Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Oncology, Infusion Reaction

Intervention / Treatment
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* Drug: Nivolumab
* Drug: Pembrolizumab
* Drug: Ipilimumab
* Drug: Durvalumab
* Drug: Atezolizumab
* Drug: Bevacizumab
* Drug: Trastuzumab


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infusion related reactions |  | During or within 30 minutes after the end of the infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of the administered mAb |  | Within 15 minutes before start of the infusion |