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Study on the Safety and Effects of Durvalumab and Tremelimumab with Radiotherapy for Patients with Metastatic Squamous Cell Carcinoma

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 called metastatic squamous cell carcinoma, which can occur in areas such as the head and neck, lungs, esophagus, cervix, vagina, vulva, or anus. The study is testing a combination of treatments to see how safe and effective they are. The treatments being tested include two medications: Durvalumab (also known by its code name MEDI4736) and Tremelimumab. These medications are given together with a type of radiation therapy called stereotactic body radiotherapy (SBRT), which is a precise form of radiation treatment.

The purpose of the study is to evaluate the safety and clinical activity of these treatments when used together. Participants in the study will receive the medications and radiation therapy, and their health will be monitored to see how their cancer responds to the treatment. The study will also look at any side effects that may occur. The trial is divided into two phases: the first phase focuses on safety, while the second phase looks at how well the treatment works in reducing cancer outside the area that receives radiation.

Throughout the study, participants will undergo various medical assessments, including imaging tests like CT scans, to track the progress of their cancer and any changes in their condition. The study aims to provide valuable information on the potential benefits and risks of using Durvalumab and Tremelimumab in combination with SBRT for treating this type of 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

    Initial treatment phase

    The treatment begins with the administration of two medications: tremelimumab and durvalumab. These are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.

    The medications are administered intravenously. The specific dosage and frequency will be determined by the healthcare provider based on the study protocol.

  2. Step 2

    Combination with radiotherapy

    The treatment includes a combination with stereotactic body radiotherapy (SBRT). This is a type of radiation therapy that targets tumors with high precision.

    The radiotherapy is applied to specific tumor sites, while ensuring that at least one tumor site remains unirradiated for comparison purposes.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes evaluating any side effects and the response of the tumors to the treatment.

    Imaging tests, such as CT scans, are used to evaluate the tumors outside the field of radiotherapy.

  4. Step 4

    Follow-up phase

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

    The duration of the follow-up phase is determined by the study protocol and may extend for several months after the last dose of medication.

Who can join the trial?

20 criteria

  • Patients must be **18 years of age or older**.
  • Patients must have **adequate organ function**, which includes:
    • Enough white blood cells called **neutrophils** (at least 1500 per mm3).
    • Enough **platelets** (at least 100,000 per mm3).
    • **Hemoglobin** level greater than 9 g/dL.
    • **Bilirubin** level no more than 1.5 times the normal limit, except for those with **Gilbert's syndrome** (a condition with high bilirubin levels without liver disease).
    • **ALT and AST** (liver enzymes) levels no more than 2.5 times the normal limit, or 5 times if there are liver metastases.
    • **Creatinine clearance** greater than 40 mL/min, which measures kidney function.
    • Patients must not have other serious health conditions that would make the treatment unsafe.
    • Female patients must either be unable to have children or have a negative pregnancy test before starting the study.
    • Men who can father children and women who can become pregnant must use effective birth control during the study and for a certain period after the study.
    • Patients must understand and sign a consent form and be willing to follow study procedures.
    • Patients must have **social security** or be a beneficiary of it.
    • Patients must have a confirmed diagnosis of **metastatic squamous cell carcinoma** in specific areas like the head, neck, or other listed organs, and have been treated before with certain therapies.
    • Patients must have at least one tumor that can be treated with radiation and another that will not be treated with radiation.
    • Patients must have at least one tumor that can be biopsied (sampled) both before and after treatment.
    • Patients must have a previously collected tumor sample available.
    • The tumors must be measurable according to specific criteria (RECIST 1.1).
    • Patients must not have had radiation therapy in the area to be treated.
    • There must be a certain time gap since the last treatment with other medications or therapies before starting the study.
    • Patients must have a **performance status** of 0-1, which means they are fully active or have some restrictions but can still do light work.

Who cannot join the trial?

11 criteria

  • Patients who have had another type of cancer in the past, except for certain skin cancers that have been treated.
  • Patients who have an active infection that requires treatment with antibiotics.
  • Patients who have a history of severe allergic reactions to medications similar to those used in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an autoimmune disease, which is when the body's immune system attacks its own healthy cells.
  • Patients who have received a live vaccine within 30 days before starting the study. A live vaccine contains a small amount of the actual virus or bacteria.
  • Patients who have a condition that affects their ability to understand or follow the study instructions.
  • Patients who have a serious heart condition, such as heart failure or a recent heart attack.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who are currently participating in another clinical trial.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the immune system fight cancer. It works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. By blocking this protein, Durvalumab helps the immune system recognize and destroy cancer cells more effectively.

  • Tremelimumab

    is another medication used in the trial that also helps the immune system target cancer cells. It works by blocking a protein called CTLA-4, which can slow down the immune response. By inhibiting this protein, Tremelimumab enhances the ability of the immune system to attack and kill cancer cells.

  • Stereotactic Body Radiotherapy (SBRT)

    is a type of radiation therapy used in the trial. It delivers high doses of radiation to cancer cells with precision, minimizing damage to surrounding healthy tissue. This therapy is used in combination with the medications to enhance their effectiveness in treating metastatic squamous cell carcinoma.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic squamous cell carcinoma in various body parts, including the head, neck, lung, esophagus, cervix, vagina, vulva, or anus. It is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. Durvalumab is classified as a monoclonal antibody and is being evaluated for its safety and potential to enhance the effects of radiotherapy.

  • Tremelimumab

    Tremelimumab is also administered intravenously and is under investigation in clinical trials for its role in treating metastatic squamous cell carcinoma in conjunction with Durvalumab and stereotactic body radiotherapy (SBRT). It functions by inhibiting the CTLA-4 protein, thereby boosting the immune system's ability to fight cancer. Tremelimumab is a monoclonal antibody and is being assessed for its safety and effectiveness in combination therapies aimed at improving cancer treatment outcomes.

Investigated diseases

  • Metastatic Squamous Cell Carcinoma of the Head and Neck

    This is a type of cancer that begins in the squamous cells lining the head and neck region and has spread to other parts of the body. It typically progresses by invading nearby tissues and can metastasize to distant organs, making it more challenging to manage. The disease often affects areas such as the mouth, throat, and larynx, leading to symptoms like difficulty swallowing and changes in voice.

  • Metastatic Squamous Cell Carcinoma of the Lung

    This cancer originates in the squamous cells of the lung and spreads to other body parts. It progresses by growing into nearby tissues and potentially spreading to distant organs. Symptoms may include persistent cough, chest pain, and shortness of breath as the disease advances.

  • Metastatic Squamous Cell Carcinoma of the Esophagus

    This cancer starts in the squamous cells of the esophagus and spreads to other areas. It progresses by invading surrounding tissues and can metastasize to distant sites. Common symptoms include difficulty swallowing and weight loss as the disease develops.

  • Metastatic Squamous Cell Carcinoma of the Cervix

    This type of cancer begins in the squamous cells of the cervix and spreads to other parts of the body. It progresses by invading nearby tissues and can metastasize to distant organs. Symptoms may include abnormal vaginal bleeding and pelvic pain as the disease advances.

  • Metastatic Squamous Cell Carcinoma of the Vagina

    This cancer originates in the squamous cells of the vagina and spreads to other areas. It progresses by growing into nearby tissues and potentially spreading to distant organs. Symptoms may include vaginal bleeding and discharge as the disease develops.

  • Metastatic Squamous Cell Carcinoma of the Vulva

    This cancer starts in the squamous cells of the vulva and spreads to other parts of the body. It progresses by invading surrounding tissues and can metastasize to distant sites. Common symptoms include itching, pain, and changes in the skin of the vulva as the disease advances.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514920-18-00Protocol codeCSET N°2016/2454Estimated enrolment61 patientsSponsorInstitut Gustave Roussy

sourced from the EU Clinical Trials Register and site verification

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