Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Sponsor
Isala
Study ID
NCT06031233
Phase
PHASE4
Status
Recruiting
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Conditions

  • Infusion Reaction
  • Oncology

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
776 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  • Experimental: Pembrolizumab
    If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  • Experimental: ipilimumab
    If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  • Experimental: Durvalumab
    If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  • Experimental: Atezolizumab
    If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  • Experimental: bevacizumab
    If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  • Experimental: Trastuzumab
    If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  • Experimental: Rituximab
    If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 15 minutes in the following cycles.

Primary Outcome Measure

Incidence of infusion related reactions [ Time Frame: During or within 30 minutes after the end of the infusion ]

Central Contacts

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