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Recruiting NCT06031233

Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Phase IV Interventional Oncology Infusion Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nivolumab, Pembrolizumab, Ipilimumab, Durvalumab.
Who it may be relevant to
Registry conditions: Oncology, Infusion Reaction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

  • Drug Nivolumab
    Gradual shortening of infusion times
  • Drug Pembrolizumab
    Gradual shortening of infusion times
  • Drug Ipilimumab
    Gradual shortening of infusion times
  • Drug Durvalumab
    Gradual shortening of infusion times
  • Drug Atezolizumab
    Gradual shortening of infusion times
  • Drug Bevacizumab
    Gradual shortening of infusion times
  • Drug Trastuzumab
    Gradual shortening of infusion times
  • Drug Rituximab
    Gradual shortening of infusion times

Primary outcome measures

  • Incidence of infusion related reactions [Time frame: During or within 30 minutes after the end of the infusion]
Secondary outcome measures (1)
  • Plasma levels of the administered mAb [Time frame: Within 15 minutes before start of the infusion]

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 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Isala Hospital — Zwolle

Identifiers

NCT: NCT06031233 · NL83071.075.22 / 20221102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗