NCT06031233

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
776

participants targeted

Target at P75+ for phase_4

Timeline
31mo left

Started Sep 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Sep 2023Dec 2028

First Submitted

Initial submission to the registry

April 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

April 24, 2023

Last Update Submit

March 25, 2026

Conditions

OncologyInfusion Reaction

Outcome Measures

Primary Outcomes (1)

  • Incidence of infusion related reactions

    During or within 30 minutes after the end of the infusion

Secondary Outcomes (1)

  • Plasma levels of the administered mAb

    Within 15 minutes before start of the infusion

Other Outcomes (1)

  • Satisfaction with shortened infusion time assessed by the VAS

    Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody)

Study Arms (8)

Nivolumab

EXPERIMENTAL

If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.

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.

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.

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.

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.

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.

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.

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.

Drug: Rituximab

Interventions

NivolumabDRUG

Gradual shortening of infusion times

Nivolumab
PembrolizumabDRUG

Gradual shortening of infusion times

Pembrolizumab
IpilimumabDRUG

Gradual shortening of infusion times

ipilimumab
DurvalumabDRUG

Gradual shortening of infusion times

Durvalumab
AtezolizumabDRUG

Gradual shortening of infusion times

Atezolizumab
BevacizumabDRUG

Gradual shortening of infusion times

bevacizumab
TrastuzumabDRUG

Gradual shortening of infusion times

Trastuzumab
RituximabDRUG

Gradual shortening of infusion times

Rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab.
  • 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.

You may not qualify if:

  • Other research medication within 4 weeks of the start of the study.
  • Dosage deviates from standard protocol
  • Patients whom receive drugs through a central venous catheter (and for example porth-a-cath).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Hospital

Zwolle, 8025AB, Netherlands

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

NivolumabpembrolizumabIpilimumabdurvalumabatezolizumabBevacizumabTrastuzumabRituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Murine-Derived

Central Study Contacts

Elianne CS de Boer

CONTACT

+31886245000polioncologie@isala.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2023

First Posted

September 11, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)