All malignancies that are treated with intravenous monoclonal antibodies
Conditions
Interventions
None
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| To set up a bank of prospectively collected blood samples from patients treated with monoclonal antibodies. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Contacts
Public ContactEdwin Basak
Outcome results
None listed