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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

Triple Negative Breast Cancer Clinical Trial

Official title:
A Pilot Study, Single-Center, Open-Label, 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

Clinical Trial 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.

Clinical Trial Description

This is a pilot, single-center, open-label, 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04142931
Study type Interventional
Source Sheba Medical Center
Contact Ronnie Shapira, MD
Phone 972-3-5308414
Email ronnie.Shapira@sheba.health.gov.il
Status Recruiting
Phase Phase 1
Start date February 24, 2020
Completion date December 30, 2022
View Details
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