Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIsala
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Nivolumab
DrugGradual shortening of infusion times
Pembrolizumab
DrugGradual shortening of infusion times
Ipilimumab
DrugGradual shortening of infusion times
Durvalumab
DrugGradual shortening of infusion times
Atezolizumab
DrugGradual shortening of infusion times
Bevacizumab
DrugGradual shortening of infusion times
Trastuzumab
DrugGradual shortening of infusion times
Rituximab
DrugGradual shortening of infusion times
Treatment groups
776 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: NivolumabExperimental treatment 1 intervention
Group B: PembrolizumabExperimental treatment 1 intervention
Group C: ipilimumabExperimental treatment 1 intervention
Group D: DurvalumabExperimental treatment 1 intervention
Group E: AtezolizumabExperimental treatment 1 intervention
Group F: bevacizumabExperimental treatment 1 intervention
Group G: TrastuzumabExperimental treatment 1 intervention
Group H: RituximabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of infusion related reactions
Time frame
During or within 30 minutes after the end of the infusionSecondary outcomes
1
Plasma levels of the administered mAb
Time frame
Within 15 minutes before start of the infusionOther outcomes
1
Satisfaction with shortened infusion time assessed by the VAS
Scale 1-10, 1: not satisfied at all, 10: most satisfied
Time frame
Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody) Source ClinicalTrials.gov