Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Start Date
3/30/2023
Completion Date
3/1/2030
Summary
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.
Detailed Description
The study will enroll participants with unresectable or metastatic melanoma (Stage IIIC, IIID, or IV per the American Joint Committee on Cancer \[AJCC\] staging system) who have had no prior therapy for metastatic disease. Previous adjuvant/neoadjuvant therapy with a single line of protooncogene B-Raf (BRAF) inhibitor with or without a mitogen-activated protein kinase (MEK) inhibitor, PD-1 inhibitor, or cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\] inhibitor is allowed, provided such treatment was completed ≥6 months before progression to metastatic disease.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
Lifileucel plus Pembrolizumab
Pembrolizumab with Optional Crossover Period
Conditions
Locations
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama 35233
United States
City of Hope
Duarte, California 91010
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90007
United States
California Pacific Medical Center
San Francisco, California 94107
United States
University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Orlando Health Cancer Institute
Orlando, Florida 32806
United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois 60612
United States
University of Kansas
Kansas City, Kansas 66205
United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky 40202
United States
National Cancer Institute
Bethesda, Maryland 20814
United States
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan 48201
United States
Henry Ford Health
Detroit, Michigan 48202
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
Lebanon, New Hampshire 03756
United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey 08103
United States
Oncology Hematology Care
Cincinnati, Ohio 45226
United States
Ohio State University
Columbus, Ohio 43201
United States
St. Luke's Cancer Center - Anderson
Easton, Pennsylvania 18045
United States
Allegheny Health Network
Pittsburgh, Pennsylvania 15224
United States
Baptist Cancer Center
Bartlett, Tennessee 37920
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Intermountain Health
Salt Lake City, Utah 84112
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Swedish Cancer Institute
Edmonds, Washington 98026
United States
Greenslopes Private Hospital
Greenslopes, Queensland 4120
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Fiona Stanley Hospital
Murdoch, Western Australia 6150
Australia
Flinders Medical Centre
Bedford Park, 5042
Australia
Westmead Hospital
Westmead, NSW 2145
Australia
Universitair Ziekenhuis Brussel - Oncologisch Centrum
Jette,
Belgium
Centre hospitalier de l'Université de Montréal
Montreal, Quebec H2L 4M1
Canada
Princess Margaret Cancer Centre
Toronto, M5G
Canada
Helsinki University Hospital Comprehensive Cancer Center
Helsinki, Finland 290
Finland
Institut Paoli Calmettes
Marseille, 13009
France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, 44093
France
Hopital Saint Louis
Paris, 75475
France
Charité - Universitätsmedizin Berlin
Berlin, Germany 13353
Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 1307
Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, 23562
Germany
Klinikum Rechts der Isar der Technischen Universität München
Munich, 81675
Germany
Hadassah Medical Center
Jerusalem,
Israel
Sheba Medical Center
Ramat Gan, 52621
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Israel
Istituto Romagnolo per lo Studio dei Tumori
Meldola, Forlì-Cesena 47014
Italy
Centro di Riferimento Oncologico IRCCS
Aviano, Friuli Venezia Giulia 33081
Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Naples, Napoli 80131
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany 56100
Italy
Istituto Europeo Di Oncologia
Milan, 20139
Italy
Azienda Ospedaliera Universitaria Senese
Siena,
Italy
Nederlands Kanker Instituut
Amsterdam, 1066 CX
Netherlands
National Cancer Centre Singapore
Singapore, Singapore 168582
Singapore
Bundang Medical Center - CHA University
Seongnam-si, Gyeonggi-do
South Korea
Samsung Medical Center
Seoul, South Korea 135-890
South Korea
Korea University Anam Hospital
Seoul, 2841
South Korea
Seoul National University Hospital
Seoul, 3080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722
South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga 29016
Spain
Institut Català d'Oncologia (ICO)
Barcelona, Spain 8908
Spain
HM Centro Integral Oncologico Clara Campal
Madrid, Spain 28050
Spain
Instituto Oncologico Rosell
Barcelona, 08028
Spain
Hospital Universitari Vall dHebron
Barcelona, 08035
Spain
Hospital Clinic de Barcelona
Barcelona, 8036
Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 8908
Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Spain
Hospital 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario Madrid Sanchinarro - CIOCC
Madrid, 28050
Spain
Hospital Universitario Quirónsalud Madrid
Madrid, 28223
Spain
Hospital Universitario Ramon y Cajal
Madrid,
Spain
Clínica Universitaria de Navarra
Pamplona, 31008
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County SE-41346
Sweden
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, 1011
Switzerland
Queen Elizabeth Hospital Birmingham
Birmingham, England B15 2GW
United Kingdom
Freeman Hospital
Newcastle upon Tyne, England NE7 7DN
United Kingdom
Royal Marsden Hospital
Chelsea, London SW3 6JJ
United Kingdom
Beaston West of Scotland Canter Centre
Glasgow, G120YN
United Kingdom
Guy's Hospital
London, SE1 9RT
United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD
United Kingdom