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RECRUITING
NCT03645928
PHASE2

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Sponsor: Iovance Biotherapeutics, Inc.

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

BIOLOGICAL

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.

DRUG

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.

BIOLOGICAL

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.

DRUG

Ipilimumab

Monoclonal antibody Ipilimumab will be administered as a single dose prior to tumor resection.

DRUG

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.

DRUG

Nivolumab-relatlimab

Nivolumab-relatlimab will be administered following tumor resection and will continue every 4 weeks thereafter for up to 2 years.

DRUG

Cisplatin

Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

DRUG

Carboplatin

Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

DRUG

Paclitaxel

Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

DRUG

Nab-Paclitaxel

Nab-Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

DRUG

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