Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
NCT ID: NCT05727904
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
670 participants
INTERVENTIONAL
2023-03-30
2030-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Lifileucel plus Pembrolizumab
Lifileucel plus Pembrolizumab
A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive Pembrolizumab followed by the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. Patients will then continue to receive Pembrolizumab every 6 weeks until disease progression.
Arm B
Pembrolizumab alone with Optional Crossover Period
Pembrolizumab with Optional Crossover Period
Patient will receive Pembrolizumab monotherapy every 6 weeks until disease progression. Upon verified confirmed disease progression by the blinded independent review central committee, patients may proceed to lifileucel monotherapy during an optional crossover period if they meet eligibility criteria.
Optional crossover: A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2.
Interventions
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Lifileucel plus Pembrolizumab
A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive Pembrolizumab followed by the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. Patients will then continue to receive Pembrolizumab every 6 weeks until disease progression.
Pembrolizumab with Optional Crossover Period
Patient will receive Pembrolizumab monotherapy every 6 weeks until disease progression. Upon verified confirmed disease progression by the blinded independent review central committee, patients may proceed to lifileucel monotherapy during an optional crossover period if they meet eligibility criteria.
Optional crossover: A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Iovance Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Iovance Biotherapeutics Study Team
Role: STUDY_DIRECTOR
Iovance Biotherapeutics
Locations
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University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
National Cancer Institute
Bethesda, Maryland, United States
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
St. Luke's Cancer Center - Anderson
Easton, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Baptist Cancer Center
Bartlett, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Cancer Institute
Edmonds, Washington, United States
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Flinders Medical Centre
Bedford Park, , Australia
Westmead Hospital
Westmead, , Australia
Universitair Ziekenhuis Brussel - Oncologisch Centrum
Jette, , Belgium
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Princess Margaret Cancer Centre
Toronto, , Canada
Institut Paoli Calmettes
Marseille, , France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, , France
Hopital Saint Louis
Paris, , France
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, , Germany
Klinikum Rechts der Isar der Technischen Universität München
Munich, , Germany
Hadassah Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Istituto Romagnolo per lo Studio dei Tumori
Meldola, Forlì-Cesena, Italy
Centro di Riferimento Oncologico IRCCS
Aviano, Friuli Venezia Giulia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Nederlands Kanker Instituut
Amsterdam, , Netherlands
Bundang Medical Center - CHA University
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga, Spain
Instituto Oncologico Rosell
Barcelona, , Spain
Hospital Universitari Vall dHebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario Madrid Sanchinarro - CIOCC
Madrid, , Spain
Hospital Universitario Quirónsalud Madrid
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Clínica Universitaria de Navarra
Pamplona, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, Sweden
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, , Switzerland
Queen Elizabeth Hospital Birmingham
Birmingham, England, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom
Royal Marsden Hospital
Chelsea, London, United Kingdom
Beaston West of Scotland Canter Centre
Glasgow, , United Kingdom
Guy's Hospital
London, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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TILVANCE-301
Identifier Type: OTHER
Identifier Source: secondary_id
TILVANCE
Identifier Type: OTHER
Identifier Source: secondary_id
IOV-MEL-301
Identifier Type: -
Identifier Source: org_study_id
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