Infusion Reaction, Oncology
Conditions
Brief summary
This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile. Infusion times will be gradually shortened if tolerability allowes.
Detailed description
After two cycles with normal infusion times, infusion time will be shortened to 15 mintues en 10 minutes subsequently if no infusion reaction occurs. Patient satisfaction will be evaluated.
Interventions
DRUGNivolumab
Gradual shortening of infusion times
DRUGPembrolizumab
Gradual shortening of infusion times
DRUGIpilimumab
Gradual shortening of infusion times
DRUGDurvalumab
Gradual shortening of infusion times
DRUGAtezolizumab
Gradual shortening of infusion times
DRUGBevacizumab
Gradual shortening of infusion times
DRUGTrastuzumab
Gradual shortening of infusion times
DRUGRituximab
Gradual shortening of infusion times
Sponsors
Isala
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab. * 18 years and older. * No known history of increased susceptibility to immunological reactions. * Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
Exclusion criteria
* Other research medication within 4 weeks of the start of the study. * Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions * Dosage deviates from standard protocol * Patients whom receive drugs through a central venous catheter (and for example porth-a-cath).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of infusion related reactions | During or within 30 minutes after the end of the infusion |
Secondary
| Measure | Time frame |
|---|---|
| Plasma levels of the administered mAb | Within 15 minutes before start of the infusion |
Countries
Netherlands
Contacts
CONTACTElianne CS de Boer
Outcome results
None listed