drugset / Trial / NCT02379195

Peginterferon and TIL Therapy for Metastatic Melanoma

NCT02379195

Phase 1/2 Completed 12 enrolled Inge Marie Svane
NaSingle-groupOpen-labelTreatment

Summary

Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from the patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 are administered to support T cell activation and proliferation in vivo. In this trial the therapy is combined with peginterferon (the pegylated form of interferon alpha 2b). Interferon alpha has immunomodulatory effects and is known to upregulate HLA expression on melanoma cells and are hypothesized to synergize with TIL therapy.

Timeline

Start
2014-11
Primary completion
2018-01
Completion
2018-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 3 ug/kg Subcutaneous
Subject TIL infusion Cell therapy
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background aldesleukin Protein / enzyme biologic 4.5 unknown Intravenous
Background aldesleukin Protein / enzyme biologic 18 unknown Intravenous

Indications