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Study identifier: NCT05727904 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Metastatic Melanoma · Unresectable Melanoma · Melanoma  ·  Sponsor: Iovance Biotherapeutics, Inc.

PhasePhase 3
Planned participants670
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Iovance Biotherapeutics https://www.tilvance-301.com  ·  1-844-845-4682  ·  Clinical.Inquiries@iovance.com

Iovance Biotherapeutics Study Team  ·  1-844-845-4682  ·  Clinical.Inquiries@iovance.com

Always discuss trial participation with your own doctor first.

Locations (81)

University of Alabama at Birmingham: The Kirklin ClinicBirmingham, Alabama, United StatesRecruiting
City of HopeDuarte, California, United StatesRecruiting
USC Norris Comprehensive Cancer CenterLos Angeles, California, United StatesRecruiting
California Pacific Medical CenterSan Francisco, California, United StatesRecruiting
University of Colorado Cancer CenterAurora, Colorado, United StatesRecruiting
Orlando Health Cancer InstituteOrlando, Florida, United StatesRecruiting
University of Illinois Hospital & Health Sciences SystemChicago, Illinois, United StatesWithdrawn
University of KansasKansas City, Kansas, United StatesWithdrawn
University of Louisville - James Graham Brown Cancer CenterLouisville, Kentucky, United StatesWithdrawn
National Cancer InstituteBethesda, Maryland, United StatesRecruiting
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer CenterDetroit, Michigan, United StatesWithdrawn
Henry Ford HealthDetroit, Michigan, United StatesRecruiting

+ 69 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05727904