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Efficacy & Safety for LN144 With Pembrolizumab With High Risk Stage IIIb-dResectable Melanoma

Stage IIIC Melanoma Clinical Trial

Official title:
A Phase I Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN144) With Adjuvant Pembrolizumab for Treatment of Immunotherapy Naïve Patients With High Risk Stage IIIb-dResectable Melanoma

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

Clinical Trial Details
NCT number NCT06190249
Study type Interventional
Source Case Comprehensive Cancer Center
Contact James Isaacs, MD
Phone 1-866-223 8100
Email TaussigResearch@ccf.org
Status Not yet recruiting
Phase Phase 1
Start date June 1, 2024
Completion date July 2028
View Details
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