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

NCT06190249 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-06-05

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Iovance Biotherapeutics, Inc.

    collaborator INDUSTRY

  • James Isaacs, MD

    lead OTHER

Principal Investigators

  • James Isaacs, MD · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2028-01-31
Completion
2028-07-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190249 on ClinicalTrials.gov