245
Participants
Start Date
May 7, 2019
Primary Completion Date
August 9, 2029
Study Completion Date
August 9, 2029
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.
TERMINATED
Centre Hospitalier Universitaire Vaudois, Lausanne
ACTIVE_NOT_RECRUITING
Universitaetsspital Bern, Bern
WITHDRAWN
Universitätsspital Basel, Basel
WITHDRAWN
Columbia University, New York
ACTIVE_NOT_RECRUITING
Memorial Sloan Kettering Cancer Center, New York
RECRUITING
Laiko General Hospital of Athens, Athens
ACTIVE_NOT_RECRUITING
Attikon University General Hospital, Athens
ACTIVE_NOT_RECRUITING
Georgetown University Medical Center, Washington D.C.
ACTIVE_NOT_RECRUITING
University of Maryland, Baltimore
RECRUITING
Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Lübeck
WITHDRAWN
Hospital General Universitario Gregorio Marañón, Madrid
RECRUITING
Hospital Universitario Fundacion Jimenez Diaz, Madrid
RECRUITING
Hospital Universitario 12 de Octubre, Madrid
RECRUITING
Hospital Universitario HM Sanchinarro, Madrid
TERMINATED
Hospital Regional Universitario de Malaga - Hospital General, Málaga
RECRUITING
Orlando Health Cancer Institute, Orlando
WITHDRAWN
Mount Sinai Medical Center, Miami Beach
ACTIVE_NOT_RECRUITING
Moffitt Cancer Center, Tampa
RECRUITING
Hospital Universitario Marques de Valdecilla, Santander
RECRUITING
University of Louisville, Louisville
RECRUITING
Ohio State University, Columbus
TERMINATED
University of Cincinnati, Cincinnati
ACTIVE_NOT_RECRUITING
Karmanos Cancer Institute, Detroit
ACTIVE_NOT_RECRUITING
Henry Ford Health System, Detroit
TERMINATED
Medical College of Wisconsin, Milwaukee
WITHDRAWN
Avera Cancer Institute, Sioux Falls
WITHDRAWN
Centre Léon Berard, Lyon
ACTIVE_NOT_RECRUITING
University of Colorado, Denver
WITHDRAWN
Klinikum rechts der Isar der Technischen Universität München, München
WITHDRAWN
Huntsman Cancer Hospital, Salt Lake City
ACTIVE_NOT_RECRUITING
University of Southern California, Los Angeles
ACTIVE_NOT_RECRUITING
University of California, Los Angeles, Los Angeles
TERMINATED
University of California, San Diego, La Jolla
RECRUITING
Fred Hutchinson Cancer Research Center, Seattle
ACTIVE_NOT_RECRUITING
Yale University, New Haven
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
MD Anderson at Cooper, Camden
RECRUITING
Morristown Medical Center, Morristown
ACTIVE_NOT_RECRUITING
Princess Margaret Cancer Centre, Toronto
WITHDRAWN
Universitätsklinikum Carl Gustav Carus, Dresden
WITHDRAWN
University Hospital Vall d'Hebron, Barcelona
RECRUITING
ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona
RECRUITING
Guy's Hospital, London
RECRUITING
The Royal Marsden NHS Foundation Trust, London
WITHDRAWN
Bristol Haematology and Oncology Centre, Bristol
Lead Sponsor
Iovance Biotherapeutics, Inc.
INDUSTRY