search
Back to results

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

Primary Purpose

Metastatic Melanoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lifileucel
Sponsored by
Iovance Biotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring Autologous Adoptive Cell Transfer, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Cell Therapy, Tumor Infiltrating Lymphocytes, TIL, LN-144, IL-2, Melanoma, Lifileucel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients must meet all of the following inclusion criteria to be eligible for participation in the study:

Criteria for Inclusion:

  1. Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV)
  2. Patients must have progressed following ≥ one prior systemic therapy including a programmed cell death protein-1 (PD-1) blocking antibody; and if proto-oncogene B-Raf (BRAF) V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor
  3. At least one measurable target lesion, as defined by RECIST v1.1

    • Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion
  4. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)
  5. Patients must be ≥ 18 years of age at the time of consent. Enrollment of patients > 70 years of age may be allowed after consultation with the Medical Monitor
  6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months
  7. In the opinion of the Investigator, patients must be able to complete all study-required procedures
  8. Patients must have the following hematologic parameters:

    • Absolute neutrophil count (ANC) ≥ 1000/mm3
    • Hemoglobin (Hb) ≥ 9.0 g/dL
    • Platelet ≥ 100,000/mm3
  9. Patients must have adequate organ function:

    • Serum alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) and aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 times the upper limit of normal (ULN); patients with liver metastasis ≤ 5 times ULN
    • Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula
    • Total bilirubin ≤ 2 mg/dL
    • Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg/dL
  10. Patients must have recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v4.03), except for alopecia or vitiligo, prior to Enrollment (tumor resection)

    • Patients with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and/or had a normal colonoscopy post-immune checkpoint inhibitor treatment, by visual assessment, prior to tumor resection
  11. Patients must have a washout period ≥ 28 days from prior anticancer therapy(ies) to the start of the planned NMA-LD preconditioning regimen:

    • Targeted therapy: MEK/BRAF or other targeted agent
    • Chemotherapy
    • Immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine
    • Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v4.03
  12. Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy

    • Approved methods of birth control are as follows:
    • Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal
    • Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable
    • Intrauterine device (IUD)
    • Intrauterine hormone-releasing system (IUS)
    • Bilateral tubal occlusion
    • Vasectomized partner
    • True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable
  13. Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period
  14. Patients have provided written authorization for use and disclosure of protected health information

Criteria for Exclusion:

Patients who meet any of the following criteria are not eligible for participation in this study:

  1. Patients who have been shown to be BRAF mutation positive (V600), but have not received prior systemic therapy with a BRAF inhibitor alone or a BRAF inhibitor in combination with a MEK inhibitor
  2. Patients who have received an organ allograft or prior cell transfer therapy
  3. Patients with melanoma of uveal/ocular origin
  4. Patients who have a history of hypersensitivity to any component or excipient of LN-144 or other study drugs:

    • NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)
    • Antibiotics (ABX) of the aminoglycoside group (ie, streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity
    • Any component of the LN-144 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40
  5. Patients with symptomatic and/or untreated brain metastases (of any size and any number)

    • Patients with definitively treated brain metastases may be considered for Enrollment, and must be stable for ≥ 14 days prior to beginning the NMA LD preconditioning regimen
  6. Patients who are on chronic systemic steroid therapy for any reason
  7. Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system
  8. Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease [SCID] and acquired immunodeficiency syndrome [AIDS])
  9. Patients who have a left ventricular ejection fraction (LVEF) < 45% or New York Heart Association (NYHA) functional classification > Class 1

    • Patients ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias must have a cardiac stress test. Patients with any irreversible wall movement abnormalities are excluded
  10. Patients who have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60%
  11. Patients who have had another primary malignancy within the previous 3 years (with the exception of carcinoma in situ of the breast, cervix, or bladder; localized prostate cancer; and non-melanoma skin cancer that has been adequately treated)
  12. Patients who have received a live or attenuated vaccine within 28 days of beginning the NMA-LD preconditioning regimen
  13. Patients who are pregnant or breastfeeding
  14. Patients whose cancer requires immediate attention or who would otherwise suffer a disadvantage by participating in this trial
  15. Patients protected by the following constraints:

    • Hospitalized persons without consent or persons deprived of liberty because of a judiciary or administrative decision
    • Adult persons with a legal protection measure or persons who cannot express their consent
    • Patients in emergency situations who cannot consent to participate in the trial

Sites / Locations

  • University of California San Diego Moores Cancer Center
  • The Angeles Clinic and Research Institute
  • University of California Los Angeles - David Geffen School of Medicine - Westwood Rheumatology
  • California Pacific Medical Center
  • University of Colorado Cancer Center
  • Yale Cancer Center
  • Mount Sinai Comprehensive Cancer Center
  • University of Miami
  • University of Florida Health Cancer Center
  • University of South Florida H. Lee Moffitt Cancer Center and Research Institute
  • Indiana University
  • James Graham Brown Cancer Center
  • University of Minnesota, Masonic Cancer Center
  • Atlantic Health System
  • Rutgers University
  • Roswell Park Cancer Institute
  • New York University Langone Medical Center
  • Providence Cancer Center Oncology and Hematology Care Clinic
  • Thomas Jefferson University
  • University of Pittsburgh Medical Center - Hillman Cancer Center
  • Virginia Commonwealth University
  • Seattle Cancer Care Alliance
  • Medical College of Wisconsin
  • Gustave Roussy Cancer Campus
  • Hôpital Dupuytren
  • Centre Léon Bérard
  • Centre Hospitalier Lyon Sud
  • Universitaetsklinikum Heidelberg
  • Universitaetsklinikum Tuebingen (UKT) - Suedwestdeutschen Tumorzentrum - Zentrum für Neuroonkologie
  • Universitätsklinikum Erlangen
  • Klinikum Rechts der Isar der Technischen Universität München
  • Universitätsklinikum Halle
  • Universitätsklinikum Carl Gustav Carus
  • Universitätsklinikum Leipzig
  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
  • Universitätsklinikum Würzburg
  • Szegedi Tudomanyegyetem Szent-Györgyi Albert Klinikai Központ
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Centro di Riferimento Oncologico di Aviano
  • Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
  • Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Clínica Universidad de Navarra
  • Hospital Universitari Vall d'Hebrón
  • Hospital Clinic de Barcelona
  • Institut Català d'Oncologia
  • Hospital General Universitario Gregorio Marañon
  • Hospital 12 de Octubre
  • HM Centro Integral Oncológico Clara Campal
  • Hospital Universitario Quirónsalud Madrid
  • Consorci Hospital General Universitari de València
  • Inselspital
  • Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie
  • Royal Marsden NHS Trust
  • Beatson West of Scotland Cancer Centre
  • Addenbrooke's Hospital
  • Sarah Cannon Research Institute London

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

Lifileucel (LN-144) without cryopreservation (Gen 1 infusion product) (Closed)

Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)

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).

Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)

Outcomes

Primary Outcome Measures

Disease Assessment for Objective Response Rate
Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Secondary Outcome Measures

Disease Assessment for Duration of Response
Evaluate the efficacy endpoints of duration of response (DOR) by the BIRC and by the investigator per RECIST v1.1
Disease Assessment for Disease Control Rate
Evaluate the efficacy endpoints of disease control rate (DCR) as assessed by the BIRC and by the investigator per RECIST v1.1
Disease Assessment for Progression-Free Survival
Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the BIRC and by the investigator per RECIST v1.1
Overall Survival
Evaluate overall survival (OS) and objective response rate (ORR) by the investigator
Adverse Events
Incidence rate of treatment-emergent adverse events (AEs) and serious AEs by severity and relationship to Lifileucel (LN-144).

Full Information

First Posted
February 3, 2015
Last Updated
July 10, 2023
Sponsor
Iovance Biotherapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02360579
Brief Title
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
Acronym
LN-144
Official Title
A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iovance Biotherapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Lifileucel is an autologous adoptive cell transfer therapy that utilizes a TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with metastatic melanoma. The adoptive cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preconditioning regimen, prior to infusion of autologous TIL, followed by the administration of a regimen of IL-2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Autologous Adoptive Cell Transfer, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Cell Therapy, Tumor Infiltrating Lymphocytes, TIL, LN-144, IL-2, Melanoma, Lifileucel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Lifileucel (LN-144) without cryopreservation (Gen 1 infusion product) (Closed)
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
Intervention Type
Biological
Intervention Name(s)
Lifileucel
Other Intervention Name(s)
LN - 144
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease Assessment for Objective Response Rate
Description
Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time Frame
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
Secondary Outcome Measure Information:
Title
Disease Assessment for Duration of Response
Description
Evaluate the efficacy endpoints of duration of response (DOR) by the BIRC and by the investigator per RECIST v1.1
Time Frame
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
Title
Disease Assessment for Disease Control Rate
Description
Evaluate the efficacy endpoints of disease control rate (DCR) as assessed by the BIRC and by the investigator per RECIST v1.1
Time Frame
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
Title
Disease Assessment for Progression-Free Survival
Description
Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the BIRC and by the investigator per RECIST v1.1
Time Frame
Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
Title
Overall Survival
Description
Evaluate overall survival (OS) and objective response rate (ORR) by the investigator
Time Frame
Until death or up to 60 months
Title
Adverse Events
Description
Incidence rate of treatment-emergent adverse events (AEs) and serious AEs by severity and relationship to Lifileucel (LN-144).
Time Frame
Maximum 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in the study: Criteria for Inclusion: Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV) Patients must have progressed following ≥ one prior systemic therapy including a programmed cell death protein-1 (PD-1) blocking antibody; and if proto-oncogene B-Raf (BRAF) V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor At least one measurable target lesion, as defined by RECIST v1.1 Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days) Patients must be ≥ 18 years of age at the time of consent. Enrollment of patients > 70 years of age may be allowed after consultation with the Medical Monitor Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months In the opinion of the Investigator, patients must be able to complete all study-required procedures Patients must have the following hematologic parameters: Absolute neutrophil count (ANC) ≥ 1000/mm3 Hemoglobin (Hb) ≥ 9.0 g/dL Platelet ≥ 100,000/mm3 Patients must have adequate organ function: Serum alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) and aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 times the upper limit of normal (ULN); patients with liver metastasis ≤ 5 times ULN Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula Total bilirubin ≤ 2 mg/dL Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg/dL Patients must have recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v4.03), except for alopecia or vitiligo, prior to Enrollment (tumor resection) Patients with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and/or had a normal colonoscopy post-immune checkpoint inhibitor treatment, by visual assessment, prior to tumor resection Patients must have a washout period ≥ 28 days from prior anticancer therapy(ies) to the start of the planned NMA-LD preconditioning regimen: Targeted therapy: MEK/BRAF or other targeted agent Chemotherapy Immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v4.03 Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy Approved methods of birth control are as follows: Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable Intrauterine device (IUD) Intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion Vasectomized partner True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period Patients have provided written authorization for use and disclosure of protected health information Criteria for Exclusion: Patients who meet any of the following criteria are not eligible for participation in this study: Patients who have been shown to be BRAF mutation positive (V600), but have not received prior systemic therapy with a BRAF inhibitor alone or a BRAF inhibitor in combination with a MEK inhibitor Patients who have received an organ allograft or prior cell transfer therapy Patients with melanoma of uveal/ocular origin Patients who have a history of hypersensitivity to any component or excipient of LN-144 or other study drugs: NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine) Antibiotics (ABX) of the aminoglycoside group (ie, streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity Any component of the LN-144 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40 Patients with symptomatic and/or untreated brain metastases (of any size and any number) Patients with definitively treated brain metastases may be considered for Enrollment, and must be stable for ≥ 14 days prior to beginning the NMA LD preconditioning regimen Patients who are on chronic systemic steroid therapy for any reason Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease [SCID] and acquired immunodeficiency syndrome [AIDS]) Patients who have a left ventricular ejection fraction (LVEF) < 45% or New York Heart Association (NYHA) functional classification > Class 1 Patients ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias must have a cardiac stress test. Patients with any irreversible wall movement abnormalities are excluded Patients who have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% Patients who have had another primary malignancy within the previous 3 years (with the exception of carcinoma in situ of the breast, cervix, or bladder; localized prostate cancer; and non-melanoma skin cancer that has been adequately treated) Patients who have received a live or attenuated vaccine within 28 days of beginning the NMA-LD preconditioning regimen Patients who are pregnant or breastfeeding Patients whose cancer requires immediate attention or who would otherwise suffer a disadvantage by participating in this trial Patients protected by the following constraints: Hospitalized persons without consent or persons deprived of liberty because of a judiciary or administrative decision Adult persons with a legal protection measure or persons who cannot express their consent Patients in emergency situations who cannot consent to participate in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iovance Biotherapeutics Medical Monitor
Organizational Affiliation
Iovance Biotherapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of California San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
The Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California Los Angeles - David Geffen School of Medicine - Westwood Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80049
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Florida Health Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5116
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Minnesota, Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Providence Cancer Center Oncology and Hematology Care Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19701
Country
United States
Facility Name
University of Pittsburgh Medical Center - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Gustave Roussy Cancer Campus
City
Villejuif Cedex
State/Province
Ile-de-france
ZIP/Postal Code
94805
Country
France
Facility Name
Hôpital Dupuytren
City
Limoges cedex
State/Province
Limousin
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
State/Province
Rhone-alpes
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
State/Province
Rhone-alpes
ZIP/Postal Code
69495
Country
France
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen (UKT) - Suedwestdeutschen Tumorzentrum - Zentrum für Neuroonkologie
City
Tübingen
State/Province
Baden-wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91052
Country
Germany
Facility Name
Klinikum Rechts der Isar der Technischen Universität München
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Halle
City
Halle/Saale
State/Province
Sachsen-anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
State/Province
Sachsen
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
4103
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
City
Lübeck
State/Province
Schleswig-holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Szegedi Tudomanyegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
State/Province
Forli-cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Centro di Riferimento Oncologico di Aviano
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Institut Català d'Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
HM Centro Integral Oncológico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Quirónsalud Madrid
City
Madrid
ZIP/Postal Code
28233
Country
Spain
Facility Name
Consorci Hospital General Universitari de València
City
Valencia
Country
Spain
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie
City
Lausanne
Country
Switzerland
Facility Name
Royal Marsden NHS Trust
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute London
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33979178
Citation
Sarnaik AA, Hamid O, Khushalani NI, Lewis KD, Medina T, Kluger HM, Thomas SS, Domingo-Musibay E, Pavlick AC, Whitman ED, Martin-Algarra S, Corrie P, Curti BD, Olah J, Lutzky J, Weber JS, Larkin JMG, Shi W, Takamura T, Jagasia M, Qin H, Wu X, Chartier C, Graf Finckenstein F, Fardis M, Kirkwood JM, Chesney JA. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. J Clin Oncol. 2021 Aug 20;39(24):2656-2666. doi: 10.1200/JCO.21.00612. Epub 2021 May 12. Erratum In: J Clin Oncol. 2021 Sep 10;39(26):2972.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs