Actively Recruiting
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Led by Iovance Biotherapeutics, Inc. · Updated on 2026-04-03
670
Participants Needed
75
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or pathologically confirmed Stage IIIC, IIID, or IV unresectable or metastatic melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with life expectancy over 6 months
- At least one resectable lesion (or combined lesions) available for lifileucel preparation
- At least one measurable disease site as defined by RECIST 1.1 after tumor resection
- Adequate organ function
- Willingness to use highly effective birth control if of childbearing potential or having a partner of childbearing potential
- Participants over 70 years may enroll after discussion with medical monitor
You will not qualify if you...
- Melanoma of uveal/ocular origin
- Symptomatic untreated brain metastases
- More than one prior line of therapy for metastatic disease
- Prior therapy for metastatic disease
- BRAF V600 mutation-positive tumors with prior adjuvant/neoadjuvant immune checkpoint inhibitor therapy only
- Active major medical illnesses posing increased risk, such as systemic infections, seizure or coagulation disorders, or serious cardiovascular, respiratory, or immune conditions
- Any primary or acquired immunodeficiency (e.g., SCID or AIDS)
- Another primary malignancy within the past 3 years, except those not requiring treatment or curatively treated over 1 year ago with low recurrence risk
- History of allogeneic cell or organ transplant
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 75 locations
1
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90007
Actively Recruiting
4
California Pacific Medical Center
San Francisco, California, United States, 94107
Actively Recruiting
5
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Actively Recruiting
7
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States, 60612
Withdrawn
8
University of Kansas
Kansas City, Kansas, United States, 66205
Withdrawn
9
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Withdrawn
10
National Cancer Institute
Bethesda, Maryland, United States, 20814
Actively Recruiting
11
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Withdrawn
12
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
13
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
14
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States, 08103
Actively Recruiting
15
Oncology Hematology Care
Cincinnati, Ohio, United States, 45226
Actively Recruiting
16
Ohio State University
Columbus, Ohio, United States, 43201
Actively Recruiting
17
St. Luke's Cancer Center - Anderson
Easton, Pennsylvania, United States, 18045
Withdrawn
18
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
19
Baptist Cancer Center
Bartlett, Tennessee, United States, 37920
Actively Recruiting
20
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
21
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Withdrawn
22
Swedish Cancer Institute
Edmonds, Washington, United States, 98026
Actively Recruiting
23
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Actively Recruiting
24
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
25
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
26
Flinders Medical Centre
Bedford Park, Australia, 5042
Actively Recruiting
27
Westmead Hospital
Westmead, Australia, NSW 2145
Actively Recruiting
28
Universitair Ziekenhuis Brussel - Oncologisch Centrum
Jette, Belgium
Actively Recruiting
29
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2L 4M1
Actively Recruiting
30
Princess Margaret Cancer Centre
Toronto, Canada, M5G
Actively Recruiting
31
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
32
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes, France, 44093
Actively Recruiting
33
Hopital Saint Louis
Paris, France, 75475
Actively Recruiting
34
Charité - Universitätsmedizin Berlin
Berlin, Germany, Germany, 13353
Actively Recruiting
35
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 1307
Actively Recruiting
36
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
37
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Germany, 23562
Actively Recruiting
38
Klinikum Rechts der Isar der Technischen Universität München
Munich, Germany, 81675
Actively Recruiting
39
Hadassah Medical Center
Jerusalem, Israel
Actively Recruiting
40
Sheba Medical Center
Ramat Gan, Israel, 52621
Actively Recruiting
41
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
42
Istituto Romagnolo per lo Studio dei Tumori
Meldola, Forlì-Cesena, Italy, 47014
Actively Recruiting
43
Centro di Riferimento Oncologico IRCCS
Aviano, Friuli Venezia Giulia, Italy, 33081
Actively Recruiting
44
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Naples, Napoli, Italy, 80131
Actively Recruiting
45
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy, 56100
Actively Recruiting
46
Istituto Europeo Di Oncologia
Milan, Italy, 20139
Withdrawn
47
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Actively Recruiting
48
Nederlands Kanker Instituut
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
49
Bundang Medical Center - CHA University
Seongnam-si, Gyeonggi-do, South Korea
Actively Recruiting
50
Samsung Medical Center
Seoul, South Korea, South Korea, 135-890
Actively Recruiting
51
Korea University Anam Hospital
Seoul, South Korea, 2841
Actively Recruiting
52
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
53
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 3722
Actively Recruiting
54
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
55
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga, Spain, 29016
Actively Recruiting
56
Instituto Oncologico Rosell
Barcelona, Spain, 08028
Actively Recruiting
57
Hospital Universitari Vall dHebron
Barcelona, Spain, 08035
Withdrawn
58
Hospital Clinic de Barcelona
Barcelona, Spain, 8036
Actively Recruiting
59
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 8908
Actively Recruiting
60
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
61
Hospital 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
62
Hospital Universitario Madrid Sanchinarro - CIOCC
Madrid, Spain, 28050
Actively Recruiting
63
Hospital Universitario Quirónsalud Madrid
Madrid, Spain, 28223
Actively Recruiting
64
Hospital Universitario Ramon y Cajal
Madrid, Spain
Actively Recruiting
65
Clínica Universitaria de Navarra
Pamplona, Spain, 31008
Actively Recruiting
66
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
67
Consorcio Hospital General Universitario de Valencia
Valencia, Spain, 46014
Actively Recruiting
68
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, Sweden, SE-41346
Actively Recruiting
69
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, Switzerland, 1011
Actively Recruiting
70
Queen Elizabeth Hospital Birmingham
Birmingham, England, United Kingdom, B15 2GW
Actively Recruiting
71
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom, NE7 7DN
Actively Recruiting
72
Royal Marsden Hospital
Chelsea, London, United Kingdom, SW3 6JJ
Actively Recruiting
73
Beaston West of Scotland Canter Centre
Glasgow, United Kingdom, G120YN
Actively Recruiting
74
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
75
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
Actively Recruiting
Research Team
I
Iovance Biotherapeutics https://www.tilvance-301.com
CONTACT
I
Iovance Biotherapeutics Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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