drugset / Trial / NCT03475134

TIL-ACT After NMA Chemo with IL-2 and Nivo Rescue in Metastatic Melanoma (mMEL)

NCT03475134 ↗

Phase 1 Completed 18 enrolled Centre Hospitalier Universitaire Vaudois
NaSingle-groupOpen-labelTreatment

Summary

This is a single center, single arm phase I trial to test the feasibility and safety of Tumor- Infiltrating Lymphocyte-Adoptive Cell Therapy (TIL-ACT) followed by nivolumab rescue in unresectable locally advanced or metastatic melanoma patients. The trial is based on lymphodepleting chemotherapy followed by ACT, utilizing ex vivo expanded TILs in combination with high dose interleukin-2 (IL-2) (optional, depending on patient's tolerance), followed by nivolumab rescue (if indicated) for a maximum duration of 2 years.

Timeline

Start
2018-02-21
Primary completion
2021-02-09
Completion
2024-06-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 240 mg —
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous
Background aldesleukin Protein / enzyme biologic — —

Indications