Shortening infusion times for cancer immunotherapy
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study
This study is testing if shortening the time it takes to receive certain cancer immunotherapy treatments is safe and if it makes patients happier with their experience.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 776 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Isala Academic / other |
| Drugs / interventions | nivolumab, pembrolizumab, ipilimumab, bevacizumab, trastuzumab, durvalumab, atezolizumab |
| Locations | 1 site (Zwolle) |
| Trial ID | NCT06031233 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the safety of reducing infusion times for patients receiving various monoclonal antibodies, including nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab, and atezolizumab. After two cycles with standard infusion durations, the study will gradually shorten the infusion times to 15 and then 10 minutes, provided that no infusion reactions occur. Patient satisfaction will also be assessed throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are starting treatment with the specified monoclonal antibodies and have no history of increased susceptibility to immunological reactions.
Not a fit: Patients who have received other research medications within four weeks prior to the study or those requiring infusions through a central venous catheter may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient comfort and convenience by reducing the time spent receiving treatment.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a relatively novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Zwolle
- Isala Hospital — Zwolle, Netherlands (Recruiting)
Study contacts
- Study coordinator: Elianne CS de Boer
- Email: polioncologie@isala.nl
- Phone: +31886245000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.