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ACTIVE NOT RECRUITING
NCT05176470
PHASE1

Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

Sponsor: Richard Wu

View on ClinicalTrials.gov

Summary

This phase I/II trial tests the safety and side effects of LN-144 (Lifileucel) and pembrolizumab in treating patients with stage IIIB-D or stage IV melanoma that has spread to nearby tissue or lymph nodes. Biological therapies, such as LN-144 (Lifileucel), use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.

Official title: A Phase IB Study to Assess the Safety and Efficacy of Neoadjuvant Administration of Autologous Tumor Infiltrating Lymphocytes (LN144/Lifileucel) and Pembrolizumab for Treatment of Patients With Locally Advanced (Stage IIIB-D)/Metastatic (Stage IV) Melanoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

2

Start Date

2022-07-01

Completion Date

2026-12-31

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

BIOLOGICAL

Lifileucel

Given by IV infusion

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States