At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 220 enrolled
Drug / intervention
Lifileucelbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating Lifileucel for Metastatic Melanoma. Completed, enrolled 220 participants across 57 sites in 8 countries.
Detailed Summary
Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Melanoma
CountriesFrance, Germany, Hungary, Italy, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartSep 2015
Primary CompletionOct 2024
TodayJul 2026
First PostedFeb 10, 2015
Enrollment StartSep 24, 2015
Primary CompletionOct 24, 2024
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 11.4 years ago
Interventions
Lifileucelbiological
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2.