Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Necrosis

Melanoma

Carcinoma, Renal Cell

Neoplasms by Histologic Type

Skin Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Breast Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

filtration of 2X PV through the ImmunicomAIAC

filtration of 2X PV through the Immunicom AIAC, and nivolumab 240 mg given every 14 days for 4 times. Nivolumab will be initiated in C2.

filtration through the ImmunicomAIAC followed by Nivolumab Administrated IV starting C2.

ImmunicomAIAC

Ronnie Shapira, MD

Meital Bar

Ronnie Shapira, Dr.

Ronnie Shapira, Dr

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.

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.

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

number of patients with adverse events that emerged due to IA

number of patients with adverse events that emerged due to IA therapy in combination with nivolumab.

Changes in sTNFR-1/2 pre and post AIAC column between start and end of every treatment session, and between start and end of every cycle Total capture of sTNF-R1/2 on each column post treatment will be measured using an elution procedure

The biochemical efficacy will be evaluated throughout the study by measuring the changes of sTNFR-1/2 and TNFα in the plasma in several pre-defined time points - before, during and post every AIAC treatment

Response Rate (RR) as determined by RECIST v1.1

changes in plasma cytokines levels: sTNFR-I (pg/ml), sTNFR-II (pg/ml), TNF (pg/ml), pre and post treatment.

changes in peripheral blood mononuclear cells (PBMC) phenotypes pre and post treatment

Duration of response (DoR) as determined by RECIST v1.1

Clinical benefit rate (CBR) defined as CR plus PR plus stable disease (SD) ≥6 months

Progression-Free Survival (PFS) as determined by RECIST v1.1

Eastern Cooperative Oncology Group (ECOG) status (score 0-4)

Overall quality of life scale: 1 (very poor), 7 (excellent). higher score mean better outcome

patient's health state: 1- 'The best health you can imagine' , 5- 'The worst health you can imagine'. higher score mean worse outcome

measure anxiety and depression in a general medical population of patients. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Spots Global Cancer Trial Database for immunicomaiac