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TIL and Anti-PD1 in Metastatic Melanoma — ACTME  

Adverse Drug Event Clinical Trial

Official title:
Adoptive TIL Therapy With Low-dose IFN-alpha Plus Anti-PD1 in Metastatic Melanoma

Clinical Trial Summary

The ACTME study is an investigator initiated, single center phase I/II clinical trial for patients with progressive unresectable stage III or stage IV melanoma. The trial consists of both a phase I part to determine safety and feasibility and a phase II part to evaluate first clinical activity of IFN-alpha, nivolumab and TIL. The treatment with IFN-alpha will be added after the combination of TIL and nivolumab has proven to be safe.

Clinical Trial Description

The ACTME is an investigator initiated, single center phase I/II clinical trial for patients with progressive unresectable stage III or stage IV melanoma. Patients are conditioned by low-dose IFN-alpha and treated with ACT and PD-1 antibodies. With this approach the investigators hope to solve 4 of the most important aspects curtailing the efficacy of current immunotherapies in metastatic melanoma: 1. the lack of sufficient numbers of activated tumor-reactive T cells in patients by providing ACT; and 2. the inhibition of T-cell effector function through PD-1 signalling by administration of nivolumab; as well as 3. the toxicity of high-dose IL-2, and 4. long term hospitalization of patients due to the conditioning-regimen used in most ACT protocols by replacing it with low-dose IFN-alpha treatment. The trial consists of both a phase I part to determine safety and feasibility and a phase II part to evaluate first clinical activity of IFN-alpha, nivolumab and TIL. The treatment with IFN-alpha will be added after the combination of TIL and nivolumab has proven to be safe in the first cohort of the phase I part of the trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03638375
Study type Interventional
Source Leiden University Medical Center
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date July 31, 2018
Completion date November 29, 2025
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