Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
Recruiting
Phase 4Interventional Study
OncologyInfusion Reaction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
776 (estimated)
Sponsor
Isala · Other
Who this trial is looking for
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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.
Trial Locations
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City
State
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Status
Eligibility Criteria
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 …
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).
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