NCT06190249

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: James Isaacs, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Stage IIIB Melanoma
• Stage IIIC Melanoma
• Stage IIID Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	LN-144	A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-144), followed by IL-2.
DRUG	Cyclophosphamide	Given by IV.
DRUG	Mesna	Given by IV.
DRUG	Fludarabine	Given by IV.
BIOLOGICAL	Interleukin-2 (IL-2)	Given by IV.
DRUG	Pembrolizumab	Given by IV.

Timeline

• Start date: 2024-12-02
• Primary completion: 2028-01-01
• Completion: 2028-07-01
• First posted: 2024-01-05
• Last updated: 2025-06-05

Regulatory

• FDA-regulated drug study