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Personalized cell therapy shows promise but trial ends early

NCT ID NCT03645928

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a personalized treatment using immune cells taken from a patient's own tumor, called tumor-infiltrating lymphocytes (TIL). The cells were grown in a lab and given back to the patient to fight their cancer. The trial included people with advanced melanoma, head and neck cancer, or non-small cell lung cancer. The study was terminated early, so the full results are not available, but the approach may still offer hope for future treatments.

What this could mean

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

Active substance
tumor-infiltrating lymphocytes (TIL) called lifileucel and LN-145
What this could lead to
If successful, this approach could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This trial was terminated early, so results are limited. TIL therapy is complex and can cause serious side effects, and it may not work for everyone.

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

225 people

The number who actually took part.

Started

May 2019

Finished

Feb 2026

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.

Inclusion Criteria * Must have a confirmed diagnosis of malignancy of their receptive \[RL7.1\]histologies: unresectable or metastatic melanoma Stage IIIC to IV (Cohorts 1A,1B and 1C), advanced, recurrent or metastatic HNSCC (Cohort 2A), or Stage III or Stage IV non-small cell lung cancer (Cohorts 3A, 3B, and 3C). Stage IV NSCLC with no actionable mutations (EGFR, ALK, ROS1) with effective targeted therapy (Cohorts 3D and 3E). * Cohorts 1A, 1D, 2A, 3A, 3D and 3E: If previously treated, patients must have progressed on or after most recent therapy and must not have received ICIs as part of one of the counted lines of prior therapy. Patients must have radiologically documented disease progression while receiving or after the completion of the most recent prior treatment. Patients may have received up to 3 prior systemic anticancer therapies (except for Cohort 3A, where patients whose tumors harbor actionable mutations may have received up to 4 prior systemic therapies). Patients in Cohort 1D may have had no prior therapy for advanced disease. Patients in Cohorts 3D and 3E may have had no prior systemic therapy for Stage IV disease. * Cohorts 1B, 1C, 3B, and 3C: Unresectable or metastatic melanoma patients in Cohorts 1B or 1C must have previously received systemic therapy with a PD-1 blocking antibody. NSCLC patients in Cohort 3B must have previously received systemic therapy with any ICI (except for those patients with known oncogene driver mutations that are sensitive to targeted therapies) as part of 1 - 3 prior lines of therapy. NSCLC patients in Cohort 3C must have previously received 1 line of ICI monotherapy. No other systemic therapy for metastatic disease is allowed. Prior chemoradiation and/or chemotherapy in the adjuvant and/or neoadjuvant settings are allowed. * Must have at least 1 resectable lesion * Must have remaining measurable disease as defined by RECIST 1.1 following tumor resection * Must be ≥ 18 years at the time of consent for Cohorts 1A, 1C, 1D, 2A, 3A, 3B, 3C, 3D and 3E. Patients must be ≥ 12 years at the time of consent for Cohort 1B. Enrollment of patients \> 70 years of age may be allowed after consultation with the Medical Monitor. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and an estimated life expectancy of ≥ 6 months. * Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of birth control during treatment and for 12 months after their last dose of aldesleukin, 4 months after their last dose of pembrolizumab, 5 months after their last dose of ipilimumab or nivolumab, or nivolumab-relatlimab; 6 months after the last dose of carboplatin; 14 months after the last dose of cisplatin; and 6 months after the last dose of pemetrexed, paclitaxel, or nab-paclitaxel, whichever occurs later. Exclusion Criteria * Patients with melanoma of uveal/ocular origin. * Patients who have a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years. Patients being retreated with TIL, as part of this study are not excluded. * Patients who have symptomatic, untreated brain metastases or history of leptomeningeal metastases. * Patients who are on systemic steroid therapy \> 10 mg/day of prednisone or other steroid equivalent. Patients receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg/day of prednisone or other steroid equivalent may be eligible. * Patients who are pregnant or breastfeeding. * Patients who have an active medical illness(es), which in the opinion of the Investigator, would pose increased risks for study participation * Cohort 1A, 1D, 2A, 3A, 3C, 3D and 3E patients may not have a medical history of autoimmune disorders (including pneumonitis) requiring treatment or active management. * Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment * Patients who have any form of primary immunodeficiency * Patients with a history of hypersensitivity to any component of the study drugs to be administered in the pertinent cohort(s). * Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association Class II or higher. A cardiac stress test demonstrating any irreversible wall movement abnormality in any patients ≥60 years of age or in patients who have a history of ischemic heart disease, cardiac chest pain, or clinically significant atrial and/or ventricular arrhythmias. * Patients with respiratory dysfunction or history of smoking are excluded if not meeting either of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \> 0.7 or FEV1 \> 50%. * Patients who have had another primary malignancy within the previous 3 years * Participation in another interventional clinical study within 21 days prior to the initiation of treatment. * Patients in Cohorts 1D, 3D, or 3E who previously received adjuvant or neoadjuvant ICI(s) for non-metastatic disease and had an immune-related AE(s) requiring systemic steroid treatment or discontinuation of immune checkpoint inhibitor therapy.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma melanoma metastatic melanoma non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Metastatic melanoma Non-small cell lung cancer Squamous cell carcinoma of the head and neck

Contacts and locations

Locations

  • Attikon University General Hospital

    Athens, Attica, 12461, Greece

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011, Switzerland

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Guy's Hospital

    London, England, SE19RT, United Kingdom

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, Málaga, 29016, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Laiko General Hospital of Athens

    Athens, Attica, 11527, Greece

  • MD Anderson at Cooper

    Camden, New Jersey, 08103, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Ohio State University

    Columbus, Ohio, 43201, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32610, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C1, Canada

  • The Royal Marsden NHS Foundation Trust

    London, England, SW3 6JJ, United Kingdom

  • Universitaetsspital Bern

    Bern, 3010, Switzerland

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, San Diego

    La Jolla, California, 92093, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Colorado

    Denver, Colorado, 80045, United States

  • University of Louisville

    Louisville, Kentucky, 40292, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Southern California

    Los Angeles, California, 90007, United States

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.