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Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Recruiting
18 years of age
Both
Phase 4

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Overview

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.

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.

Eligibility

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).

Study details

Oncology, Infusion Reaction

NCT06031233

Isala

21 March 2024

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