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Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of adjuvant adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin-2 (IL-2) after a nonmyeloablative lymphodepletion (NMA-LD) preparative regimen, followed by Pembrolizumab.


Clinical Trial Description

Primary: • To evaluate the efficacy of LN-144 with adjuvant Pembrolizumab in Stage IIIb-d melanoma patients as assessed by 6 and 12-month relapse-free survival (RFS) Secondary: - To further evaluate the efficacy of LN-144 with adjuvant Pembrolizumab in Stage IIIb-d melanoma patients using overall survival (OS) and distant metastasis-free survival - To characterize the safety profile of LN-144 in Stage IIIb-d melanoma patients as measured by the incidence of Grade ≥ 3 treatment emergent adverse events (TEAEs) within 3 months of LN-144 administration - To identify location of relapse - Rate of achievable recruitment for duration of planned recruitment period ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06190249
Study type Interventional
Source Case Comprehensive Cancer Center
Contact
Status Suspended
Phase Phase 1
Start date June 30, 2024
Completion date July 2028

See also
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