Supercharged immune cells take on advanced melanoma in new trial

NCT ID NCT02360579

Disease control Sponsor: Iovance Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a personalized cell therapy called lifileucel for people with advanced melanoma that had spread and stopped responding to standard treatments. Researchers took immune cells from each patient's tumor, multiplied them in a lab, and infused them back after mild chemotherapy. The study enrolled 220 participants and measured how many patients' tumors shrank or disappeared.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Lifileucel (a personalized cell therapy made from a patient's own immune cells that attack the tumor)
What this could lead to: If successful, this could offer a new treatment option for people with advanced melanoma that has stopped responding to other therapies.
What could go wrong: This is a phase 2 trial, so results are still early. The treatment involves intensive chemotherapy beforehand and may cause serious side effects. Not all patients will respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

220 people

The number who actually took part.

Started

Sep 2015

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic melanoma

Contacts and locations

Locations

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom
Atlantic Health System

Morristown, New Jersey, 07960, United States
Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom
California Pacific Medical Center

San Francisco, California, 94115, United States
Centre Hospitalier Lyon Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie

Lausanne, Switzerland
Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, 69008, France
Centro di Riferimento Oncologico di Aviano

Aviano, Pordenone, 33081, Italy
Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain
Consorci Hospital General Universitari de València

Valencia, Spain
Gustave Roussy Cancer Campus

Villejuif, Île-de-France Region, 94805, France
HM Centro Integral Oncológico Clara Campal

Madrid, 28050, Spain
Hospital 12 de Octubre

Madrid, 28041, Spain
Hospital Clinic de Barcelona

Barcelona, 08036, Spain
Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain
Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain
Hospital Universitario Quirónsalud Madrid

Madrid, 28233, Spain
Hôpital Dupuytren

Limoges, Limousin, 87042, France
Indiana University

Indianapolis, Indiana, 46202-5116, United States
Inselspital

Bern, 3010, Switzerland
Institut Català d'Oncologia

Barcelona, 08907, Spain
Istituto Europeo di Oncologia

Milan, 20141, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, 80131, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Forli-cesena, 47014, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia

Candiolo, Torino, 10060, Italy
James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States
Klinikum Rechts der Isar der Technischen Universität München

München, Bavaria, 81675, Germany
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States
New York University Langone Medical Center

New York, New York, 10016, United States
Providence Cancer Center Oncology and Hematology Care Clinic

Portland, Oregon, 97213, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom
Rutgers University

New Brunswick, New Jersey, United States
Sarah Cannon Research Institute London

London, W1G 6AD, United Kingdom
Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Szegedi Tudomanyegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye, 6720, Hungary
The Angeles Clinic and Research Institute

Los Angeles, California, 90048, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19701, United States
Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitaetsklinikum Tuebingen (UKT) - Suedwestdeutschen Tumorzentrum - Zentrum für Neuroonkologie

Tübingen, Baden-Wurttemberg, 72076, Germany
University of California Los Angeles - David Geffen School of Medicine - Westwood Rheumatology

Los Angeles, California, 90095, United States
University of California San Diego Moores Cancer Center

La Jolla, California, 92093, United States
University of Colorado Cancer Center

Aurora, Colorado, 80049, United States
University of Florida Health Cancer Center

Orlando, Florida, 32806, United States
University of Miami

Miami, Florida, 33136, United States
University of Minnesota, Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States
University of Pittsburgh Medical Center - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
University of South Florida H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States
Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany
Universitätsklinikum Erlangen

Erlangen, Bavaria, 91052, Germany
Universitätsklinikum Halle

Halle, Saxony-Anhalt, 06120, Germany
Universitätsklinikum Leipzig

Leipzig, Saxony, 4103, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany
Universitätsklinikum Würzburg

Würzburg, 97080, Germany
Virginia Commonwealth University

Richmond, Virginia, 23298, United States
Yale Cancer Center

New Haven, Connecticut, 06510, United States

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