Phase 4: testing Nivolumab for Oncology
This study is an treatment, 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.
Official registry: https://clinicaltrials.gov/study/NCT06031233 · Isala · enrollment listed as 1,082
What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Nivolumab, Pembrolizumab, or Ipilimumab. The registry lists allocation as randomized. This study is an treatment, 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.
They plan to enroll about 1,082 people at Zwolle. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study
Interventions: Nivolumab, Pembrolizumab, Ipilimumab, Durvalumab, Atezolizumab, Bevacizumab, Trastuzumab, Rituximab, Infliximab, Vedolizumab, Tociliuzumab
Primary outcome (registry wording): Incidence of infusion related reactions
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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)
Public study contact (from the registry)
Elianne CS de Boer
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Isala Hospital — Zwolle, Netherlands (recruiting)
FAQ about this NCT record
Is NCT06031233 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06031233?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06031233?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary