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Study on Nivolumab, Ipilimumab, and Bevacizumab for Patients with Non-Small Cell Lung Cancer Spread to the Brain

Verified siteRegistered drugNo placebo
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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 a type of lung cancer known as non-squamous non-small-cell lung cancer (NSCLC) that has spread to the brain. The study is testing a combination of treatments to see how safe and effective they are for patients with this condition. The treatments being used in this study include nivolumab, ipilimumab, and bevacizumab, along with two cycles of chemotherapy. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and potential benefits of this new combination of treatments. Participants will receive the treatments over a period of time, and researchers will monitor them for any side effects or improvements in their condition. The study aims to understand how these treatments can help manage the cancer that has spread to the brain and improve the quality of life for patients.

Throughout the study, the medical team will keep track of any changes in the participants' health, focusing on both the safety of the treatments and their effectiveness in controlling the cancer. The study will also look at how the treatments affect the central nervous system, which includes the brain and spinal cord. By the end of the study, researchers hope to gather valuable information that could lead to better treatment options for patients with this type of lung cancer.

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

    Initiation of treatment

    Upon joining the study, the treatment begins with the administration of carboplatin and paclitaxel. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

    This initial phase involves two cycles of chemotherapy. Each cycle typically lasts for a few weeks, with specific intervals between doses as determined by the study protocol.

  2. Step 2

    Combination therapy

    Following the chemotherapy cycles, the treatment continues with a combination of nivolumab, ipilimumab, and bevacizumab. These are also administered via intravenous infusion.

    The purpose of this combination is to target the cancer cells more effectively by using different mechanisms of action. The exact schedule and dosage are specified in the study protocol.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking for any side effects and measuring the response of the cancer, particularly in the brain.

    The study aims to evaluate the clinical benefit rate, which includes complete response, partial response, or stable disease for at least six months.

  4. Step 4

    Follow-up

    After completing the treatment regimen, follow-up visits are scheduled to continue monitoring the patient's health and any long-term effects of the treatment.

    These visits help in understanding the overall survival rate and progression-free survival, both in the brain and other parts of the body.

Who can join the trial?

20 criteria

  • You must have signed a written consent form approved by the appropriate authorities before any study-related procedures that are not part of your normal care.
  • You should not have had any previous chemotherapy or systemic therapy for cancer that has spread, except for certain types of therapy given before or after surgery.
  • Your last dose of any previous cancer treatment must have been given at least 21 days before starting the study treatment.
  • If you participated in another clinical trial or took an investigational drug, it must have ended at least 28 days before starting the study treatment.
  • You need to have adequate blood and organ function, which will be checked through specific blood tests within 14 days before starting the study treatment.
  • Your kidney function should be within a certain range, which will be checked through a blood test.
  • Your liver function should be within a certain range, with some exceptions for specific conditions, which will be checked through blood tests.
  • If you are a woman who can have children, you must have a negative pregnancy test within 3 days before starting the study drug.
  • Women must not be breastfeeding and should not start breastfeeding for at least six months after the last dose of a specific study drug.
  • Women must agree to use contraception during the study and for a certain period after completing the treatment.
  • Men should consider preserving sperm before treatment, as some study drugs may cause permanent infertility.
  • You must be willing and able to follow the study protocol.
  • Men who are sexually active with women who can have children must agree to use contraception during the study and for a certain period after completing the treatment.
  • You must be 18 years of age or older.
  • Your overall health status should be within a certain range, even if affected by brain-related symptoms.
  • You should have a life expectancy of at least 12 weeks.
  • Your cancer must be confirmed as a specific type of lung cancer that has spread to other parts of the body.
  • You must have measurable disease, which means the cancer can be measured using specific criteria.
  • You must have at least one measurable brain tumor that has not been treated with radiation and does not need immediate treatment.
  • Your tumor's PD-L1 status must be known, which is a specific characteristic of the tumor.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied, which is a specific type of lung cancer that has spread to the brain.
  • Patients who are not within the age range specified for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who have medical conditions or are taking medications that could interfere with the study treatment.
  • Patients who have had a recent major surgery or a serious illness that could affect their participation in the study.
  • Patients who are pregnant or breastfeeding, as the study treatment might not be safe for the baby.
  • Patients who have a history of allergic reactions to the study treatment or similar treatments.
  • Patients who are currently participating in another clinical trial or have recently participated in one.
  • Patients who have a history of substance abuse or other conditions that might affect their ability to follow the study procedures.
  • Patients who do not agree to follow the study requirements, such as attending all study visits and taking the study medication as directed.
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Investigated drugs

Nivolumab is a medication used in this trial to help the immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells. Ipilimumab is another medication in the trial that also helps the immune system fight cancer. It works by activating certain immune cells, which can then attack and kill cancer cells more effectively. Bevacizumab is included in the trial to help prevent the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, it can help slow down or stop the growth of cancer. The trial also involves two cycles of induction chemotherapy, which is a treatment that uses powerful drugs to kill cancer cells. This chemotherapy is given at the beginning of the treatment to reduce the size of the cancer and make the other treatments more effective.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered intravenously and is currently used in clinical trials for treating non-squamous non-small-cell lung cancer (NSCLC) that has spread to the brain. It is an immune checkpoint inhibitor that works by blocking the PD-1 protein on T cells, enhancing the immune system's ability to attack cancer cells. Nivolumab is classified as a monoclonal antibody and is being studied for its safety and effectiveness in combination with other treatments.

  • Ipilimumab

    Ipilimumab is given through an intravenous infusion and is being tested in clinical trials for its potential to treat brain metastases from non-squamous non-small-cell lung cancer (NSCLC). It functions by targeting the CTLA-4 protein on T cells, which helps to boost the immune response against cancer cells. Ipilimumab is a monoclonal antibody and is part of a combination therapy being evaluated for its safety and therapeutic benefits.

  • Bevacizumab

    Bevacizumab is administered via intravenous infusion and is under investigation in clinical trials for its role in treating non-squamous non-small-cell lung cancer (NSCLC) with brain metastases. It works by inhibiting vascular endothelial growth factor (VEGF), which reduces the blood supply to tumors, potentially slowing their growth. Bevacizumab is classified as an angiogenesis inhibitor and is being studied in combination with other drugs to assess its safety and efficacy.

Investigated diseases

Non-squamous non-small-cell lung cancer (NSCLC) metastatic to the brain – This type of lung cancer originates in the lung tissues and is characterized by the absence of squamous cells. It is a subtype of non-small-cell lung cancer, which is the most common type of lung cancer. When it metastasizes to the brain, it means that cancer cells have spread from the lungs to the brain. This progression can lead to neurological symptoms due to the impact on brain function. The disease can cause headaches, seizures, or changes in behavior and cognitive abilities. The spread to the brain often indicates an advanced stage of cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512684-31-00Protocol codeCA209-7WF/ Break B5Estimated enrolment39 patientsSponsorUniversitaetsklinikum Regensburg AöR

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