Spots Global Cancer Trial Database for Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
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Trial Identification
Brief Title: Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
Official Title: A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma
Study ID: NCT02360579
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego Moores Cancer Center, La Jolla, California, United States
The Angeles Clinic and Research Institute, Los Angeles, California, United States
University of California Los Angeles - David Geffen School of Medicine - Westwood Rheumatology, Los Angeles, California, United States
California Pacific Medical Center, San Francisco, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
University of Miami, Miami, Florida, United States
University of Florida Health Cancer Center, Orlando, Florida, United States
University of South Florida H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Indiana University, Indianapolis, Indiana, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
University of Minnesota, Masonic Cancer Center, Minneapolis, Minnesota, United States
Atlantic Health System, Morristown, New Jersey, United States
Rutgers University, New Brunswick, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
New York University Langone Medical Center, New York, New York, United States
Providence Cancer Center Oncology and Hematology Care Clinic, Portland, Oregon, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Gustave Roussy Cancer Campus, Villejuif Cedex, Ile-de-france, France
Hôpital Dupuytren, Limoges cedex, Limousin, France
Centre Léon Bérard, Lyon, Rhone-alpes, France
Centre Hospitalier Lyon Sud, Pierre-Bénite, Rhone-alpes, France
Universitaetsklinikum Heidelberg, Heidelberg, Baden-wuerttemberg, Germany
Universitaetsklinikum Tuebingen (UKT) - Suedwestdeutschen Tumorzentrum - Zentrum für Neuroonkologie, Tübingen, Baden-wuerttemberg, Germany
Universitätsklinikum Erlangen, Erlangen, Bayern, Germany
Klinikum Rechts der Isar der Technischen Universität München, München, Bayern, Germany
Universitätsklinikum Halle, Halle/Saale, Sachsen-anhalt, Germany
Universitätsklinikum Carl Gustav Carus, Dresden, Sachsen, Germany
Universitätsklinikum Leipzig, Leipzig, Sachsen, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Lübeck, Schleswig-holstein, Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
Szegedi Tudomanyegyetem Szent-Györgyi Albert Klinikai Központ, Szeged, Csongrad, Hungary
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Forli-cesena, Italy
Centro di Riferimento Oncologico di Aviano, Aviano, Pordenone, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia, Candiolo, Torino, Italy
Istituto Europeo di Oncologia, Milano, , 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
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
HM Centro Integral Oncológico Clara Campal, Madrid, , Spain
Hospital Universitario Quirónsalud Madrid, Madrid, , Spain
Consorci Hospital General Universitari de València, Valencia, , Spain
Inselspital, Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie, Lausanne, , Switzerland
Royal Marsden NHS Trust, London, England, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
Sarah Cannon Research Institute London, London, , United Kingdom
Contact Details
Name: Iovance Biotherapeutics Medical Monitor
Affiliation: Iovance Biotherapeutics, Inc.
Role: STUDY_CHAIR
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