|- candidate number||28533|
|- NTR Number||NTR7015|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-feb-2018|
|- Secondary IDs||MEC 16-011 |
|- Public Title||Blood sampling of oncology patients treated with monoclonal antibodies|
|- Scientific Title||Prospective sampling in intravenously treated oncology patients: monoclonal antibodies|
|- hypothesis||To set up a bank of prospectively collected blood samples for pharmacokinetic analyses of monoclonal antibodies and immunophenotyping|
|- Healt Condition(s) or Problem(s) studied||Monoclonal antibodies, Blood withdrawal, Cancer patients|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria:|
• Age ≥18 years
• Able to understand the written information and able to give informed consent
• Planned treatment with (intravenous) monoclonal antibodies for any type of cancer according to standard of care. Monoclonal antibodies include, but are not limited to: cetuximab, nivolumab, ipilimumab, pembrolizumab, bevacizumab, and trastuzumab.
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation in this study:|
• Unable to draw blood for study purposes
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||5-apr-2016|
|- planned closingdate||1-jan-2026|
|- Target number of participants||1000|
|- Primary outcome||To set up a bank of prospectively collected blood samples from patients treated with monoclonal antibodies.|
|- Secondary outcome||- To correlate pharmacokinetic (PK) parameters with effectiveness and toxicity of monoclonal antibodies.|
- To determine the influence of immunogenicity on PK.
- To determine the influence of peripheral blood immune cell characteristics on PK and effectiveness and toxicity of monoclonal antibodies.
- Explore the characteristics of exosomes before start of treatment, during treatment, and after disease progression.
- To assess the course of PK and PBMC characteristics shortly after the first treatment cycle, i.e. within 1 week.- To validate an assay that can determine serum concentrations of monoclonal antibodies.
|- Timepoints||Prior to every infusion.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Edwin Basak|
|- CONTACT for SCIENTIFIC QUERIES|| Edwin Basak|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||To set up a bank of prospectively collected blood samples for pharmacokinetic analyses of monoclonal antibodies and immunophenotyping|
|- Main changes (audit trail)|
|- RECORD||6-feb-2018 - 22-feb-2018|