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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06031233
Recruitment Status : Recruiting
First Posted : September 11, 2023
Last Update Posted : March 7, 2024
Sponsor:
Information provided by (Responsible Party):
HB Fiebrich-Westra, Isala

Study Description
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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.


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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of infusion related reactions [ Time Frame: During or within 30 minutes after the end of the infusion ]

Secondary Outcome Measures :
  1. Plasma levels of the administered mAb [ Time Frame: Within 15 minutes before start of the infusion ]

Other Outcome Measures:
  1. Satisfaction with shortened infusion time assessed by the VAS [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031233


Contacts
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Contact: Elianne CS de Boer +31886245000 polioncologie@isala.nl

Locations
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Netherlands
Isala Hospital Recruiting
Zwolle, Netherlands, 8025AB
Contact: Elianne CS de Boer    +31886245000    polioncologie@isala.nl   
Sponsors and Collaborators
Isala
More Information
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Responsible Party: HB Fiebrich-Westra, Principal Investigator, Isala
ClinicalTrials.gov Identifier: NCT06031233    
Other Study ID Numbers: NL83071.075.22 / 20221102
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neoplasms
Bevacizumab
Pembrolizumab
Nivolumab
Trastuzumab
Ipilimumab
Atezolizumab
Durvalumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action