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Study on the Safety of Faster Infusions for Cancer Patients Using Trastuzumab, Bevacizumab, and Atezolizumab

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety of shortened infusion times for various cancer treatments known as monoclonal antibodies. These treatments include nivolumab, pembrolizumab, ipilimumab, bevacizumab, trastuzumab, durvalumab, atezolizumab, and rituximab. Monoclonal antibodies are a type of protein made in the lab that can bind to substances in the body, including cancer cells. The purpose of the study is to determine how often and how severe infusion-related reactions occur when these medications are given more quickly than usual.

Participants in the study will receive one of the mentioned treatments through an intravenous infusion, which means the medication is delivered directly into a vein. The study will observe and record any reactions that occur during these faster infusions. These reactions can include symptoms like fever, chills, or rash, which are sometimes experienced when the body responds to the medication. The study will compare these reactions to those recorded in past treatments where the infusions were given at a standard pace.

The study will continue over a period of time, with participants receiving their treatments and being monitored for any side effects. The goal is to gather information on whether these faster infusions are safe and to understand the experiences of patients undergoing these treatments. This information could help improve the way these cancer therapies are administered in the future, potentially making them more convenient for patients. The study will also look at other factors such as the effectiveness of the treatment and the overall experience of the patients involved.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years and older), current or planned treatment with specific monoclonal antibodies, and no known history of increased susceptibility to immunological reactions.

    The patient signs an informed consent form before any screening evaluations.

  2. Step 2

    Treatment administration

    The study involves the administration of monoclonal antibodies through intravenous infusion. The medications include trastuzumab, bevacizumab, atezolizumab, rituximab, nivolumab, pembrolizumab, ipilimumab, and durvalumab.

    Each medication is provided in a specific form and dosage, such as Herceptin 150 mg, Avastin 25 mg/ml, Tecentriq 1 875 mg, Truxima 500 mg, OPDIVO 10 mg/mL, KEYTRUDA 25 mg/mL, YERVOY 5 mg/ml, and IMFINZI 50 mg/mL.

  3. Step 3

    Monitoring and evaluation

    The main objective is to determine the incidence and severity of infusion-related reactions using established criteria.

    Secondary evaluations include treatment efficacy, plasma levels of the drug, patient-reported experiences, and the number of treatments required.

  4. Step 4

    Completion of the study

    The study is expected to conclude by July 1, 2026.

    Throughout the study, data on infusion reactions, treatment efficacy, and patient experiences are collected and analyzed.

Who can join the trial?

4 criteria

  • Currently starting or already receiving treatment with specific **monoclonal antibodies**. These are special proteins used in cancer treatment. The specific ones include nivolumab, pembrolizumab, ipilimumab, bevacizumab, trastuzumab, durvalumab, atezolizumab, or rituximab.
  • Must be **18 years or older**.
  • No known history of increased susceptibility to **immunological reactions**, which means the person should not have a history of unusual or severe reactions to immune system-related treatments.
  • Must be able and willing to sign the **Informed Consent Form** before any screening evaluations. This means the person agrees to participate in the study after understanding all the details.

Who cannot join the trial?

9 criteria

  • Patients with certain types of cancer may not be eligible.
  • Individuals who have had severe allergic reactions to similar treatments in the past might be excluded.
  • Participants who are not within the specified age range for the study may not qualify.
  • People with certain medical conditions that could interfere with the study results might be excluded.
  • Individuals who are unable to follow the study procedures or attend required visits may not be eligible.
  • Patients who are part of another clinical trial at the same time might be excluded.
  • Pregnant or breastfeeding women may not be eligible to participate.
  • Individuals with a history of substance abuse that could affect the study results might be excluded.
  • Patients with certain infections or diseases that could interfere with the study may not qualify.
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Investigated drugs

Oncological Immunotherapies: These are treatments that use the body's immune system to fight cancer. In this study, the focus is on evaluating the safety of administering these therapies over a shorter period of time. The goal is to see if this faster infusion causes any reactions or side effects in patients.

What is already known about the treatment

Oncological Immunotherapy – This medication is administered through infusion, typically in a hospital or clinical setting. It is currently being studied in clinical trials to evaluate the safety of shortened infusion times. The main therapeutic use is in oncology, specifically for treating various types of cancer. At the molecular level, it works by enhancing the immune system's ability to recognize and attack cancer cells. It is classified as a monoclonal antibody, a type of targeted therapy that specifically binds to cancer cell antigens.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. If the spread is not controlled, it can interfere with essential bodily functions. Cancer can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. The progression of cancer typically involves stages, starting from a localized tumor to potential metastasis, where cancer cells spread to other parts of the body. The rate of progression can vary significantly depending on the type of cancer and individual factors. Symptoms may include lumps, abnormal bleeding, prolonged cough, unexplained weight loss, and changes in bowel movements.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518878-14-01Estimated enrolment1 261 patientsSponsorIsala Klinieken Stichting

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).