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

NCT05727904 · Iovance Biotherapeutics, Inc.
In plain English

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Official title
A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 670 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-03-30
Estimated completion: 2030-03-01
Last updated: 2026-04-03
Interventions
Biological: Lifileucel plus PembrolizumabBiological: Pembrolizumab with Optional Crossover Period
Primary outcomes
  • Objective Response Rate and Progression Free Survival (5 years total duration)
Sponsor
Iovance Biotherapeutics, Inc. · industry
Contacts & investigators
ContactIovance Biotherapeutics https://www.tilvance-301.com · contact · Clinical.Inquiries@iovance.com · 1-844-845-4682
ContactIovance Biotherapeutics Study Team · contact · Clinical.Inquiries@iovance.com · 1-844-845-4682
InvestigatorIovance Biotherapeutics Study Team · study_director, Iovance Biotherapeutics
All locations (75)
University of Alabama at Birmingham: The Kirklin ClinicRecruiting
Birmingham, Alabama, United States
City of HopeRecruiting
Duarte, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
California Pacific Medical CenterRecruiting
San Francisco, California, United States
University of Colorado Cancer CenterRecruiting
Aurora, Colorado, United States
Orlando Health Cancer InstituteRecruiting
Orlando, Florida, United States
University of Illinois Hospital & Health Sciences SystemWithdrawn
Chicago, Illinois, United States
University of KansasWithdrawn
Kansas City, Kansas, United States
University of Louisville - James Graham Brown Cancer CenterWithdrawn
Louisville, Kentucky, United States
National Cancer InstituteRecruiting
Bethesda, Maryland, United States
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer CenterWithdrawn
Detroit, Michigan, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer CenterRecruiting
Lebanon, New Hampshire, United States
MD Anderson Cancer Center at CooperRecruiting
Camden, New Jersey, United States
Oncology Hematology CareRecruiting
Cincinnati, Ohio, United States
Ohio State UniversityRecruiting
Columbus, Ohio, United States
St. Luke's Cancer Center - AndersonWithdrawn
Easton, Pennsylvania, United States
Allegheny Health NetworkRecruiting
Pittsburgh, Pennsylvania, United States
Baptist Cancer CenterRecruiting
Bartlett, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Virginia Commonwealth UniversityWithdrawn
Richmond, Virginia, United States
Swedish Cancer InstituteRecruiting
Edmonds, Washington, United States
Greenslopes Private HospitalRecruiting
Greenslopes, Queensland, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Fiona Stanley HospitalRecruiting
Murdoch, Western Australia, Australia
Flinders Medical CentreRecruiting
Bedford Park, Australia
Westmead HospitalRecruiting
Westmead, Australia
Universitair Ziekenhuis Brussel - Oncologisch CentrumRecruiting
Jette, Belgium
Centre hospitalier de l'Université de MontréalRecruiting
Montreal, Quebec, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Canada
Institut Paoli CalmettesRecruiting
Marseille, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-DieuRecruiting
Nantes, France
Hopital Saint LouisRecruiting
Paris, France
Charité - Universitätsmedizin BerlinRecruiting
Berlin, Germany, Germany
Universitätsklinikum Carl Gustav CarusRecruiting
Dresden, Germany
Universitätsklinikum Hamburg-EppendorfRecruiting
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein - Campus LübeckRecruiting
Lübeck, Germany
Klinikum Rechts der Isar der Technischen Universität MünchenRecruiting
Munich, Germany
Hadassah Medical CenterRecruiting
Jerusalem, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Istituto Romagnolo per lo Studio dei TumoriRecruiting
Meldola, Forlì-Cesena, Italy
Centro di Riferimento Oncologico IRCCSRecruiting
Aviano, Friuli Venezia Giulia, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni PascaleRecruiting
Naples, Napoli, Italy
Azienda Ospedaliero Universitaria PisanaRecruiting
Pisa, Tuscany, Italy
Istituto Europeo Di OncologiaWithdrawn
Milan, Italy
Azienda Ospedaliera Universitaria SeneseRecruiting
Siena, Italy
Nederlands Kanker InstituutRecruiting
Amsterdam, Netherlands
Bundang Medical Center - CHA UniversityRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea, South Korea
Korea University Anam HospitalRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Hospital Universitario Marques de ValdecillaRecruiting
Santander, Cantabria, Spain
Hospital Regional Universitario de Malaga - Hospital GeneralRecruiting
Málaga, Málaga, Spain
Instituto Oncologico RosellRecruiting
Barcelona, Spain
Hospital Universitari Vall dHebronWithdrawn
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i ReynalsRecruiting
Barcelona, Spain
Hospital General Universitario Gregorio MaranonRecruiting
Madrid, Spain
Hospital 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario Madrid Sanchinarro - CIOCCRecruiting
Madrid, Spain
Hospital Universitario Quirónsalud MadridRecruiting
Madrid, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Clínica Universitaria de NavarraRecruiting
Pamplona, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Consorcio Hospital General Universitario de ValenciaRecruiting
Valencia, Spain
Sahlgrenska UniversitetssjukhusetRecruiting
Gothenburg, Västra Götaland County, Sweden
Centre Hospitalier Universitaire Vaudois LausanneRecruiting
Lausanne, Switzerland
Queen Elizabeth Hospital BirminghamRecruiting
Birmingham, England, United Kingdom
Freeman HospitalRecruiting
Newcastle upon Tyne, England, United Kingdom
Royal Marsden HospitalRecruiting
Chelsea, London, United Kingdom
Beaston West of Scotland Canter CentreRecruiting
Glasgow, United Kingdom
Guy's HospitalRecruiting
London, United Kingdom
Sarah Cannon Research Institute UKRecruiting
London, United Kingdom
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. · TrialPath