Status:
RECRUITING
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
Lead Sponsor:
Isala
Conditions:
Oncology
Infusion Reaction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalum...
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
679 Patients enrolled
Trial Details
Trial ID
NCT06031233
Start Date
September 1 2023
End Date
December 1 2026
Last Update
May 21 2025
Active Locations (1)
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1
Isala Hospital
Zwolle, Netherlands, 8025AB