Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Isala
- Enrollment
- 679
- Locations
- 1
- Primary Endpoint
- Incidence of infusion related reactions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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).
Arms & Interventions
Nivolumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Intervention: Nivolumab (Drug)
Pembrolizumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Intervention: Pembrolizumab (Drug)
ipilimumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Intervention: Ipilimumab (Drug)
Durvalumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Intervention: Durvalumab (Drug)
Atezolizumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Intervention: Atezolizumab (Drug)
bevacizumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Intervention: Bevacizumab (Drug)
Trastuzumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Intervention: Trastuzumab (Drug)
Outcomes
Primary Outcomes
Incidence of infusion related reactions
Time Frame: During or within 30 minutes after the end of the infusion
Secondary Outcomes
- Plasma levels of the administered mAb(Within 15 minutes before start of the infusion)
Investigators
HB Fiebrich-Westra
Principal Investigator
Isala