OncologyPhase 4MINUTENCT06031233
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
A Phase 4 study testing Nivolumab, Pembrolizumab and Ipilimumab in people with Oncology and Infusion Reaction, run by Isala at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Infusion Reaction
- What is being tested?
- Nivolumab, Pembrolizumab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,082 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2023to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Isala Hospital
Zwolle, 8025AB
Elianne CS de Boer, +31886245000, polioncologie@isala.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Oncology, Infusion Reaction
- Being tested
- Nivolumab, Pembrolizumab, Ipilimumab, Durvalumab, Atezolizumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Gradual shortening of infusion times
PembrolizumabDrug
Gradual shortening of infusion times
IpilimumabDrug
Gradual shortening of infusion times
DurvalumabDrug
Gradual shortening of infusion times
AtezolizumabDrug
Gradual shortening of infusion times
BevacizumabDrug
Gradual shortening of infusion times
TrastuzumabDrug
Gradual shortening of infusion times
RituximabDrug
Gradual shortening of infusion times
InfliximabDrug
Gradual shortening of infusion times
VedolizumabDrug
Gradual shortening of infusion times
TociliuzumabDrug
Gradual shortening of infusion times
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. Receives: Drug: Nivolumab |
| Pembrolizumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. Receives: Drug: Pembrolizumab |
| ipilimumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. Receives: Drug: Ipilimumab |
| Durvalumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. Receives: Drug: Durvalumab |
| Atezolizumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. Receives: Drug: Atezolizumab |
| bevacizumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. Receives: Drug: Bevacizumab |
| Trastuzumab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. Receives: Drug: Trastuzumab |
| Rituximab | Experimental | If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 15 minutes in the following cycles. Receives: Drug: Rituximab |
| Infliximab | Experimental | If no infusion reaction has occurred after 6 cycles, infusion time will stepwise be shortened to 10 minutes in the following cycles. Receives: Drug: Infliximab |
| Vedolizumab | Experimental | If no infusion reaction has occurred after 2 cycles, infusion time will stepwise be shortened to 1 minutes in the following cycles. Receives: Drug: Vedolizumab |
| Tocilizumab | Experimental | If no infusion reaction has occurred after 2 cycles, infusion time will stepwise be shortened to 10 minutes in the following cycles. Receives: Drug: Tociliuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infusion related reactions
Measured: During or within 30 minutes after the end of the infusion
Secondary outcomes (1)
Plasma levels of the administered mAb
Measured: Within 15 minutes before start of the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Sep 2023
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,082 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HB Fiebrich-Westra, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031233
- Sponsor's protocol ID
- NL83071.075.22 / 20221102
- Acronym
- MINUTE
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT06031233
- Acronym / sponsor ID
- MINUTE / NL83071.075.22 / 20221102
- Conditions
- Oncology, Infusion Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,082 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: NivolumabIf no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
| Pembrolizumab | Experimental | Drug: PembrolizumabIf no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
| ipilimumab | Experimental | Drug: IpilimumabIf no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
| Durvalumab | Experimental | Drug: DurvalumabIf no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
| Atezolizumab | Experimental | Drug: AtezolizumabIf no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
| bevacizumab | Experimental | Drug: BevacizumabIf no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
| Trastuzumab | Experimental | Drug: TrastuzumabIf no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
| Rituximab | Experimental | Drug: RituximabIf no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 15 minutes in the following cycles. |
| Infliximab | Experimental | Drug: InfliximabIf no infusion reaction has occurred after 6 cycles, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
| Vedolizumab | Experimental | Drug: VedolizumabIf no infusion reaction has occurred after 2 cycles, infusion time will stepwise be shortened to 1 minutes in the following cycles. |
| Tocilizumab | Experimental | Drug: TociliuzumabIf no infusion reaction has occurred after 2 cycles, infusion time will stepwise be shortened to 10 minutes in the following cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabGradual shortening of infusion times | Drug | Nivolumab |
| PembrolizumabGradual shortening of infusion times | Drug | Pembrolizumab |
| IpilimumabGradual shortening of infusion times | Drug | ipilimumab |
| DurvalumabGradual shortening of infusion times | Drug | Durvalumab |
| AtezolizumabGradual shortening of infusion times | Drug | Atezolizumab |
| BevacizumabGradual shortening of infusion times | Drug | bevacizumab |
| TrastuzumabGradual shortening of infusion times | Drug | Trastuzumab |
| RituximabGradual shortening of infusion times | Drug | Rituximab |
| InfliximabGradual shortening of infusion times | Drug | Infliximab |
| VedolizumabGradual shortening of infusion times | Drug | Vedolizumab |
| TociliuzumabGradual shortening of infusion times | Drug | Tocilizumab |
Primary outcome
Incidence of infusion related reactions
Time frame: During or within 30 minutes after the end of the infusion
1 secondary outcome
Plasma levels of the administered mAb
Time frame: Within 15 minutes before start of the infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nivolumab, Pembrolizumab and Ipilimumab in people with Oncology and Infusion Reaction, run by Isala at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elianne CS de Boer (+31886245000, polioncologie@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infusion related reactions (time frame: During or within 30 minutes after the end of the infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.