Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie (NCT06031233) | Clinical Trial Compass
RecruitingPhase 4
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
Netherlands776 participantsStarted 2023-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of infusion related reactions
Timeframe: During or within 30 minutes after the end of the infusion