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A study of pembrolizumab and lenvatinib for patients with high risk locally advanced cervical cancer after chemoradiotherapy and brachytherapy

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 involves women with high risk locally advanced cervix cancer, which means the cancer has grown beyond the cervix into nearby tissues but has not spread to distant parts of the body. High risk refers to cases where the cancer is more likely to come back after standard treatment or may not respond as well to usual therapy. The study will use two medications: Keytruda, which contains pembrolizumab, and Lenvatinib. Pembrolizumab works by helping the body's immune system recognize and fight cancer cells, while Lenvatinib is a tyrosine kinase inhibitor that blocks signals cancer cells need to grow and blocks the formation of new blood vessels that tumors need to survive. The purpose of the study is to see how well these treatments work together in preventing the cancer from getting worse or coming back within 24 months after treatment.

Women in this study will first receive standard treatment for their cancer, which includes chemoradiation, a combination of chemotherapy and radiation therapy, along with brachytherapy, a type of internal radiation treatment where the radiation source is placed directly inside or very close to the cancer. During this standard treatment, participants will also begin receiving Keytruda through an intravenous infusion, which means the medication is given directly into a vein. After completing the radiation treatments, there will be an eight-week waiting period to allow the body to recover.

Following the eight-week recovery period, participants will continue receiving Keytruda infusions and will also start taking Lenvatinib capsules by mouth, which means the medication is taken orally. Treatment with Keytruda can continue for up to 24 months, while Lenvatinib can be given for up to 12 months. Throughout the study, doctors will monitor how well the cancer responds to treatment and whether it grows or spreads. The study will track participants to measure the time period during which the cancer does not get worse, which doctors call progression free survival.

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 with chemoradiation and first medication

    Your treatment will begin with chemoradiation, which is a combination of chemotherapy and radiation therapy directed at the affected area.

    During this chemoradiation phase, you will also start receiving pembrolizumab. This medication is given through a vein in your arm (intravenously).

    The chemoradiation treatment will be followed by brachytherapy, which is a type of internal radiation therapy where a radiation source is placed close to or inside the treatment area.

    The entire treatment with chemoradiation and brachytherapy is planned to be completed within 50 days.

  2. Step 2

    Waiting period after brachytherapy

    After your last brachytherapy session is completed, there will be a waiting period of 8 weeks.

    This time allows your body to recover before starting the next phase of treatment.

  3. Step 3

    Combined medication treatment phase

    Eight weeks after your last brachytherapy, you will begin treatment with two medications: pembrolizumab and lenvatinib.

    Pembrolizumab will continue to be given through a vein in your arm (intravenously).

    Lenvatinib is taken by mouth (orally).

    This combined medication treatment will continue for a period of time as determined by your medical team.

  4. Step 4

    Monitoring and assessment

    Throughout the study, your condition will be monitored using imaging scans to assess how the disease is responding to treatment.

    Your blood pressure will be checked regularly to ensure it remains at acceptable levels (at or below 150/90 mm Hg).

    Blood tests will be performed to monitor your blood cell counts and organ function.

    The study will track your progression-free survival, which means the length of time during and after treatment that the disease does not get worse.

    Your overall health status will be assessed using a scale that measures how the disease affects your daily living abilities.

Who can join the trial?

11 criteria

  • You must be older than 18 years of age
  • You must have a performance status of 0 or 1, which means you are able to carry out normal daily activities with little or no symptoms
  • You must have high-risk locally advanced cervical cancer, which is cancer of the cervix that has spread to nearby tissues but not to distant parts of the body. This includes either: squamous cell type cancer at stage IIIA, IIIB, IIIC1, or IIIC2, or adenocarcinoma or adeno-squamous type cancer at stage IB3 through IIIC2
  • You must have cancer that can be measured on imaging scans at the time of diagnosis
  • You must have adequate blood cell counts and proper functioning of your organs, such as liver and kidneys
  • You must have well-controlled blood pressure, meaning your blood pressure should be at or below 150/90 mm Hg, with or without blood pressure medications
  • You must be planned to receive radical chemoradiation, which is a combination of chemotherapy and radiation therapy, along with MR guided adaptive brachytherapy, which is a type of internal radiation treatment guided by imaging. This treatment should be completed within 50 days
  • Your doctor must determine that you are suitable to start receiving Pembrolizumab during your chemoradiation and brachytherapy treatment, and to start receiving Lenvatinib and Pembrolizumab 8 weeks after your last brachytherapy session
  • If you have Hepatitis B and test positive for the virus, you must have been on antiviral treatment for at least 4 weeks and have no detectable virus in your blood before joining the study. You must continue this treatment throughout the study
  • If you have a history of Hepatitis C, you must have no detectable virus in your blood at the screening visit and must have completed curative antiviral treatment at least 4 weeks before joining the study
  • You must provide written informed consent, which means you agree to participate in the trial after understanding all the information about it

Who cannot join the trial?

6 criteria

  • Men cannot participate in this study because it is only for women
  • Children and young people who have not reached adulthood cannot participate
  • Patients who do not have locally advanced cervical cancer, which means cancer of the cervix that has grown beyond the cervix but has not spread to distant parts of the body
  • Patients who are not considered high-risk, meaning their cancer does not have features that make it more likely to come back or spread
  • Patients who have not received chemoradiation, which is a combination treatment using chemotherapy (medicines that kill cancer cells) and radiation therapy (treatment using high-energy rays)
  • Patients who have not received brachytherapy, which is a type of radiation treatment where radioactive material is placed directly inside or very close to the cancer
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that prevents immune cells from attacking the cancer, allowing your body's natural defenses to better recognize and destroy cancer cells.

  • Lenvatinib

    is a targeted therapy medication that works by blocking the growth of new blood vessels that tumors need to grow and spread. By cutting off the blood supply to cancer cells, this medication helps slow down or stop the growth of the tumor.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is a medication given through an intravenous infusion (directly into a vein) that belongs to a class of drugs called immune checkpoint inhibitors. It works by blocking a protein called PD-1 on immune cells, which helps the body's immune system recognize and attack cancer cells more effectively. This medication is currently approved and widely used in medical practice for treating various types of cancers, including cervical cancer, by helping the immune system fight the disease. In this clinical trial, it is being studied in combination with another medication to treat women with high-risk locally advanced cervical cancer who have received chemotherapy and radiation treatment.

  • Lenvatinib

    Lenvatinib is an oral medication (taken by mouth as a capsule or tablet) that belongs to a group of drugs known as tyrosine kinase inhibitors. It works by blocking certain proteins that help cancer cells grow and also prevents the formation of new blood vessels that tumors need to grow and spread throughout the body. This medication is currently approved for treating several types of cancer and is being investigated in medical research for additional uses. In this clinical trial, it is being tested alongside an immune therapy medication to help treat women with high-risk locally advanced cervical cancer following standard chemotherapy and radiation treatment.

Investigated diseases

Locally Advanced Cervical Cancer – This is a stage of cervical cancer where the disease has grown beyond the cervix into nearby tissues but has not spread to distant parts of the body. The cancer typically extends into the upper part of the vagina or the tissues around the cervix. As the disease progresses, it may involve the pelvic wall or affect nearby organs such as the bladder or rectum. Women with locally advanced cervical cancer often experience symptoms such as abnormal vaginal bleeding, pelvic pain, or discomfort during intercourse. The condition develops when abnormal cells in the cervix continue to grow and invade deeper tissues. Some cases are considered high-risk due to factors such as tumor size, lymph node involvement, or specific cellular characteristics that make the cancer more likely to return after treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506982-73-00Protocol codeEmbrace-III Hi-RiskEstimated enrolment45 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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