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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |