MedTrace Logo

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 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-03-24

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

ImmunicomAIAC

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

Sponsors & Collaborators

  • Immunicom Inc. San Diego California, USA

    collaborator UNKNOWN

  • Dr. Ronnie Shapira

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04142931 on ClinicalTrials.gov