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Supercharged immune cells take on advanced melanoma in major new trial

NCT ID NCT05727904

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial is testing whether a powerful combination of two treatments works better than standard immunotherapy alone for people with advanced melanoma that has not been treated yet. The experimental approach uses lifileucel, a personalized therapy made from a patient's own tumor-fighting immune cells, given together with the immunotherapy drug pembrolizumab. About 670 participants will be randomly assigned to receive either the combination or pembrolizumab alone, with the goal of seeing which group has better tumor shrinkage and longer time without cancer growth.

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 tumor-fighting immune cells) plus pembrolizumab (an immunotherapy drug)
What this could lead to
If successful, this combination could offer a more effective first-line treatment for advanced melanoma, potentially shrinking tumors and delaying progression better than standard immunotherapy alone.
What could go wrong
This is an early Phase 3 trial, so results are not yet proven. The cell therapy requires surgery and a complex manufacturing process, and side effects from lymphodepletion and IL-2 can be severe. Not all patients may benefit.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 670 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Mar 2030

An estimate. End dates often move.

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 to 70 years

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: 1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma. 2. In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \> 6 months. 3. Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation. 4. Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection. 5. Participants must have adequate organ function. 6. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control. 7. Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor. Exclusion Criteria: 1. Participant has melanoma of uveal/ocular origin. 2. Participant has symptomatic untreated brain metastases. 3. Participant received more than 1 prior line of therapy. 4. Participant received prior therapy for metastatic disease 5. Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only 6. Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems. 7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS). 8. Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.) 9. Participant has a history of allogeneic cell or organ transplant. Other protocol defined inclusion/exclusion criteria could apply.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma skin neoplasm

As listed by the trial registrant

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

Melanoma Metastatic melanoma Unresectable melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    73 sites in 16 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Allegheny Health Network

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Azienda Ospedaliera Universitaria Senese

    RECRUITING

    Siena, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, Tuscany, 56100, Italy

  • Baptist Cancer Center

    RECRUITING

    Bartlett, Tennessee, 37920, United States

  • Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

    WITHDRAWN

    Detroit, Michigan, 48201, United States

  • Beaston West of Scotland Canter Centre

    RECRUITING

    Glasgow, G120YN, United Kingdom

  • Bundang Medical Center - CHA University

    RECRUITING

    Seongnam-si, Gyeonggi-do, South Korea

  • California Pacific Medical Center

    RECRUITING

    San Francisco, California, 94107, United States

  • Centre Hospitalier Universitaire Vaudois Lausanne

    RECRUITING

    Lausanne, 1011, Switzerland

  • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu

    RECRUITING

    Nantes, 44093, France

  • Centre hospitalier de l'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2L 4M1, Canada

  • Centro di Riferimento Oncologico IRCCS

    RECRUITING

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, Germany, 13353, Germany

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Clínica Universitaria de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Consorcio Hospital General Universitario de Valencia

    RECRUITING

    Valencia, 46014, Spain

  • Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, 5042, Australia

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, England, NE7 7DN, United Kingdom

  • Greenslopes Private Hospital

    RECRUITING

    Greenslopes, Queensland, 4120, Australia

  • Guy's Hospital

    RECRUITING

    London, SE1 9RT, United Kingdom

  • HM Centro Integral Oncologico Clara Campal

    RECRUITING

    Madrid, Spain, 28050, Spain

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, Israel

  • Helsinki University Hospital Comprehensive Cancer Center

    RECRUITING

    Helsinki, Finland, 290, Finland

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hopital Saint Louis

    RECRUITING

    Paris, 75475, France

  • Hospital 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 8036, Spain

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga - Hospital General

    RECRUITING

    Málaga, Málaga, 29016, Spain

  • Hospital Universitari Vall dHebron

    WITHDRAWN

    Barcelona, 08035, Spain

  • Hospital Universitario Madrid Sanchinarro - CIOCC

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario Marques de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Quirónsalud Madrid

    RECRUITING

    Madrid, 28223, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    RECRUITING

    Barcelona, 8908, Spain

  • Institut Català d'Oncologia (ICO)

    RECRUITING

    Barcelona, Spain, 8908, Spain

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

  • Instituto Oncologico Rosell

    RECRUITING

    Barcelona, 08028, Spain

  • Intermountain Health

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Istituto Europeo Di Oncologia

    WITHDRAWN

    Milan, 20139, Italy

  • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

    RECRUITING

    Naples, Napoli, 80131, Italy

  • Istituto Romagnolo per lo Studio dei Tumori

    RECRUITING

    Meldola, Forlì-Cesena, 47014, Italy

  • Klinikum Rechts der Isar der Technischen Universität München

    RECRUITING

    Munich, 81675, Germany

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 2841, South Korea

  • MD Anderson Cancer Center at Cooper

    RECRUITING

    Camden, New Jersey, 08103, United States

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, Singapore, 168582, Singapore

  • National Cancer Institute

    RECRUITING

    Bethesda, Maryland, 20814, United States

  • Nederlands Kanker Instituut

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43201, United States

  • Oncology Hematology Care

    RECRUITING

    Cincinnati, Ohio, 45226, United States

  • Orlando Health Cancer Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, M5G, Canada

  • Queen Elizabeth Hospital Birmingham

    RECRUITING

    Birmingham, England, B15 2GW, United Kingdom

  • Royal Marsden Hospital

    RECRUITING

    Chelsea, London, SW3 6JJ, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sahlgrenska Universitetssjukhuset

    RECRUITING

    Gothenburg, Västra Götaland County, SE-41346, Sweden

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea, 135-890, South Korea

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Seoul National University Hospital

    RECRUITING

    Seoul, 3080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 3722, South Korea

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 52621, Israel

  • St. Luke's Cancer Center - Anderson

    WITHDRAWN

    Easton, Pennsylvania, 18045, United States

  • Swedish Cancer Institute

    RECRUITING

    Edmonds, Washington, 98026, United States

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90007, United States

  • Universitair Ziekenhuis Brussel - Oncologisch Centrum

    RECRUITING

    Jette, Belgium

  • University of Alabama at Birmingham: The Kirklin Clinic

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Illinois Hospital & Health Sciences System

    WITHDRAWN

    Chicago, Illinois, 60612, United States

  • University of Kansas

    WITHDRAWN

    Kansas City, Kansas, 66205, United States

  • University of Louisville - James Graham Brown Cancer Center

    WITHDRAWN

    Louisville, Kentucky, 40202, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Universitätsklinikum Carl Gustav Carus

    RECRUITING

    Dresden, 1307, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20251, Germany

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    RECRUITING

    Lübeck, 23562, Germany

  • Virginia Commonwealth University

    WITHDRAWN

    Richmond, Virginia, 23298, United States

  • Westmead Hospital

    RECRUITING

    Westmead, NSW 2145, Australia

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