Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
- Registration Number
- NCT02360579
- Lead Sponsor
- Iovance Biotherapeutics, Inc.
- Brief Summary
Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen.
- Detailed Description
Lifileucel is an autologous adoptive cell transfer therapy that utilizes a TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with metastatic melanoma. The adoptive cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preconditioning regimen, prior to infusion of autologous TIL, followed by the administration of a regimen of IL-2.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 4 Lifileucel Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) Cohort 1 Lifileucel Lifileucel (LN-144) without cryopreservation (Gen 1 infusion product) (Closed) Cohort 2 Lifileucel Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Cohort 3 Lifileucel Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b).
- Primary Outcome Measures
Name Time Method Disease Assessment for Objective Response Rate Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Secondary Outcome Measures
Name Time Method Overall Survival Until death or up to 60 months Evaluate overall survival (OS) and objective response rate (ORR) by the investigator
Disease Assessment for Duration of Response Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months Evaluate the efficacy endpoints of duration of response (DOR) by the BIRC and by the investigator per RECIST v1.1
Adverse Events Maximum 60 months Incidence rate of treatment-emergent adverse events (AEs) and serious AEs by severity and relationship to Lifileucel (LN-144).
Disease Assessment for Disease Control Rate Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months Evaluate the efficacy endpoints of disease control rate (DCR) as assessed by the BIRC and by the investigator per RECIST v1.1
Disease Assessment for Progression-Free Survival Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the BIRC and by the investigator per RECIST v1.1
Trial Locations
- Locations (57)
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
Royal Marsden NHS Trust
🇬🇧London, England, United Kingdom
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
🇩🇪Lübeck, Schleswig-holstein, Germany
Rutgers University
🇺🇸New Brunswick, New Jersey, United States
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
🇮🇹Candiolo, Torino, Italy
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Universitätsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Forli-cesena, Italy
Universitaetsklinikum Tuebingen (UKT) - Suedwestdeutschen Tumorzentrum - Zentrum für Neuroonkologie
🇩🇪Tübingen, Baden-wuerttemberg, Germany
Gustave Roussy Cancer Campus
🇫🇷Villejuif Cedex, Ile-de-france, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, Rhone-alpes, France
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Universitätsklinikum Halle
🇩🇪Halle/Saale, Sachsen-anhalt, Germany
Szegedi Tudomanyegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrad, Hungary
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Atlantic Health System
🇺🇸Morristown, New Jersey, United States
Centre Léon Bérard
🇫🇷Lyon, Rhone-alpes, France
Klinikum Rechts der Isar der Technischen Universität München
🇩🇪München, Bayern, Germany
Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Sachsen, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Baden-wuerttemberg, Germany
University of California San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
University of California Los Angeles - David Geffen School of Medicine - Westwood Rheumatology
🇺🇸Los Angeles, California, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
University of Pittsburgh Medical Center - Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Hôpital Dupuytren
🇫🇷Limoges cedex, Limousin, France
Centro di Riferimento Oncologico di Aviano
🇮🇹Aviano, Pordenone, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
🇮🇹Napoli, Italy
Clínica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Institut Català d'Oncologia
🇪🇸Barcelona, Spain
HM Centro Integral Oncológico Clara Campal
🇪🇸Madrid, Spain
Consorci Hospital General Universitari de València
🇪🇸Valencia, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Inselspital
🇨🇭Bern, Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie
🇨🇭Lausanne, Switzerland
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Sarah Cannon Research Institute London
🇬🇧London, United Kingdom
Hospital Universitario Quirónsalud Madrid
🇪🇸Madrid, Spain
University of Florida Health Cancer Center
🇺🇸Orlando, Florida, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
University of South Florida H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
University of Miami
🇺🇸Miami, Florida, United States
University of Minnesota, Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Providence Cancer Center Oncology and Hematology Care Clinic
🇺🇸Portland, Oregon, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
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