Trials / Unknown
UnknownNCT04142931
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
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Dr. Ronnie Shapira · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Stage IV Non-small Cell Lung Cancer
- Stage IV Melanoma
- Triple Negative Breast Cancer
- Renal Cell Carcinoma Stage IV
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | ImmunicomAIAC | filtration through the ImmunicomAIAC followed by Nivolumab Administrated IV starting C2. |
Timeline
- Start date
- 2020-02-24
- Primary completion
- 2021-12-30
- Completion
- 2022-12-30
- First posted
- 2019-10-29
- Last updated
- 2021-03-24
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04142931. Inclusion in this directory is not an endorsement.