MINUTE: Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Sponsor

Isala (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06031233

Collaborator

(none)

679

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is an observational, 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.

Condition or Disease	Intervention/Treatment	Phase
Oncology Infusion Reaction	Drug: Nivolumab Drug: Pembrolizumab Drug: Ipilimumab Drug: Durvalumab Drug: Atezolizumab Drug: Bevacizumab Drug: Trastuzumab	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

679 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nivolumab If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.	Drug: Nivolumab Gradual shortening of infusion times
Experimental: Pembrolizumab If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.	Drug: Pembrolizumab Gradual shortening of infusion times
Experimental: ipilimumab If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.	Drug: Ipilimumab Gradual shortening of infusion times
Experimental: Durvalumab If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.	Drug: Durvalumab Gradual shortening of infusion times
Experimental: Atezolizumab If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.	Drug: Atezolizumab Gradual shortening of infusion times
Experimental: bevacizumab If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.	Drug: Bevacizumab Gradual shortening of infusion times
Experimental: Trastuzumab If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.	Drug: Trastuzumab Gradual shortening of infusion times

Outcome Measures

Primary Outcome Measures

Incidence of infusion related reactions [During or within 30 minutes after the end of the infusion]

Secondary Outcome Measures

Plasma levels of the administered mAb [Within 15 minutes before start of the infusion]

Other Outcome Measures

Satisfaction with shortened infusion time assessed by the VAS [Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody)]
Scale 1-10, 1: not satisfied at all, 10: most satisfied

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).