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Study of Chemoradiotherapy With or Without Pembrolizumab for Patients With High-Risk, Locally Advanced Cervical Cancer

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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 treatment of locally advanced cervical cancer, which is a type of cancer that occurs in the cervix and has spread to nearby tissues but not to distant parts of the body. The study is investigating the effects of a treatment called pembrolizumab, also known by its code name MK-3475, in combination with chemoradiotherapy. Chemoradiotherapy is a treatment that combines chemotherapy, which uses drugs to kill cancer cells, and radiation therapy, which uses high-energy rays to destroy cancer cells. The trial will compare this combination treatment to chemoradiotherapy with a placebo, which is a substance with no active drug.

The purpose of the study is to determine if adding pembrolizumab to chemoradiotherapy improves outcomes for patients with high-risk, locally advanced cervical cancer. Participants in the study will be randomly assigned to receive either the combination of pembrolizumab and chemoradiotherapy or chemoradiotherapy with a placebo. The study will monitor participants over a period to assess how well the cancer responds to the treatment and to evaluate overall survival rates.

Throughout the study, participants will receive their assigned treatments through intravenous infusion, which means the medication is given directly into a vein. The study aims to provide valuable information on whether pembrolizumab can enhance the effectiveness of standard chemoradiotherapy in treating this type of cervical cancer. Participants will be closely monitored by healthcare professionals to ensure their safety and to track the progress of their treatment.

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

    Enrollment and initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and necessary laboratory tests to ensure adequate organ function.

    A tissue sample from a tumor lesion is required for analysis. This is obtained through a biopsy.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of chemoradiotherapy. This involves the use of cisplatin, which is given through an intravenous infusion. The specific dosage and frequency are determined by the healthcare provider based on individual needs.

    Participants are randomly assigned to receive either pembrolizumab or a placebo. Pembrolizumab is administered as an intravenous infusion. The dosage is 25 mg/mL, and the frequency is determined by the study protocol.

  3. Step 3

    Ongoing treatment and monitoring

    Throughout the treatment period, regular monitoring is conducted to assess the response to therapy. This includes imaging studies and laboratory tests to evaluate disease progression and overall health.

    Participants are monitored for any side effects or adverse events. Adjustments to the treatment plan may be made based on these findings.

  4. Step 4

    Completion of treatment

    Upon completion of the treatment regimen, a final assessment is conducted. This includes imaging studies and laboratory tests to evaluate the overall response to the treatment.

    Participants are provided with follow-up care instructions and are monitored for any long-term effects of the treatment.

  5. Step 5

    Follow-up period

    After the treatment phase, a follow-up period is initiated. This involves regular check-ups to monitor health status and detect any recurrence of the disease.

    The follow-up period is designed to ensure ongoing support and management of any health issues that may arise post-treatment.

Who can join the trial?

9 criteria

  • The patient must have **high-risk locally advanced cervical cancer**. This means the cancer is in an advanced stage but has not spread to distant parts of the body.
  • The patient must have a specific type of cervical cancer confirmed by a lab test. These types include **squamous cell carcinoma**, **adenocarcinoma**, or **adenosquamous carcinoma**.
  • The patient must not have received any major surgery, radiation, or drug treatment for cervical cancer before, and must not have had any **immunotherapy** (a treatment that helps the immune system fight cancer).
  • Female patients must not be pregnant or breastfeeding. They must agree to use very effective birth control during the study and for a certain time after the study ends. They also agree not to donate or store eggs for future use during this time.
  • Female patients must not breastfeed during the study and for a certain time after the study ends.
  • The patient must have a good **performance status**. This means they are fully active or can carry out light work, as assessed by a standard scale used by doctors.
  • The patient must provide a sample of their tumor from a biopsy, which is a procedure to remove a small piece of tissue for testing.
  • The patient must have a disease that can be evaluated by imaging tests, as determined by the study doctor or radiologist.
  • The patient must have **adequate organ function**. This means their organs, like the liver and kidneys, are working well enough to handle the treatment.

Who cannot join the trial?

3 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have locally advanced cervical cancer cannot participate. This means the cancer is in the cervix and may have spread to nearby tissues but not to distant parts of the body.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are at higher risk, are not eligible.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to help the body's immune system fight cancer cells. It is a type of immunotherapy that works by blocking a specific protein on cancer cells, allowing the immune system to better detect and destroy them. In this study, pembrolizumab is being tested in combination with chemoradiotherapy to see if it improves outcomes for patients with high-risk, locally advanced cervical cancer.

  • Chemoradiotherapy

    is a combination of chemotherapy and radiation therapy used to treat cancer. Chemotherapy uses drugs to kill cancer cells or stop them from growing, while radiation therapy uses high-energy rays to target and destroy cancer cells. In this trial, chemoradiotherapy is being used as a standard treatment for cervical cancer, and its effectiveness is being compared with and without the addition of pembrolizumab.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered intravenously, typically as an infusion. It is currently being studied in clinical trials for its effectiveness in treating high-risk, locally advanced cervical cancer. The main therapeutic indication for pembrolizumab in this context is to improve progression-free survival and overall survival when used alongside chemoradiotherapy. At the molecular level, pembrolizumab works by blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Locally Advanced Cervical Cancer – This is a stage of cervical cancer where the disease has spread beyond the cervix to nearby tissues but not to distant parts of the body. It often involves the pelvic wall or the lower part of the vagina. The cancer may also affect nearby lymph nodes. Symptoms can include abnormal vaginal bleeding, pelvic pain, or pain during intercourse. As the disease progresses, it may cause more severe symptoms and affect additional areas within the pelvis. The progression of the disease can vary, and it may require ongoing monitoring and evaluation.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501972-25-00Protocol codeMK-3475-A18Estimated enrolment712 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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