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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oncology; Infusion Reaction
• Intervention / Treatment: Drug: Nivolumab; Drug: Pembrolizumab; Drug: Ipilimumab; Drug: Durvalumab; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Trastuzumab; Drug: Rituximab

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 Type: Interventional
• Enrollment (Estimated): 776
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Elianne CS de Boer; Phone Number: +31886245000; Email: polioncologie@isala.nl

Study Locations

• Netherlands
  • Zwolle, Netherlands, 8025AB
    • Recruiting
    • Isala Hospital
    • Contact: Elianne CS de Boer; Phone Number: +31886245000; Email: polioncologie@isala.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / 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
Experimental: Rituximab; If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 15 minutes in the following cycles.	Drug: Rituximab; Gradual shortening of infusion times

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Isala

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Trastuzumab; Nivolumab; Bevacizumab; Rituximab; Ipilimumab; pembrolizumab; durvalumab; atezolizumab
• Other Study ID Numbers: NL83071.075.22 / 20221102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No