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

Isala

Status and phase: Enrolling; Phase 4

Conditions: Oncology; Infusion Reaction

Treatments: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Ipilimumab; Drug: Nivolumab; Drug: Trastuzumab; Drug: Durvalumab; Drug: Pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06031233

NL83071.075.22 / 20221102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 679 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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679 participants in 7 patient groups

Nivolumab

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Pembrolizumab

Experimental group

Description:

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

Treatment:

Drug: Pembrolizumab

ipilimumab

Experimental group

Description:

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

Treatment:

Drug: Ipilimumab

Durvalumab

Experimental group

Description:

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

Treatment:

Drug: Durvalumab

Atezolizumab

Experimental group

Description:

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

Treatment:

Drug: Atezolizumab

bevacizumab

Experimental group

Description:

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

Treatment:

Drug: Bevacizumab

Trastuzumab

Experimental group

Description:

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

Treatment:

Drug: Trastuzumab