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NCT Number: NCT06031233

Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

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.

Recruiting

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Key information

Conditions

Oncology Infusion Reaction Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nivolumab

Drug

Gradual shortening of infusion times

Pembrolizumab

Drug

Gradual shortening of infusion times

Ipilimumab

Drug

Gradual shortening of infusion times

Durvalumab

Drug

Gradual shortening of infusion times

Atezolizumab

Drug

Gradual shortening of infusion times

Bevacizumab

Drug

Gradual shortening of infusion times

Trastuzumab

Drug

Gradual shortening of infusion times

Rituximab

Drug

Gradual shortening of infusion times

Primary outcomes

  1. Incidence of infusion related reactions

    Time frame: During or within 30 minutes after the end of the infusion

Secondary outcomes

  1. Plasma levels of the administered mAb

    Time frame: Within 15 minutes before start of the infusion

Other outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Elianne CS de Boer

CONTACT

[email protected]

+31886245000

Sponsors and collaborators

Lead sponsor

Isala

Other

Registry information

Official study title

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

Acronym: MINUTE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 11, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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