Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie (MINUTE)
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ClinicalTrials.gov Identifier: NCT06031233 |
Recruitment Status :
Recruiting
First Posted : September 11, 2023
Last Update Posted : March 7, 2024
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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 |
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 |
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.
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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.
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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 |
- Incidence of infusion related reactions [ Time Frame: During or within 30 minutes after the end of the infusion ]
- Plasma levels of the administered mAb [ Time Frame: Within 15 minutes before start of the infusion ]
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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
Contact: Elianne CS de Boer | +31886245000 | polioncologie@isala.nl |
Netherlands | |
Isala Hospital | Recruiting |
Zwolle, Netherlands, 8025AB | |
Contact: Elianne CS de Boer +31886245000 polioncologie@isala.nl |
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 |
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 |
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 |