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Study of cemiplimab with chemoradiotherapy for patients with locally advanced cervical 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 study examines locally advanced cervical carcinoma, which is a type of cancer that affects the cervix and has grown beyond the early stages but has not spread to distant parts of the body. The study will use cemiplimab, which is a medication that helps the body's immune system fight cancer cells, in combination with standard treatment. The standard treatment includes chemoradiotherapy, which is a combination of chemotherapy using the drug cisplatin and radiation therapy. Chemotherapy involves using medications to kill cancer cells, while radiation therapy uses high-energy rays to destroy cancer cells. The study will give cemiplimab both before and after the standard chemoradiotherapy treatment.

The purpose of this study is to evaluate how well cemiplimab works when given before and after standard chemoradiotherapy in patients with locally advanced cervical carcinoma by measuring how many patients respond to the treatment. During the study, patients will first receive cemiplimab treatment, then undergo the standard chemoradiotherapy with cisplatin and radiation, and finally continue with cemiplimab treatment for a maintenance period. The cemiplimab will be given through an infusion into a vein, which means the medication is delivered directly into the bloodstream through a needle placed in a vein. The cisplatin will also be given through infusion into a vein during the chemoradiotherapy phase.

The study will measure whether the cancer shrinks or disappears completely after treatment, how long patients live without the cancer getting worse, and overall survival. It will also examine how the treatment affects quality of life and will monitor for any side effects that may occur during treatment. Additionally, the study will collect tissue samples to look at biological markers that might help predict which patients will respond best to the treatment. Patients will be followed for several years to assess the long-term effectiveness of this treatment approach.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase with cemiplimab

    At the start of the trial, you will receive cemiplimab, which is a type of immunotherapy medication that helps your immune system fight cancer cells.

    The medication will be given through intravenous infusion, meaning it will be administered directly into your vein over a period of time.

    The product used is LIBTAYO 350 mg concentrate for solution for infusion.

    This initial treatment phase is called the induction phase.

  2. Step 2

    Standard combined treatment with chemotherapy and radiation

    Following the initial treatment, you will receive standard chemoradiotherapy, which is a combination of chemotherapy and radiation therapy.

    The chemotherapy medication used is cisplatin, administered through intravenous infusion.

    The product used is CISPLATINO SANDOZ solution for infusion.

    This combined treatment approach is the standard method for treating locally advanced cervical cancer.

  3. Step 3

    Maintenance treatment with cemiplimab

    After completing the combined chemotherapy and radiation treatment, you will continue receiving cemiplimab as maintenance therapy.

    This medication will continue to be given through intravenous infusion.

    The maintenance treatment is designed to help prevent the cancer from returning or progressing.

  4. Step 4

    Regular monitoring and assessments

    Throughout the trial, your response to treatment will be evaluated using RECIST 1.1 criteria, which is a standardized method for measuring how tumors respond to treatment.

    Your medical team will assess whether the tumor has completely disappeared (complete response) or has decreased in size (partial response).

    Blood tests will be performed regularly to monitor your kidney function, liver function, blood cell counts, and clotting factors.

    Tissue samples from your tumor will be analyzed to understand how the treatment is working.

    Quality of life assessments will be conducted using questionnaires to understand how the treatment affects your daily activities and symptoms.

  5. Step 5

    Long-term follow-up

    After completing all treatment phases, you will continue to be monitored for an extended period.

    The medical team will check for any signs of cancer progression or return.

    This follow-up period may extend for several years to assess the long-term effectiveness of the treatment.

    Any side effects or adverse events will be documented and managed according to CTCAE version 5.0, which is a standard system for grading the severity of side effects.

Who can join the trial?

17 criteria

  • You must read, understand, and sign the informed consent form before any study procedures begin
  • Your tumor must test positive for PD-L1, which is a protein found on cancer cells, with a level of 1% or higher
  • Your cancer must be confirmed by tissue examination to be one of these types: squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
  • You must not have received any previous treatment for cervical cancer, including surgery, radiation therapy, chemotherapy, or experimental drugs, and you must not have received immunotherapy, which is a type of treatment that helps your immune system fight cancer
  • Your ECOG performance status must be 0 or 1, which means you are able to carry out normal activities or have only slight restrictions
  • Your cancer must be measurable according to specific measurement criteria called RECIST 1.1
  • Your kidney function must be adequate, with serum creatinine, a waste product measured in blood, at 1.5 times the upper normal limit or below, or your creatinine clearance, which shows how well your kidneys filter blood, must be 30 mL/min or higher
  • Your serum bilirubin, a substance produced when red blood cells break down, must be 1.5 times the upper normal limit or below, unless you have Gilbert disease, a harmless condition affecting bilirubin processing, in which case it can be up to 3 times the upper normal limit
  • Your liver function tests, including AST, ALT, and alkaline phosphatase, which are enzymes that indicate liver health, must be less than 2.5 times the upper normal limit, or less than 5 times if cancer has spread to your liver or bones
  • Your blood clotting tests, including INR, PT, and aPTT, must be 1.5 times the upper normal limit or below, unless you are taking blood thinning medications and your levels are within the expected range for those medications
  • You must provide a tissue sample from a biopsy of your tumor
  • Your blood counts must be adequate: absolute neutrophil count, a type of white blood cell that fights infection, must be 1500 per microliter or higher; platelets, which help blood clot, must be 100,000 per microliter or higher; and hemoglobin, which carries oxygen in blood, must be 9.0 grams per deciliter or higher
  • You must not be pregnant or breastfeeding, and you must agree to use highly effective birth control during treatment and for at least 120 days after the last dose of the study medication
  • If breastfeeding, you must stop during the study treatment period and for at least 120 days after the last dose of study medication and 180 days after completing chemoradiotherapy
  • You must be older than 18 years of age
  • Your life expectancy must be at least 3 months
  • You must have locally advanced cervical cancer, which means cancer that has grown beyond the cervix but has not spread to distant parts of the body, classified as FIGO 2018 stage IB3-IVA, which is a staging system that describes how far the cancer has spread

Who cannot join the trial?

13 criteria

  • Male patients cannot participate in this study as it is only for female patients
  • Patients who are children or adolescents (under 18 years of age) cannot participate, as the study is only for adults
  • Patients with cervical cancer that is not locally advanced cannot participate, meaning the cancer must be at a specific stage where it has grown beyond the cervix but has not spread to distant parts of the body
  • Patients who have already received treatment for their cervical cancer may not be eligible, as the study is designed to test treatment given before standard therapy
  • Patients who are pregnant or breastfeeding are typically excluded from cancer treatment studies due to potential risks to the baby
  • Patients with other active cancers or a history of recent cancer may not be able to participate
  • Patients with serious medical conditions affecting major organs like the heart, lungs, liver, or kidneys may be excluded if these conditions could interfere with treatment safety
  • Patients with autoimmune diseases, which are conditions where the body's immune system attacks its own tissues, may not be eligible as the study drug affects the immune system
  • Patients who have received immunotherapy (treatments that use the immune system to fight cancer) in the past may be excluded
  • Patients taking medications that suppress the immune system, such as high doses of steroids, may not be able to participate
  • Patients with active infections requiring treatment may need to wait until the infection is resolved
  • Patients with known HIV, hepatitis B, or hepatitis C infections may be excluded depending on the status of these conditions
  • Patients who are allergic to the study medication or its components cannot participate
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Investigated drugs

Cemiplimab is a type of immunotherapy medication that helps your immune system recognize and fight cancer cells. In this trial, it is given both before and after standard chemoradiotherapy treatment to see if it can help shrink tumors in patients with locally advanced cervical cancer.

Standard chemoradiotherapy is a combination treatment that includes chemotherapy (cancer-fighting drugs) and radiotherapy (radiation treatment) given together. This is the usual treatment approach for locally advanced cervical cancer and serves as the foundation of treatment in this study.

What is already known about the treatment

Cemiplimab – Cemiplimab is a medication given through an intravenous infusion (injection into a vein) that belongs to a class of drugs called immune checkpoint inhibitors, specifically targeting a protein called PD-1. It works by blocking the PD-1 protein on immune cells, which helps the body's immune system recognize and attack cancer cells more effectively. This medication is currently approved for treating certain types of skin cancer and lung cancer, and is being studied in clinical trials for cervical cancer when used in combination with standard chemoradiotherapy (a treatment combining chemotherapy and radiation). In this trial, cemiplimab is being tested to see if it can improve treatment outcomes for patients with locally advanced cervical cancer by enhancing the immune system's ability to fight the tumor before and after standard treatment.

Investigated diseases

Locally Advanced Cervical Carcinoma – This is a type of cancer that develops in the cervix, which is the lower part of the uterus that connects to the vagina. The disease occurs when abnormal cells in the cervix begin to grow and multiply uncontrollably. In the locally advanced stage, the cancer has grown beyond the cervix into nearby tissues and structures in the pelvic area, but has not spread to distant parts of the body. The tumor may extend into the upper part of the vagina, the tissues around the cervix, or the lower part of the uterus. As the disease progresses, it can cause symptoms such as abnormal vaginal bleeding, pelvic pain, and discomfort during intercourse. Without intervention, the cancer cells continue to invade surrounding tissues and may eventually spread to lymph nodes in the pelvis or to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521839-36-00Protocol codeCADILLACC TRIALEstimated enrolment29 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

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