Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Oncology Clinical Trial

— MINUTE  

Official title:

Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031233
• Other study ID #: NL83071.075.22 / 20221102
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Isala
• Contact: Elianne CS de Boer
• Phone: +31886245000
• Email: polioncologie[@]isala.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 679
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Infusion Reaction
• Neoplasms
• Oncology

Intervention

Drug:
• Nivolumab
Gradual shortening of infusion times
• Pembrolizumab
Gradual shortening of infusion times
• Ipilimumab
Gradual shortening of infusion times
• Durvalumab
Gradual shortening of infusion times
• Atezolizumab
Gradual shortening of infusion times
• Bevacizumab
Gradual shortening of infusion times
• Trastuzumab
Gradual shortening of infusion times

Locations

Country	Name	City	State
Netherlands	Isala Hospital	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with shortened infusion time assessed by the VAS	Scale 1-10, 1: not satisfied at all, 10: most satisfied	Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody)
Primary	Incidence of infusion related reactions		During or within 30 minutes after the end of the infusion
Secondary	Plasma levels of the administered mAb		Within 15 minutes before start of the infusion