A Phase 4 interventional study of Nivolumab and Pembrolizumab in Oncology and Infusion Reaction, sponsored by Isala. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Isala · Phase 4, Interventional, and Treatment
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.
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.
9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.
This study's planned enrollment of 776 is above the median of 50 across 7,258 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Isala is the lead sponsor of 36 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Drug: Nivolumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Drug: Pembrolizumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Drug: Ipilimumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Drug: Durvalumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Drug: Atezolizumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Drug: Bevacizumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Drug: Trastuzumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 15 minutes in the following cycles.
Drug: Rituximab
Gradual shortening of infusion times
Gradual shortening of infusion times
Gradual shortening of infusion times
Gradual shortening of infusion times
Gradual shortening of infusion times
Gradual shortening of infusion times
Gradual shortening of infusion times
Gradual shortening of infusion times
Incidence of infusion related reactions
Time frame: During or within 30 minutes after the end of the infusion
Plasma levels of the administered mAb
Time frame: Within 15 minutes before start of the infusion
Satisfaction with shortened infusion time assessed by the VAS
Scale 1-10, 1: not satisfied at all, 10: most satisfied
Time frame: Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody)
Plan to share: No
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