Boosting Treatment for Advanced Melanoma with Lifileucel and Pembrolizumab
NCT05727904 · RecruitingThis study looks at how effective and safe the combination of lifileucel and pembrolizumab is for treating advanced melanoma. Participants will be compared to those receiving only pembrolizumab. The trial focuses on people with untreated, unresectable, or metastatic melanoma, which means the cancer cannot be removed by surgery or has spread to other parts of the body.
Locations and contact
This trial is running at 75 locations. The first 8 are listed here.
- University of Alabama at Birmingham: The Kirklin ClinicBirmingham, AlabamaRecruiting
- City of HopeDuarte, CaliforniaRecruiting
- USC Norris Comprehensive Cancer CenterLos Angeles, CaliforniaRecruiting
- California Pacific Medical CenterSan Francisco, CaliforniaRecruiting
- University of Colorado Cancer CenterAurora, ColoradoRecruiting
- Orlando Health Cancer InstituteOrlando, FloridaRecruiting
- University of Illinois Hospital & Health Sciences SystemChicago, IllinoisWithdrawn
- University of KansasKansas City, KansasWithdrawn
Who can join
This trial welcomes adults aged 18 to 70, both men and women, who have been diagnosed with advanced melanoma that cannot be removed by surgery. Participants must be healthy enough for treatment and can have had some previous therapy, but not more than one. The trial team will confirm eligibility before enrollment.
What happens during the trial
Participants are randomly divided into two groups. One group receives lifileucel and pembrolizumab together. The other group receives pembrolizumab alone. Those who receive pembrolizumab may switch to lifileucel if their condition worsens. Each participant's tumor will be used to develop lifileucel before treatment begins.
The trial team
The trial is sponsored by Iovance Biotherapeutics, Inc. The Iovance Biotherapeutics Study Team leads the study.
Important dates
The trial began on March 30, 2023, and is expected to be completed by March 1, 2030. It is currently enrolling new participants.
Additional information
The trial's ID number is NCT05727904. This is a Phase 3 trial, which means it looks at how well the treatment works and checks its safety. The study aims to include about 670 participants and is regulated by the FDA.
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