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Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
Sponsor: Iovance Biotherapeutics, Inc.
Summary
A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL \[LN-144/LN-145 (lifileucel)\] in combination with immune checkpoint inhibitors or TIL \[LN-144/LN-145 (lifileucel) and LN-145-S1\] as a single agent therapy.
Official title: A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
245
Start Date
2019-05-07
Completion Date
2029-08-09
Last Updated
2025-06-19
Healthy Volunteers
No
Interventions
Lifileucel
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with Lifileucel followed by aldesleukin administration. Lifileucel will be administered to patients once (on Day 0) during the study.
LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by aldesleukin administration. TIL will be administered to patients once (on Day 0) during the study.
Pembrolizumab
Humanized antibody. Pembrolizumab will be administered following tumor resection and will continue every 3 weeks or every 6 weeks thereafter for up to 2 years.
LN-145-S1
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145-S1) followed by aldesleukin administration. TIL will be administered to patients once (on Day 0) during the study.
Ipilimumab
Monoclonal antibody Ipilimumab will be administered as a single dose prior to tumor resection.
Nivolumab
Monoclonal antibody Nivolumab will be administered once prior to tumor resection. The second dose will be administered prior to TIL administration and dosing will continue every 4 weeks for up to 2 years.
Nivolumab-relatlimab
Nivolumab-relatlimab will be administered following tumor resection and will continue every 4 weeks thereafter for up to 2 years.
Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Paclitaxel
Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Nab-Paclitaxel
Nab-Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Pemetrexed
Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if applicable.
Locations (45)
University of California, San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of Colorado
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Louisville
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
MD Anderson at Cooper
Camden, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Columbia University
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Huntsman Cancer Hospital
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Léon Berard
Lyon, France
Klinikum rechts der Isar der Technischen Universität München
München, Bavaria, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
Laiko General Hospital of Athens
Athens, Attica, Greece
Attikon University General Hospital
Athens, Attica, Greece
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga, Spain
University Hospital Vall d'Hebron
Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Universitätsspital Basel
Basel, Switzerland
Universitaetsspital Bern
Bern, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Guy's Hospital
London, England, United Kingdom
The Royal Marsden NHS Foundation Trust
London, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom