Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

Last updated: April 18, 2025
Sponsor: Iovance Biotherapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Metastatic Melanoma

Melanoma

Treatment

Lifileucel plus Pembrolizumab

Pembrolizumab with Optional Crossover Period

Clinical Study ID

NCT05727904
IOV-MEL-301
TILVANCE-301
TILVANCE
  • Ages 18-70
  • All Genders

Study Summary

This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant has a histologically or pathologically confirmed diagnosis of StageIIIC, IIID, or IV unresectable or metastatic melanoma.

  2. In the investigator's assessment, the participant has an Eastern CooperativeOncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancyof > 6 months.

  3. Participant is assessed as having at least one resectable lesion (or aggregatelesions) for lifileucel generation.

  4. Participant must have at least one measurable disease as defined by RECIST 1.1following tumor resection.

  5. Participants must have adequate organ function.

  6. Participants of childbearing potential or those with partners of childbearingpotential must be willing to practice an approved method of highly effective birthcontrol.

  7. Participants who are > 70 years of age may be allowed to enroll after theinvestigator discusses with the medical monitor.

Exclusion

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 prioradjuvant/neoadjuvant ICI therapy only

  6. Participant has an active medical illness(es) that, in the opinion of theinvestigator, would pose increased risks for study participation, such as systemicinfections; seizure disorders; coagulation disorders; or other active major medicalillnesses 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 forthose that do not require treatment or were curatively treated >1 year ago, and inthe 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.

Study Design

Total Participants: 670
Treatment Group(s): 2
Primary Treatment: Lifileucel plus Pembrolizumab
Phase: 3
Study Start date:
March 30, 2023
Estimated Completion Date:
March 01, 2030

Study Description

The study will enroll participants with unresectable or metastatic melanoma (Stage IIIC, IIID, or IV per the American Joint Committee on Cancer [AJCC] staging system) who have had no prior therapy for metastatic disease. Previous adjuvant/neoadjuvant therapy with a single line of protooncogene B-Raf (BRAF) inhibitor with or without a mitogen-activated protein kinase (MEK) inhibitor, PD-1 inhibitor, or cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4] inhibitor is allowed, provided such treatment was completed ≥6 months before progression to metastatic disease.

Connect with a study center

  • Greenslopes Private Hospital

    Greenslopes, Queensland 4120
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, NSW 2145
    Australia

    Active - Recruiting

  • Universitair Ziekenhuis Brussel - Oncologisch Centrum

    Jette,
    Belgium

    Active - Recruiting

  • Centre hospitalier de l'Université de Montréal

    Montréal, Quebec H2L 4M1
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, M5G
    Canada

    Active - Recruiting

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

    Nantes, 44093
    France

    Active - Recruiting

  • Hopital Saint Louis

    Paris, 75475
    France

    Active - Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20251
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, 23562
    Germany

    Active - Recruiting

  • Klinikum Rechts der Isar der Technischen Universität München

    Munich, 81675
    Germany

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem,
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori

    Meldola, Forlì-Cesena 47014
    Italy

    Active - Recruiting

  • Centro di Riferimento Oncologico IRCCS

    Aviano, Friuli-Venezia Giulia 33081
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Toscana 56100
    Italy

    Active - Recruiting

  • Istituto Europeo Di Oncologia

    Milan, 20139
    Italy

    Active - Recruiting

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

    Napoli, 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Senese

    Siena,
    Italy

    Active - Recruiting

  • Bundang Medical Center - CHA University

    Seongnam-si, Gyeonggi-do
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 3080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722
    Korea, Republic of

    Active - Recruiting

  • Nederlands Kanker Instituut

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga - Hospital General

    Malaga, Málaga 29016
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall dHebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 8908
    Spain

    Active - Recruiting

  • Instituto Oncologico Rosell

    Barcelona, 08028
    Spain

    Active - Recruiting

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Madrid Sanchinarro - CIOCC

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Quirónsalud Madrid

    Madrid, 28223
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Clínica Universitaria de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset

    Göteborg, Vastra Gotalands Lan SE-41346
    Sweden

    Active - Recruiting

  • Centre Hospitalier Universitaire Vaudois Lausanne

    Lausanne, 1011
    Switzerland

    Active - Recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham, England B15 2GW
    United Kingdom

    Active - Recruiting

  • Freeman Hospital

    Newcastle upon Tyne, England NE7 7DN
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital

    Chelsea, London SW3 6JJ
    United Kingdom

    Active - Recruiting

  • Beaston West of Scotland Canter Centre

    Glasgow, G120YN
    United Kingdom

    Active - Recruiting

  • Guy's Hospital

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Sarah Cannon Research Institute UK

    London, W1G 6AD
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham: The Kirklin Clinic

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90007
    United States

    Active - Recruiting

  • California Pacific Medical Center

    San Francisco, California 94107
    United States

    Active - Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • University of Illinois Hospital & Health Sciences System

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Kansas

    Kansas City, Kansas 66205
    United States

    Active - Recruiting

  • University of Louisville - James Graham Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • National Cancer Institute

    Bethesda, Maryland 20814
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Active - Recruiting

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

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Oncology Hematology Care

    Cincinnati, Ohio 45226
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43201
    United States

    Active - Recruiting

  • St. Luke's Cancer Center - Anderson

    Easton, Pennsylvania 18045
    United States

    Active - Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Baptist Cancer Center

    Bartlett, Tennessee 37920
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Edmonds, Washington 98026
    United States

    Active - Recruiting

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