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Study on Atezolizumab 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 clinical trial is focused on studying the effects of a treatment for locally advanced cervical cancer. The treatment being tested is called atezolizumab, which is also known by its code name RO5541267. Atezolizumab is a type of medication known as a monoclonal antibody, which is a protein designed to help the immune system fight cancer. In this study, atezolizumab is being added to the usual treatment of chemoradiotherapy, which combines chemotherapy and radiation therapy, to see if it can improve outcomes for patients with this type of cancer.

The purpose of the study is to evaluate the benefits of adding atezolizumab to the standard treatment for cervical cancer. Participants in the study will be randomly assigned to receive either the standard chemoradiotherapy alone or chemoradiotherapy with atezolizumab. The study will monitor how well the cancer responds to the treatment and how long patients remain free from cancer progression. The study will also look at overall survival rates and any side effects that may occur during and after the treatment.

Throughout the study, participants will receive regular assessments to track the progress of their cancer and any potential side effects. These assessments will include imaging tests like MRI to measure the size of the cancer and determine if it is responding to the treatment. The study aims to provide valuable information on whether adding atezolizumab to the standard treatment can offer better outcomes for patients with locally advanced cervical cancer.

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, the patient will be required to provide a signed informed consent. This indicates understanding and agreement to participate in the trial.

    A negative serum pregnancy test result is necessary within 7 days before starting the study medication.

  2. Step 2

    Initial treatment phase

    The patient will receive standard chemoradiotherapy (CRT) combined with the medication atezolizumab. Atezolizumab is administered as an intravenous (IV) infusion.

    The medication used is called Tecentriq, which is a 1,200 mg concentrate for solution for infusion.

  3. Step 3

    Concurrent treatment

    During this phase, atezolizumab is given concurrently with CRT. This means both treatments are administered at the same time to enhance effectiveness.

  4. Step 4

    Adjuvant treatment phase

    After the concurrent treatment phase, atezolizumab will continue to be administered as an adjuvant treatment. This phase aims to prevent cancer recurrence after the initial treatment.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to treatment will be closely monitored. This includes regular assessments to evaluate progression-free survival and overall survival.

    The trial will also assess the complete response rate at 8 weeks, locoregional control, and distant tumor control.

  6. Step 6

    End of trial

    The trial is estimated to conclude by May 12, 2025. At this point, final evaluations will be conducted to determine the outcomes of the treatment.

Who can join the trial?

12 criteria

  • The patient must sign an informed consent form after being informed about the study.
  • The patient must have the ability to attend follow-up appointments required by the study.
  • Women who are not postmenopausal (not having periods for 12 months or more) and not surgically sterile must agree to use an acceptable method of birth control or remain abstinent (not have sexual intercourse) during the treatment and for a certain period after the last dose of medication. They must also have a negative pregnancy test before starting the study.
  • The patient must be part of a social security system or have similar benefits, as required by local regulations.
  • The patient must be 18 years or older. Patients over 70 will be screened using a specific tool, and if needed, will consult with a specialist to confirm eligibility.
  • The patient must have a confirmed diagnosis of cervical cancer, specifically squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
  • The patient must have at least one measurable tumor lesion according to specific criteria, with certain size requirements.
  • The cancer must be classified according to specific stages, confirmed by clinical examination and/or imaging tests. Certain stages and conditions are required for eligibility.
  • The patient must have a performance status of 0 or 1, which means they are fully active or have some restrictions but can still carry out light work.
  • The patient must have adequate blood and organ function, as shown by specific laboratory test results taken within 15 days before starting the study treatment.
  • The patient must have protein levels in urine below a certain threshold, but those with a ureteral stent or bladder invasion may still be eligible if levels are higher.
  • The patient must be able to follow the study protocol.

Who cannot join the trial?

2 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who are not considered part of a vulnerable population cannot participate in the study.
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Investigated drugs

  • Atezolizumab

    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. In this study, atezolizumab is being tested to see if it can improve the effectiveness of standard treatments for cervical cancer when used alongside them.

  • Chemoradiotherapy (CRT)

    is a combination of chemotherapy and radiation therapy. This standard treatment is used to kill cancer cells and shrink tumors. In this trial, CRT is used as a baseline treatment to compare the effects of adding atezolizumab.

What is already known about the treatment

Atezolizumab – Atezolizumab is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its effectiveness in treating locally advanced cervical cancer. The main therapeutic indication for atezolizumab is to enhance the body's immune response against cancer cells by blocking the PD-L1 protein, which can help the immune system recognize and attack cancer cells more effectively. At the molecular level, it works as an immune checkpoint inhibitor, specifically targeting the PD-L1 protein to prevent it from binding to its receptor, PD-1, on T-cells. This medication is classified pharmacologically as a monoclonal antibody used in cancer immunotherapy.

Investigated diseases

Locally advanced cervical cancer – This is a stage of cervical cancer where the disease has spread beyond the cervix but has not yet reached distant parts of the body. It typically involves the tissues surrounding the cervix and may extend to the pelvic wall or lower part of the vagina. The progression of this cancer can lead to symptoms such as abnormal vaginal bleeding, pelvic pain, or pain during intercourse. As the disease advances, it may affect nearby organs, such as the bladder or rectum. The growth of the cancer can be influenced by factors like the type of human papillomavirus (HPV) infection and the individual's immune response. Early detection and monitoring are crucial for managing the progression of this condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515533-15-00Protocol codeCSET N°2017/2608Estimated enrolment189 patientsSponsorInstitut Gustave Roussy

sourced from the EU Clinical Trials Register and site verification

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