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Study on Pembrolizumab, Atezolizumab, and Nivolumab with Carbon Ion Radiotherapy for Patients with Advanced Melanoma, Urothelial Carcinoma, NSCLC, or Head & Neck Cancer

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 the effects of combining immune checkpoint inhibitors with carbon ion radiotherapy in patients with certain types of cancer. The cancers being studied include unresectable or metastatic melanoma, locally advanced or metastatic urothelial carcinoma, locally advanced or metastatic non-small cell lung cancer (NSCLC), and untreated recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The immune checkpoint inhibitors being used in this study are pembrolizumab, atezolizumab, nivolumab, and cemiplimab. These medications are designed to help the immune system recognize and attack cancer cells more effectively.

The purpose of the study is to evaluate how well this combination treatment works in controlling these cancers. Participants will receive the immune checkpoint inhibitors through an intravenous infusion, which means the medication is given directly into a vein. The study will also involve carbon ion radiotherapy, a type of radiation treatment that uses charged particles to target cancer cells. This approach is being tested to see if it can improve the effectiveness of the immune therapy in a palliative setting, which is aimed at relieving symptoms and improving quality of life.

Throughout the study, participants will have regular visits to monitor their health and the response of their cancer to the treatment. This will include imaging tests like CT or MRI scans to measure the size of the tumors and assess any changes. The study will last for a period of time, during which the safety and potential side effects of the treatment will also be closely observed. The goal is to gather information that could lead to better treatment options for these types of cancer in the future.

The research process

The trial runs in 6 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, a signed written informed consent is required. This confirms understanding and agreement to participate in the trial.

    Eligibility is confirmed through a medical assessment, including a review of medical history and current health status.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the presence of at least two measurable target lesions. These lesions will be monitored throughout the study.

    A performance status evaluation is performed to ensure the ability to comply with the study requirements.

  3. Step 3

    Treatment administration

    The treatment involves the administration of **immune checkpoint inhibitors**. These are given through **intravenous use**.

    The specific medications used may include **pembrolizumab**, **atezolizumab**, **nivolumab**, or **cemiplimab**. The choice of medication depends on individual medical conditions and treatment plans.

  4. Step 4

    Carbon ion radiotherapy

    In addition to the immune checkpoint inhibitors, **carbon ion radiotherapy (CIRT)** is administered. This is a type of radiation therapy used to target cancer cells.

    The radiotherapy is applied to at least one of the measurable target lesions identified during the initial assessment.

  5. Step 5

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor the response to treatment. These assessments include imaging tests such as CT or MRI scans.

    The objective response rate is evaluated at least 8 weeks after the completion of carbon ion radiotherapy.

  6. Step 6

    Monitoring and evaluation

    Throughout the trial, the patient's health and any side effects are closely monitored. This includes regular laboratory tests and clinical evaluations.

    The primary focus is on assessing the objective response rate and any potential toxicity according to established criteria.

Who can join the trial?

8 criteria

  • Must provide a signed written informed consent, which means you agree to participate after understanding the study.
  • Must have a confirmed diagnosis of one of the cancers being treated with single-agent anti-PD1/PDL1 immunotherapy. This is a type of treatment that helps your immune system fight cancer.
  • Your disease must be stable, as shown by a monitoring sheet from the Italian drug regulatory agency (AIFA).
  • You need to have at least two measurable target lesions (areas of cancer that can be measured). One of these must be suitable for a special treatment called CIRT.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and complete necessary tests and other study requirements.
  • Both females and males can participate, and you must be 18 years of age or older. There is no upper age limit.
  • Your performance status, which measures your ability to perform daily activities, must be 2 or less on the Eastern Cooperative Oncology Group (ECOG) scale. This means you are up and about more than half of the day.
  • You must have measurable disease by CT or MRI according to RECIST 1.1, which are guidelines for assessing how well the cancer responds to treatment.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer not listed in the study.
  • Patients who have already received treatment for their cancer that is not working.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe heart problems.
  • Patients with uncontrolled infections.
  • Patients with a history of severe allergic reactions to similar treatments.
  • Patients who are unable to follow the study procedures.
  • Patients with a history of another serious illness that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a major surgery within the last 4 weeks.
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Investigated drugs

  • Immune checkpoint inhibitors

    are a type of medication used in cancer treatment. They work by helping the body's immune system recognize and attack cancer cells. Normally, cancer cells can hide from the immune system, but these inhibitors block certain proteins that prevent the immune system from seeing the cancer. This allows the immune system to do its job and fight the cancer more effectively.

  • Carbon ion radiotherapy

    is a special type of radiation treatment that uses carbon ions instead of the usual X-rays. This therapy is more precise and can target cancer cells more accurately, causing less damage to the surrounding healthy tissue. It is particularly useful for treating cancers that are difficult to reach or resistant to conventional radiation therapy. In this trial, carbon ion radiotherapy is combined with immune checkpoint inhibitors to enhance the overall treatment effect.

What is already known about the treatment

Immune checkpoint inhibitors – These medications are typically administered through an intravenous infusion, meaning they are given directly into a vein. They are currently well-established in medical practice and literature as a standard treatment for various cancers, including unresectable or metastatic melanoma, locally advanced or metastatic urothelial carcinoma, non-small cell lung cancer, and untreated recurrent or metastatic head and neck squamous cell carcinoma. The main therapeutic use of immune checkpoint inhibitors is to help the immune system recognize and attack cancer cells more effectively. At the molecular level, they work by blocking certain proteins that prevent the immune system from attacking cancer cells, thus allowing the immune system to target and destroy these cells. These medications are classified as immunotherapy drugs, which are a type of cancer treatment that uses the body's immune system to fight cancer.

Investigated diseases

  • Unresectable or metastatic melanoma

    Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. When melanoma becomes unresectable, it means that it cannot be removed completely through surgery. Metastatic melanoma occurs when the cancer spreads from its original site to other parts of the body, such as the lymph nodes, liver, lungs, or brain. The disease progresses as cancer cells invade nearby tissues and organs, leading to the formation of new tumors. This spread can occur through the lymphatic system or the bloodstream. As the disease advances, it can affect the function of the organs involved.

  • Locally advanced or metastatic urothelial carcinoma

    Urothelial carcinoma is a cancer that originates in the urothelial cells lining the bladder, ureters, and other parts of the urinary tract. When it is locally advanced, the cancer has spread beyond the inner lining of the bladder to nearby tissues or lymph nodes. Metastatic urothelial carcinoma indicates that the cancer has spread to distant organs, such as the liver, lungs, or bones. The progression involves the growth and spread of cancer cells, which can lead to the formation of new tumors in other parts of the body. This spread can occur through the lymphatic system or the bloodstream. As the disease progresses, it can impair the function of affected organs.

  • Locally advanced or metastatic non-small cell lung cancer (NSCLC)

    Non-small cell lung cancer is a group of lung cancers that behave similarly and are the most common type of lung cancer. Locally advanced NSCLC means the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. Metastatic NSCLC indicates that the cancer has spread to distant organs, such as the brain, liver, or bones. The disease progresses as cancer cells grow and invade surrounding tissues, forming new tumors. This spread can occur through the lymphatic system or the bloodstream. As the disease advances, it can affect the function of the organs involved.

  • Untreated recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)

    Head and neck squamous cell carcinoma is a type of cancer that arises from the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, throat, and nose. Recurrent HNSCC refers to cancer that has returned after treatment, while metastatic HNSCC indicates that the cancer has spread to distant parts of the body, such as the lungs or bones. The disease progresses as cancer cells grow and invade nearby tissues, forming new tumors. This spread can occur through the lymphatic system or the bloodstream. As the disease advances, it can impair the function of the affected organs.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517378-22-00Protocol codeCNAO 44 2021CEstimated enrolment27 patientsSponsorFondazione Centro Nazionale Di Adroterapia Oncologica

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