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Study of Cabozantinib and Avelumab for Patients with Advanced Neuroendocrine Tumors G3 Resistant to Standard Chemotherapy

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 cancer known as advanced neuroendocrine neoplasias G3 (NEN G3). These are rare tumors that arise from hormone-producing cells and are often aggressive. The study is investigating a combination treatment using two medications: Cabozantinib and Avelumab. Cabozantinib, also known by its code name XL-184, is taken as a tablet, while Avelumab is given as an infusion directly into the bloodstream.

The purpose of the study is to explore how effective and safe this combination treatment is for patients whose cancer has not responded to standard chemotherapy. Participants in the study will receive either the combination of Cabozantinib and Avelumab or Avelumab alone. The study will last for up to 12 months, during which time the participants' health and response to the treatment will be closely monitored. Tumor assessments will be conducted every 8 weeks for the first 6 months and then every 12 weeks thereafter to track the progress of the disease.

This trial aims to provide new insights into the treatment of advanced neuroendocrine neoplasias G3, potentially offering new hope for patients with this challenging condition. The study will help determine if the combination of Cabozantinib and Avelumab can better control the disease compared to Avelumab alone. Participants will be monitored for any side effects and changes in their quality of life throughout the study period.

The research process

The trial runs in 7 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 specific criteria such as age, medical history, and previous treatments.

    Written informed consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current state of the disease using imaging techniques.

    A sample of tumor tissue is collected for further analysis.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of Cabozantinib and Avelumab.

    Cabozantinib is taken orally in the form of film-coated tablets, available in 20 mg and 40 mg doses.

    Avelumab is administered intravenously as a solution for infusion.

  4. Step 4

    Treatment schedule

    The treatment involves regular administration of the medications as prescribed by the healthcare provider.

    The specific dosage and frequency are determined based on individual patient needs and response to treatment.

  5. Step 5

    Ongoing assessments

    Tumor assessments are conducted every 8 weeks for the first 6 months to monitor the disease's response to treatment.

    After the initial 6 months, assessments occur every 12 weeks.

  6. Step 6

    Evaluation of treatment response

    The primary goal is to evaluate the disease control rate after 16 weeks of treatment.

    Secondary evaluations include response rates, overall survival, and quality of life assessments.

  7. Step 7

    Completion of the study

    The study is estimated to conclude by February 28, 2025.

    Final assessments are conducted to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

9 criteria

  • Must be **18 years or older**.
  • Must have a confirmed diagnosis of **neuroendocrine neoplasia NEN G3**. This is a type of cancer that affects certain hormone-producing cells.
  • Must provide a sample of tumor tissue for further testing and research.
  • There should be **no available treatment** that can completely cure the condition.
  • The cancer must have **progressed after at least one round of chemotherapy**. This means the disease has gotten worse despite treatment.
  • Must have a **measurable disease** according to specific medical criteria. This means the cancer can be measured in size to track changes.
  • Must have **adequate organ and bone marrow function**. This means the organs and bone marrow are working well enough to handle the treatment.
  • Must have an **ECOG Performance Status of 0 - 1**. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Must provide **written informed consent**. This means agreeing to participate in the study after understanding all the details and risks.

Who cannot join the trial?

2 criteria

  • Patients with a type of cancer called **small cell lung cancer (SCLC)** cannot participate. This is a specific kind of lung cancer.
  • Patients with **Merkel cell carcinomas** are also excluded. This is a rare type of skin cancer.
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Investigated drugs

  • Cabozantinib

    is a medication used in this trial to treat patients with advanced neuroendocrine neoplasias G3 (NEN G3) who have not responded to standard chemotherapy. It works by blocking certain proteins that promote cancer cell growth, helping to slow down or stop the progression of the disease.

  • Avelumab

    is another medication used in this trial, both on its own and in combination with Cabozantinib. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. This medication is used to improve the body's natural defenses against cancer, aiming to control the disease in patients with NEN G3.

What is already known about the treatment

  • Cabozantinib

    This medication is administered orally and is currently being studied in combination with Avelumab for its effectiveness in treating advanced neuroendocrine neoplasias G3. It is classified as a tyrosine kinase inhibitor and works by blocking certain proteins that promote tumor growth and blood vessel formation. Cabozantinib is primarily used in cancer treatment and is well-documented in medical literature for its role in managing various types of tumors.

  • Avelumab

    This medication is given as an intravenous infusion and is being evaluated in combination with Cabozantinib for patients with advanced neuroendocrine neoplasias G3. Avelumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells by blocking the PD-L1 protein. It is used in cancer therapy and is recognized in medical literature for its application in treating different cancers.

Investigated diseases

Advanced Neuroendocrine Neoplasias G3 (NEN G3) – This disease is a type of cancer that originates from neuroendocrine cells, which are found throughout the body and have traits of both nerve cells and hormone-producing cells. NEN G3 is characterized by high-grade tumors that tend to grow and spread more rapidly than lower-grade neuroendocrine tumors. These neoplasias can occur in various organs, including the pancreas, gastrointestinal tract, and lungs, but exclude small cell lung cancer (SCLC) and Merkel cell carcinomas. As the disease progresses, patients may experience symptoms related to the location of the tumor, such as abdominal pain, weight loss, or hormonal imbalances. The progression of NEN G3 is typically monitored through regular imaging and assessments to evaluate tumor growth and response to treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513518-37-00Protocol codeCaboAveNECEstimated enrolment30 patientsSponsorUniversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

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