Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Last updated: March 5, 2024
Sponsor: Isala
Overall Status: Active - Recruiting

Phase

4

Condition

Neoplasms

Cancer

Treatment

Bevacizumab

Trastuzumab

Ipilimumab

Clinical Study ID

NCT06031233
NL83071.075.22 / 20221102
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 screeningevaluations.

Exclusion

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 followits stated times and dosages of infusions
  • Dosage deviates from standard protocol
  • Patients whom receive drugs through a central venous catheter (and for exampleporth-a-cath).

Study Design

Total Participants: 679
Treatment Group(s): 7
Primary Treatment: Bevacizumab
Phase: 4
Study Start date:
September 01, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Isala Hospital

    Zwolle, 8025AB
    Netherlands

    Active - Recruiting

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