Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Recruiting · NCT05727904 · Interventional (participants receive a specific treatment) · Lead sponsor: Iovance Biotherapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Lifileucel plus PembrolizumabPembrolizumab with Optional Crossover Period
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
- 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.
- Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
- Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
- Participants must have adequate organ function.
- Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
- Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion criteria
- Participant has melanoma of uveal/ocular origin.
- Participant has symptomatic untreated brain metastases.
- Participant received more than 1 prior line of therapy.
- Participant received prior therapy for metastatic disease
- Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
- 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.
- Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
- 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.)
- Participant has a history of allogeneic cell or organ transplant.
- ther protocol defined inclusion/exclusion criteria could apply.
Where it is running
60 locations listed across 18 US states.
- 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
- University of Minnesota - Minneapolis, Minnesota, 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
- Intermountain Health - Salt Lake City, Utah, United States
- Virginia Commonwealth University - Richmond, Virginia, United States
- Swedish Cancer Institute - Edmonds, Washington, United States
- Nederlands Kanker Instituut - Amsterdam, Netherlands
- 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
- Flinders Medical Centre - Bedford Park, Australia
- Universitätsklinikum Carl Gustav Carus - Dresden, Germany
- Beaston West of Scotland Canter Centre - Glasgow, United Kingdom
- Universitätsklinikum Hamburg-Eppendorf - Hamburg, Germany
- Hadassah Medical Center - Jerusalem, Israel
- Universitair Ziekenhuis Brussel - Oncologisch Centrum - Jette, Belgium
- Centre Hospitalier Universitaire Vaudois Lausanne - Lausanne, Switzerland
- Guy's Hospital - London, United Kingdom
- Sarah Cannon Research Institute UK - London, United Kingdom
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck - Lübeck, Germany
- 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
- Institut Paoli Calmettes - Marseille, France
- Istituto Europeo Di Oncologia - Milan, Italy
- Klinikum Rechts der Isar der Technischen Universität München - Munich, Germany
- Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu - Nantes, France
- Clínica Universitaria de Navarra - Pamplona, Spain
- Hopital Saint Louis - Paris, France
- Sheba Medical Center - Ramat Gan, Israel
- Korea University Anam Hospital - Seoul, South Korea
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital, Yonsei University Health System - Seoul, South Korea
- Hospital Universitario Virgen Macarena - Seville, Spain
- Azienda Ospedaliera Universitaria Senese - Siena, Italy
- Tel Aviv Sourasky Medical Center - Tel Aviv, Israel
- Princess Margaret Cancer Centre - Toronto, Canada
- Consorcio Hospital General Universitario de Valencia - Valencia, Spain
- Westmead Hospital - Westmead, Australia
Showing 60 of 81 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →