NCT06031233 Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
| NCT ID | NCT06031233 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Isala |
| Condition | Oncology |
| Study Type | INTERVENTIONAL |
| Enrollment | 776 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 776 participants in total. It began in 2023-09-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, durvalumab or atezolizumab continues to be associated with an acceptable safety profile. Infusion times will be gradually shortened if tolerability allowes.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06031233 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oncology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06031233 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06031233 currently recruiting?
Yes, NCT06031233 is actively recruiting participants. Contact the research team at polioncologie@isala.nl for enrollment information.
Where is the NCT06031233 trial being conducted?
This trial is being conducted at Zwolle, Netherlands.
Who is sponsoring the NCT06031233 clinical trial?
NCT06031233 is sponsored by Isala. The trial plans to enroll 776 participants.