drugset / Trial / NCT04142931

Sequentional Immuno Apheresis Plasma Volume Escalation Cohort Study of Reduction of Soluble Tumor Necrosis Factor Receptors 1 and 2 (sTNFR1/2) With or Without Nivolumab in Patients With Inoperable or Metastatic Solid Tumors

NCT04142931 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

Sequential immune apheresis plasma volume escalation cohort study of reduction of soluble Tumor Necrosis Factors Receptors 1/2 (sTNFR1/2), with or without Nivolumab, in patients with inoperable or metastatic solid Tumors. This study evaluates Immunicom fs LW-02 device used with Spectra Optia apheresis system, aiming to answer two different study questions: * Safety, tolerability and effectiveness of the device. * Safety, tolerability and effectiveness of the device, employed as monotherapy, or combined with Nivolumab.

Timeline

Start
2020-02-24
Primary completion
2021-12-30
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 240 mg Intravenous