Studie for å undersøke Lifileucel-regime pluss Pembrolizumab sammenlignet med Pembrolizumab alene hos deltakere med ubehandlet avansert melanom.
En fase 3, multisenter, randomisert, åpen etikett, parallell gruppe, behandlingsstudie for å vurdere effektiviteten og sikkerheten til lifileucel (LN-144, autologe tumorinfiltrerende lymfocytter [TIL]) regime i kombinasjon med pembrolizumab sammenlignet med pembrolizumab monoterapi i participants Med ubehandlet, uoperabelt eller metastatisk melanom
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Utvidet tilgang
Kontakter og plasseringer
Studiekontakt
- Navn: Iovance Biotherapeutics Study Team
- Telefonnummer: 1-844-845-4682
- E-post: Clinical.Inquiries@iovance.com
Studer Kontakt Backup
- Navn: Iovance Biotherapeutics https://www.tilvance-301.com
- Telefonnummer: 1-844-845-4682
- E-post: Clinical.Inquiries@iovance.com
Studiesteder
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Bedford Park, Australia, 5042
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- Flinders Medical Centre
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Westmead, Australia, NSW 2145
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- Westmead Hospital
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Queensland
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Greenslopes, Queensland, Australia, 4120
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- Greenslopes Private Hospital
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Victoria
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Melbourne, Victoria, Australia, 3000
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- Peter MacCallum Cancer Centre
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Western Australia
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Murdoch, Western Australia, Australia, 6150
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- Fiona Stanley Hospital
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Jette, Belgia
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- Universitair Ziekenhuis Brussel - Oncologisch Centrum
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Toronto, Canada, M5G
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- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
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- Centre hospitalier de l'Université de Montréal
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Finland
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Helsinki, Finland, Finland, 290
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- Helsinki University Hospital Comprehensive Cancer Center
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Alabama
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Birmingham, Alabama, Forente stater, 35233
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- University of Alabama at Birmingham: The Kirklin Clinic
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California
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Duarte, California, Forente stater, 91010
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- City of Hope
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Los Angeles, California, Forente stater, 90007
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- USC Norris Comprehensive Cancer Center
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San Francisco, California, Forente stater, 94107
- Tilbaketrukket
- California Pacific Medical Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
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- University of Colorado Cancer Center
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Florida
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Orlando, Florida, Forente stater, 32806
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- Orlando Health Cancer Institute
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Tilbaketrukket
- University of Illinois Hospital & Health Sciences System
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Kansas
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Kansas City, Kansas, Forente stater, 66205
- Tilbaketrukket
- University of Kansas
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- Tilbaketrukket
- University of Louisville - James Graham Brown Cancer Center
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Maryland
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Bethesda, Maryland, Forente stater, 20814
- Rekruttering
- National Cancer Institute
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Michigan
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Detroit, Michigan, Forente stater, 48201
- Tilbaketrukket
- Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
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Detroit, Michigan, Forente stater, 48202
- Tilbaketrukket
- Henry Ford Health
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
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- University of Minnesota
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
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- Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
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New Jersey
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Camden, New Jersey, Forente stater, 08103
- Rekruttering
- MD Anderson Cancer Center at Cooper
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Ohio
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Cincinnati, Ohio, Forente stater, 45226
- Rekruttering
- Oncology Hematology Care
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Columbus, Ohio, Forente stater, 43201
- Rekruttering
- Ohio State University
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Pennsylvania
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Easton, Pennsylvania, Forente stater, 18045
- Tilbaketrukket
- St. Luke's Cancer Center - Anderson
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Pittsburgh, Pennsylvania, Forente stater, 15224
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- Allegheny Health Network
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Tennessee
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Bartlett, Tennessee, Forente stater, 37920
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- Baptist Cancer Center
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- SCRI Oncology Partners
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Utah
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Salt Lake City, Utah, Forente stater, 84112
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- Intermountain Health
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Virginia
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Richmond, Virginia, Forente stater, 23298
- Tilbaketrukket
- Virginia Commonwealth University
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Washington
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Edmonds, Washington, Forente stater, 98026
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- Swedish Cancer Institute
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Marseille, Frankrike, 13009
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- Institut Paoli Calmettes
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Nantes, Frankrike, 44093
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- Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
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Paris, Frankrike, 75475
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- Hopital Saint Louis
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Jerusalem, Israel
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- Hadassah Medical Center
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Ramat Gan, Israel, 52621
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- Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Tilbaketrukket
- Tel Aviv Sourasky Medical Center
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Milan, Italia, 20139
- Tilbaketrukket
- Istituto Europeo Di Oncologia
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Siena, Italia
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- Azienda Ospedaliera Universitaria Senese
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Forlì-Cesena
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Meldola, Forlì-Cesena, Italia, 47014
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- Istituto Romagnolo per lo Studio dei Tumori
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Friuli Venezia Giulia
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Aviano, Friuli Venezia Giulia, Italia, 33081
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- Centro di Riferimento Oncologico IRCCS
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Napoli
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Naples, Napoli, Italia, 80131
- Rekruttering
- Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
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Tuscany
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Pisa, Tuscany, Italia, 56100
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- Azienda Ospedaliero Universitaria Pisana
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Amsterdam, Nederland, 1066 CX
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- Nederlands Kanker Instituut
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Singapore
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Singapore, Singapore, Singapore, 168582
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- National Cancer Centre Singapore
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Barcelona, Spania, 8036
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- Hospital Clinic de Barcelona
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Barcelona, Spania, 08028
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- Instituto Oncologico Rosell
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Barcelona, Spania, 08035
- Tilbaketrukket
- Hospital Universitari Vall dHebron
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Barcelona, Spania, 8908
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- ICO l'Hospitalet - Hospital Duran i Reynals
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Madrid, Spania, 28041
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- Hospital 12 de Octubre
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Madrid, Spania
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- Hospital Universitario Ramon y Cajal
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Madrid, Spania, 28050
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- Hospital Universitario Madrid Sanchinarro - CIOCC
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Madrid, Spania, 28007
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- Hospital General Universitario Gregorio Maranon
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Madrid, Spania, 28223
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- Hospital Universitario Quirónsalud Madrid
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Pamplona, Spania, 31008
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- Clínica Universitaria de Navarra
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Seville, Spania, 41009
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- Hospital Universitario Virgen Macarena
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Valencia, Spania, 46014
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- Consorcio Hospital General Universitario de Valencia
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Cantabria
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Santander, Cantabria, Spania, 39008
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- Hospital Universitario Marques de Valdecilla
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Málaga
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Málaga, Málaga, Spania, 29016
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- Hospital Regional Universitario de Malaga - Hospital General
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Spain
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Barcelona, Spain, Spania, 8908
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- Institut Català d'Oncologia (ICO)
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Madrid, Spain, Spania, 28050
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- HM Centro Integral Oncologico Clara Campal
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Glasgow, Storbritannia, G120YN
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- Beaston West of Scotland Canter Centre
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London, Storbritannia, W1G 6AD
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- Sarah Cannon Research Institute UK
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London, Storbritannia, SE1 9RT
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- Guy's Hospital
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England
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Birmingham, England, Storbritannia, B15 2GW
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- Queen Elizabeth Hospital Birmingham
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Newcastle upon Tyne, England, Storbritannia, NE7 7DN
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- Freeman Hospital
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London
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Chelsea, London, Storbritannia, SW3 6JJ
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- Royal Marsden Hospital
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Lausanne, Sveits, 1011
- Rekruttering
- Centre Hospitalier Universitaire Vaudois Lausanne
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Västra Götaland County
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Gothenburg, Västra Götaland County, Sverige, SE-41346
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- Sahlgrenska Universitetssjukhuset
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Seoul, Sør -Korea, 3722
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- Severance Hospital, Yonsei University Health System
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Seoul, Sør -Korea, 3080
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- Seoul National University Hospital
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Seoul, Sør -Korea, 2841
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- Korea University Anam Hospital
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Sør -Korea
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- Bundang Medical Center - CHA University
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South Korea
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Seoul, South Korea, Sør -Korea, 135-890
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- Samsung Medical Center
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Dresden, Tyskland, 1307
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- Universitätsklinikum Carl Gustav Carus
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Hamburg, Tyskland, 20251
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- Universitätsklinikum Hamburg-Eppendorf
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Lübeck, Tyskland, 23562
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- Universitätsklinikum Schleswig-Holstein - Campus Lübeck
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Munich, Tyskland, 81675
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- Klinikum Rechts der Isar der Technischen Universität München
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Germany
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Berlin, Germany, Tyskland, 13353
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- Charité - Universitätsmedizin Berlin
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Würzburg, Germany, Tyskland, 97080
- Rekruttering
- Universitätsklinikum Würzburg
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
- 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.
- Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
- Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
- Participants must have adequate organ function.
- Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
- Participants who are > 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
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 prior adjuvant/neoadjuvant ICI therapy only
- 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.
- Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
- 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.)
- Participant has a history of allogeneic cell or organ transplant.
Other protocol defined inclusion/exclusion criteria could apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Arm A
Lifileucel plus Pembrolizumab |
A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive Pembrolizumab followed by the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. Patients will then continue to receive Pembrolizumab every 6 weeks until disease progression.
Andre navn:
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Aktiv komparator: Arm B
Pembrolizumab alone with Optional Crossover Period |
Patient will receive Pembrolizumab monotherapy every 6 weeks until disease progression. Upon verified confirmed disease progression by the blinded independent review central committee, patients may proceed to lifileucel monotherapy during an optional crossover period if they meet eligibility criteria. Optional crossover: A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate and Progression Free Survival
Tidsramme: 5 years total duration
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To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by objective response rate (ORR) and progression-free survival (PFS) assessed by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
5 years total duration
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: 7 years total duration
|
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by overall survival (OS) |
7 years total duration
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|
Complete Response Rate, Duration of Response and Event Free Survival
Tidsramme: 5 years total duration
|
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by complete response (CR) rate and duration of response (DOR) and event- free survival (EFS) assessed by the BIRC per RECIST v1.1 |
5 years total duration
|
|
Objective Response Rate, Progression Free Survival, Complete Response Rate, Duration of Responses, Event Free Survival and PFS2
Tidsramme: 5 years total duration
|
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by ORR, PFS, CR rate, DOR, and EFS assessed by the investigator per RECIST v1.1 and PFS2 assessed by the investigator |
5 years total duration
|
|
Adverse Events
Tidsramme: 5 years total duration
|
To characterize the safety and tolerability profile of lifileucel plus pembrolizumab and pembrolizumab alone in participants with unresectable or metastatic melanoma |
5 years total duration
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Iovance Biotherapeutics Study Team, Iovance Biotherapeutics
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- Celleterapi
- Pembrolizumab
- Melanom
- Ondartet melanom
- Hudkreft
- Tumorinfiltrerende lymfocytter
- IL-2
- TIL
- Immunkontrollpunkthemmer
- Autolog adoptiv celleoverføring
- Autolog adoptiv celleterapi
- Cellulær immunterapi
- LN-144
- Lifileucel
- Metastatisk melanom
- Uopererbart melanom
- Stage IV melanom
- ICI
- Stage III melanom
- Sjekkpunkthemmer
- Hudkrefttyper
- Ikke-myeloablativ lymfodeplesjon (NMALD)
- Pembro
- Adjuvans/Neo-adjuvans
- BRAF/MEK
- BRAF v600
- Tumorinfiltrerende T-celler
- TILVANCE
- TILVANCE-301
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IOV-MEL-301
- TILVANCE-301 (Annen identifikator: Iovance Biotherapeutics, Inc.)
- TILVANCE (Annen identifikator: Iovance Biotherapeutics, Inc.)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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