About this trial
This 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.
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.
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.
Conditions
Metastatic Melanoma, Unresectable Melanoma, Melanoma
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
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.
Where
This trial is running at 24 locations in the United States. 18 of them are currently recruiting.
Allegheny Health Network
Pittsburgh, Pennsylvania
Baptist Cancer Center
Bartlett, Tennessee
California Pacific Medical Center
San Francisco, California
City of Hope
Duarte, California
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
Lebanon, New Hampshire
Henry Ford Health
Detroit, Michigan
Intermountain Health
Salt Lake City, Utah
MD Anderson Cancer Center at Cooper
Camden, New Jersey
The first 8 of 24 sites are listed here. The registry record has the full list.