Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

Part of paid clinical trials in La Jolla, California.

Sponsor
Iovance Biotherapeutics, Inc.
Study ID
NCT02360579
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lifileucel — BIOLOGICAL
    A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.

Study Details

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.

Key Dates

Start date
Sep 24, 2015
Status verified
Mar 2026
Primary completion
Oct 24, 2024
Completion
Oct 24, 2024

Study Design

Enrollment
220 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)
  • Experimental: Cohort 2
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
  • Experimental: Cohort 3
    Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b).
  • Experimental: Cohort 4
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)

Primary Outcome Measure

Disease Assessment for Objective Response Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months ]

Locations (23)

FacilityCityStateZIPSite coordinators
University of California San Diego Moores Cancer CenterLa JollaCalifornia92093-
The Angeles Clinic and Research InstituteLos AngelesCalifornia90048-
University of California Los Angeles - David Geffen School of Medicine - Westwood RheumatologyLos AngelesCalifornia90095-
California Pacific Medical CenterSan FranciscoCalifornia94115-
University of Colorado Cancer CenterAuroraColorado80049-
Yale Cancer CenterNew HavenConnecticut06510-
University of MiamiMiamiFlorida33136-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
University of Florida Health Cancer CenterOrlandoFlorida32806-
University of South Florida H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Indiana UniversityIndianapolisIndiana46202-5116-
James Graham Brown Cancer CenterLouisvilleKentucky40202-
University of Minnesota, Masonic Cancer CenterMinneapolisMinnesota55455-
Atlantic Health SystemMorristownNew Jersey07960-
Rutgers UniversityNew BrunswickNew Jersey--
Roswell Park Cancer InstituteBuffaloNew York14263-
New York University Langone Medical CenterNew YorkNew York10016-
Providence Cancer Center Oncology and Hematology Care ClinicPortlandOregon97213-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19701-
University of Pittsburgh Medical Center - Hillman Cancer CenterPittsburghPennsylvania15232-
Virginia Commonwealth UniversityRichmondVirginia23298-
Seattle Cancer Care AllianceSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53226-

Related coverage on Hipa.ai

Find similar trials in La Jolla, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of California San Diego Moores Cancer Center· La Jolla, CAThe Angeles Clinic and Research Institute· Los Angeles, CAUniversity of California Los Angeles - David Geffen School of Medicine - Westwood Rheumatology· Los Angeles, CACalifornia Pacific Medical Center· San Francisco, CAUniversity of Colorado Cancer Center· Aurora, COYale Cancer Center· New Haven, CT

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