RECRUITING

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

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Conditions

Metastatic MelanomaSquamous Cell Carcinoma of the Head and NeckNon-small Cell Lung CancerLN-144LN-145Cell TherapyAutologous Adoptive Cell TransferAutologous Adoptive Cell TherapyCellular Immuno-therapyTumor Infiltrating LymphocytesTILIL-2Multiple Tumor TypeLifileucelPembrolizumabLN-145-S1IpilimumabNivolumabICIImmune Checkpoint InhibitorAldesleukinNivolumab-relatlimabPlatinum doublet chemotherapy agentsCisplatinCarboplatinPaclitaxelNab-PaclitaxelMelanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2019-05-07
Study Completion:2029-08-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03645928

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Iovance Biotherapeutics Study Team
CONTACT
1-844-845-4682
Clinical.Inquiries@iovance.com

Principal Investigator

Iovance Biotherapeutics Medical Monitor
STUDY_DIRECTOR
Iovance Biotherapeutics

Study Locations (Sites)

University of California, San Diego
La Jolla, California, 92093
United States
University of Southern California
Los Angeles, California, 90007
United States
University of California, Los Angeles
Los Angeles, California, 90095
United States
University of Colorado
Denver, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06520
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140
United States
Orlando Health Cancer Institute
Orlando, Florida, 32610
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
University of Louisville
Louisville, Kentucky, 40292
United States
University of Maryland
Baltimore, Maryland, 21201
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
MD Anderson at Cooper
Camden, New Jersey, 08103
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Columbia University
New York, New York, 10027
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
Ohio State University
Columbus, Ohio, 43201
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Huntsman Cancer Hospital
Salt Lake City, Utah, 84112
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Iovance Biotherapeutics, Inc.

  • Iovance Biotherapeutics Medical Monitor, STUDY_DIRECTOR, Iovance Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-07
Study Completion Date2029-08-09

Study Record Updates

Study Start Date2019-05-07
Study Completion Date2029-08-09

Terms related to this study

Keywords Provided by Researchers

  • LN-144
  • LN-145
  • Cell Therapy
  • Autologous Adoptive Cell Transfer
  • Autologous Adoptive Cell Therapy
  • Cellular Immuno-therapy
  • Tumor Infiltrating Lymphocytes
  • TIL
  • IL-2
  • Multiple Tumor Type
  • Lifileucel
  • Pembrolizumab
  • LN-145-S1
  • Ipilimumab
  • Nivolumab
  • ICI
  • Immune Checkpoint Inhibitor
  • Aldesleukin
  • Nivolumab-relatlimab
  • Platinum doublet chemotherapy agents
  • Cisplatin
  • Carboplatin
  • Paclitaxel
  • Nab-Paclitaxel
  • Non-small cell lung cancer
  • Melanoma

Additional Relevant MeSH Terms

  • Metastatic Melanoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Non-small Cell Lung Cancer