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Efficacy & Safety for LN144 With Pembrolizumab With High Risk Stage IIIb-dResectable Melanoma | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

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

NCT06190249•James Isaacs, MD

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must have a confirmed diagnosis of resectable, Stage III, High-Risk melanoma defined by AJCC v8 as Stage IIIB, IIIC, or IIID.
•Disease must be resected to no evidence of disease on imaging and no gross disease residually with the exception of positive microscopic margin. No prior treatment with immunotherapy.
•One (1) lesion at least 1.5cm in size (solitary or aggregate) available for TIL harvesting that has not undergone prior embolization or RT in prior 3 months unless subsequent growth is demonstrated.
•Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v 5.0
•Previous surgical procedure(s) is/are permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection.
•Patients must have a washout period ≥ 21 days from prior anti-cancer therapy(ies) to the start of the planned NMA-LD pre-conditioning regimen.
•Patients must be ≥ 18 years of age at the time of consent.
•Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months in the opinion of the Investigator.
•Patients must have the following hematologic parameters:• Absolute neutrophil count (ANC) ≥ 1000/mm3, •Hemoglobin (Hb) ≥ 9.0 g/dL, •Platelet ≥ 100,000/mm3
•Patients must have adequate organ function: •Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (≤ 3 × ULN); patients with liver metastasis ≤ 5 × ULN, •Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula at Screening, •Total bilirubin ≤ 2 mg/dL, •Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg/dL
+3 more criteria

Exclusion Criteria

•Patients who have received an organ allograft or prior cell transfer therapy within the past 20 years that included a non-myeloablative or myeloablative chemotherapy regimen.
•Patients with melanoma of uveal/ocular origin.
•Patients who have a history of hypersensitivity to any component or excipient of LN-144 or other study drugs:
•* NMA-LD preparative regimen (cyclophosphamide, mesna, and fludarabine),
•* Proleukin®, aldesleukin, IL-2,
•* Pembrolizumab,
•* Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity,
•* Any component of the LN-144 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.
•Patients with symptomatic and/or untreated brain metastases (of any size and any number).
•Patients who are on chronic systemic steroid therapy except for those requiring steroid therapy for management of adrenal insufficiency; these patients may receive no more than 10 mg of prednisone or its equivalent daily.
+12 more criteria

Key Dates

Start Date

December 2, 2024

Primary Completion Date

January 1, 2028

Completion Date

July 1, 2028

Last Updated

June 5, 2025

Conditions

Stage IIIB MelanomaStage IIIC MelanomaStage IIID Melanoma

Interventions

LN-144

BIOLOGICAL

Cyclophosphamide

DRUG

Mesna

DRUG

Fludarabine

DRUG

Interleukin-2 (IL-2)

BIOLOGICAL

Pembrolizumab

DRUG

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Stage IIIC MelanomaStage IV Melanoma

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COMPLETEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma

Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma

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