Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06031233
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2023-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
Sponsor:
Isala
Organization:
Study Overview
Official Title:
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINUTE
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.
Infusion times will be gradually shortened if tolerability allowes.
Detailed Description:
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.
Patient satisfaction will be evaluated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: