS
Aviano, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Naples, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Istituto Europeo Di Oncologia
Milan, Italy
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Nederlands Kanker Instituut
Amsterdam, Netherlands
National Cancer Centre Singapore
Singapore, Singapore
Bundang Medical Center - CHA University
Seongnam-si, South Korea
Samsung Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Spain
Institut Català d'Oncologia (ICO)
Barcelona, Spain
HM Centro Integral Oncologico Clara Campal
Madrid, Spain
Instituto Oncologico Rosell
Barcelona, Spain
Hospital Universitari Vall dHebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Universitario Madrid Sanchinarro - CIOCC
Madrid, Spain
Hospital Universitario Quirónsalud Madrid
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Clínica Universitaria de Navarra
Pamplona, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, Switzerland
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Royal Marsden Hospital
Chelsea, United Kingdom
Beaston West of Scotland Canter Centre
Glasgow, United Kingdom
Guy's Hospital
London, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom
Trial contact
Iovance Biotherapeutics https://www.tilvance-301.com
Iovance Biotherapeutics Study Team
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/25/2026.
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