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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06031233
Other study ID # NL83071.075.22 / 20221102
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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