drugset / Trial / NCT05176470

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

NCT05176470

Phase 1 Active not recruiting 2 enrolled Richard Wu Iovance Biotherapeutics, Inc. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-07-01
Primary completion
2023-07-14
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody Intravenous
Subject Tumor Infiltrating Lymphocytes Cell therapy Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous

Indications