No registrations found.
ID
Source
Brief title
Health condition
All malignancies that are treated with intravenous monoclonal antibodies
Sponsors and support
Intervention
Outcome measures
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.
Background summary
To set up a bank of prospectively collected blood samples for pharmacokinetic analyses of monoclonal antibodies and immunophenotyping
Study objective
To set up a bank of prospectively collected blood samples for pharmacokinetic analyses of monoclonal antibodies and immunophenotyping
Study design
Prior to every infusion.
Intervention
None
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6828 |
| NTR-old | NTR7015 |
| Other | : MEC 16-011 |