Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Phase 4

Recruiting

• Conditions: Oncology; Infusion Reaction
• Interventions: Drug: Nivolumab; Drug: Ipilimumab; Drug: Durvalumab; Drug: Pembrolizumab; Drug: Trastuzumab; Drug: Atezolizumab; Drug: Bevacizumab

• Registration Number: NCT06031233
• Lead Sponsor: Isala

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.

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 Timeline

• Study First Submitted: 2023-04-24
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-11
• Status Verified: 2024-10
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 679

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab	Nivolumab	If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
ipilimumab	Ipilimumab	If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Durvalumab	Durvalumab	If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Pembrolizumab	Pembrolizumab	If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Trastuzumab	Trastuzumab	If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
Atezolizumab	Atezolizumab	If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
bevacizumab	Bevacizumab	If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.

Primary Outcome Measures

Name	Time	Method
Incidence of infusion related reactions	During or within 30 minutes after the end of the infusion

Secondary Outcome Measures

Name	Time	Method
Plasma levels of the administered mAb	Within 15 minutes before start of the infusion

Trial Locations

Locations (1)

Isala Hospital; 🇳🇱 Zwolle, Netherlands