RecruitingPhase 4NCT06031233

Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study


Sponsor

Isala

Enrollment

776 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab.
  • 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 Criteria4

  • 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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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


Locations(1)

Isala Hospital

Zwolle, Netherlands

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NCT06031233


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