Phase
Condition
Metastatic Melanoma
Melanoma
Treatment
Lifileucel plus Pembrolizumab
Pembrolizumab with Optional Crossover Period
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has a histologically or pathologically confirmed diagnosis of StageIIIC, IIID, or IV unresectable or metastatic melanoma.
In the investigator's assessment, the participant has an Eastern CooperativeOncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancyof > 6 months.
Participant is assessed as having at least one resectable lesion (or aggregatelesions) for lifileucel generation.
Participant must have at least one measurable disease as defined by RECIST 1.1following tumor resection.
Participants must have adequate organ function.
Participants of childbearing potential or those with partners of childbearingpotential must be willing to practice an approved method of highly effective birthcontrol.
Participants who are > 70 years of age may be allowed to enroll after theinvestigator discusses with the medical monitor.
Exclusion
Exclusion Criteria:
Participant has melanoma of uveal/ocular origin.
Participant has symptomatic untreated brain metastases.
Participant received more than 1 prior line of therapy.
Participant received prior therapy for metastatic disease
Participants with a BRAF V600 mutation-positive tumor received prioradjuvant/neoadjuvant ICI therapy only
Participant has an active medical illness(es) that, in the opinion of theinvestigator, would pose increased risks for study participation, such as systemicinfections; seizure disorders; coagulation disorders; or other active major medicalillnesses 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 forthose that do not require treatment or were curatively treated >1 year ago, and inthe judgment of the investigator do not pose a significant risk of recurrence.)
Participant has a history of allogeneic cell or organ transplant.
Other protocol defined inclusion/exclusion criteria could apply.
Study Design
Study Description
Connect with a study center
Greenslopes Private Hospital
Greenslopes, Queensland 4120
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia 6150
AustraliaActive - Recruiting
Westmead Hospital
Westmead, NSW 2145
AustraliaActive - Recruiting
Universitair Ziekenhuis Brussel - Oncologisch Centrum
Jette,
BelgiumActive - Recruiting
Centre hospitalier de l'Université de Montréal
Montréal, Quebec H2L 4M1
CanadaActive - Recruiting
Princess Margaret Cancer Centre
Toronto, M5G
CanadaActive - Recruiting
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, 44093
FranceActive - Recruiting
Hopital Saint Louis
Paris, 75475
FranceActive - Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
GermanyActive - Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, 23562
GermanyActive - Recruiting
Klinikum Rechts der Isar der Technischen Universität München
Munich, 81675
GermanyActive - Recruiting
Hadassah Medical Center
Jerusalem,
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, 52621
IsraelActive - Recruiting
Istituto Romagnolo per lo Studio dei Tumori
Meldola, Forlì-Cesena 47014
ItalyActive - Recruiting
Centro di Riferimento Oncologico IRCCS
Aviano, Friuli-Venezia Giulia 33081
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Toscana 56100
ItalyActive - Recruiting
Istituto Europeo Di Oncologia
Milan, 20139
ItalyActive - Recruiting
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, 80131
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Senese
Siena,
ItalyActive - Recruiting
Bundang Medical Center - CHA University
Seongnam-si, Gyeonggi-do
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 3080
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
Korea, Republic ofActive - Recruiting
Nederlands Kanker Instituut
Amsterdam, 1066 CX
NetherlandsActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainActive - Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Malaga, Málaga 29016
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 8036
SpainActive - Recruiting
Hospital Universitari Vall dHebron
Barcelona, 08035
SpainActive - Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 8908
SpainActive - Recruiting
Instituto Oncologico Rosell
Barcelona, 08028
SpainActive - Recruiting
Hospital 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario Madrid Sanchinarro - CIOCC
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario Quirónsalud Madrid
Madrid, 28223
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal
Madrid,
SpainActive - Recruiting
Clínica Universitaria de Navarra
Pamplona, 31008
SpainActive - Recruiting
Hospital Universitario Virgen Macarena
Sevilla, 41009
SpainActive - Recruiting
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
SpainActive - Recruiting
Sahlgrenska Universitetssjukhuset
Göteborg, Vastra Gotalands Lan SE-41346
SwedenActive - Recruiting
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, 1011
SwitzerlandActive - Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, England B15 2GW
United KingdomActive - Recruiting
Freeman Hospital
Newcastle upon Tyne, England NE7 7DN
United KingdomActive - Recruiting
Royal Marsden Hospital
Chelsea, London SW3 6JJ
United KingdomActive - Recruiting
Beaston West of Scotland Canter Centre
Glasgow, G120YN
United KingdomActive - Recruiting
Guy's Hospital
London, SE1 9RT
United KingdomActive - Recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
United KingdomActive - Recruiting
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama 35233
United StatesActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California 90007
United StatesActive - Recruiting
California Pacific Medical Center
San Francisco, California 94107
United StatesActive - Recruiting
University of Colorado Cancer Center
Aurora, Colorado 80045
United StatesActive - Recruiting
Orlando Health Cancer Institute
Orlando, Florida 32806
United StatesActive - Recruiting
University of Illinois Hospital & Health Sciences System
Chicago, Illinois 60612
United StatesActive - Recruiting
University of Kansas
Kansas City, Kansas 66205
United StatesActive - Recruiting
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky 40202
United StatesActive - Recruiting
National Cancer Institute
Bethesda, Maryland 20814
United StatesActive - Recruiting
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan 48201
United StatesActive - Recruiting
Henry Ford Health
Detroit, Michigan 48202
United StatesActive - Recruiting
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
Lebanon, New Hampshire 03756
United StatesActive - Recruiting
MD Anderson Cancer Center at Cooper
Camden, New Jersey 08103
United StatesActive - Recruiting
Oncology Hematology Care
Cincinnati, Ohio 45226
United StatesActive - Recruiting
Ohio State University
Columbus, Ohio 43201
United StatesActive - Recruiting
St. Luke's Cancer Center - Anderson
Easton, Pennsylvania 18045
United StatesActive - Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
Baptist Cancer Center
Bartlett, Tennessee 37920
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesActive - Recruiting
Swedish Cancer Institute
Edmonds, Washington 98026
United StatesActive - Recruiting
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