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Study of Pembrolizumab and Lenvatinib for Patients with Advanced or Recurrent Endometrial 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 treatments for endometrial carcinoma, which is a type of cancer that begins in the lining of the uterus. The study is comparing the effectiveness of a combination of two medications, pembrolizumab (also known by its code name MK-3475) and lenvatinib (code name MK-7902), against standard chemotherapy treatments. Pembrolizumab is a type of medication that helps the immune system fight cancer, while lenvatinib is used to slow down the growth of cancer cells. The purpose of the study is to see how well these medications work together in treating advanced or recurrent endometrial carcinoma.

Participants in the study will receive either the combination of pembrolizumab and lenvatinib or chemotherapy. The study will monitor how long participants live without the cancer getting worse and overall survival rates. The study will also look at the quality of life of participants and any side effects they may experience. The medications will be given in different forms: pembrolizumab is administered through an intravenous infusion, which means it is given directly into a vein, while lenvatinib is taken orally in capsule form.

The study will take place over a period of time, with regular check-ups and assessments to track the progress of the treatment. Participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how the treatments are working. The goal is to find out if the combination of pembrolizumab and lenvatinib can provide a better treatment option for people with advanced or recurrent endometrial carcinoma compared to traditional chemotherapy.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A sample of tumor tissue is required to determine specific characteristics of the cancer.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: the pembrolizumab plus lenvatinib group or the chemotherapy group.

    This process ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment administration

    For those in the pembrolizumab plus lenvatinib group, pembrolizumab is administered as an intravenous infusion. Lenvatinib is taken orally in capsule form.

    Participants in the chemotherapy group receive a combination of drugs, including paclitaxel and carboplatin, both administered through intravenous infusion.

    The specific dosage and frequency of administration are determined by the study protocol and the participant's health status.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes imaging tests and laboratory evaluations.

    Participants are required to attend scheduled follow-up visits to track progress and adjust treatment as necessary.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.

    Participants may continue to be monitored for long-term outcomes and any late-occurring side effects.

Who can join the trial?

7 criteria

  • The participant must have **advanced or recurrent endometrial carcinoma**. This means the cancer has come back or spread to other parts of the body.
  • The participant must have **Stage III, Stage IV, or recurrent endometrial carcinoma** confirmed by a test called a biopsy. The cancer must be visible on scans, even if it can't be measured.
  • The participant must provide a **tumor tissue sample**. This can be an old sample or a new one from a biopsy, which is a procedure to take a small piece of the tumor for testing.
  • The participant must have an **ECOG performance status of 0 or 1**. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • The participant must not be **pregnant or breastfeeding**. If the participant is a woman who can have children, she must agree to use birth control during the study and for a certain time after the study drugs are stopped.
  • The participant must have **controlled blood pressure**. This means their blood pressure is at a safe level.
  • The participant must have **adequate organ function**. This means their organs, like the liver and kidneys, are working well enough to handle the study treatment.

Who cannot join the trial?

8 criteria

  • Participants who have a different type of cancer other than advanced or recurrent endometrial carcinoma.
  • Participants who are not within the specified age range for the study.
  • Participants who are not able to follow the study procedures or attend the required visits.
  • Participants who have a medical condition that the study doctors believe would make it unsafe for them to participate.
  • Participants who are currently pregnant or breastfeeding.
  • Participants who have received certain treatments or medications that are not allowed in the study.
  • Participants who have a history of certain medical conditions that could interfere with the study results.
  • Participants who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

  • Pembrolizumab

    This medication is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. In this trial, pembrolizumab is used in combination with another drug to treat advanced or recurrent endometrial carcinoma.

  • Lenvatinib

    This is a targeted therapy drug that interferes with the growth of cancer cells by blocking certain proteins that promote the development of blood vessels needed by tumors to grow. Lenvatinib is used alongside pembrolizumab in this study to enhance the treatment of advanced or recurrent endometrial carcinoma.

  • Chemotherapy

    This treatment uses drugs to kill or stop the growth of cancer cells. In this trial, chemotherapy serves as a comparison to the combination of pembrolizumab and lenvatinib, helping to evaluate the effectiveness of the new treatment approach for advanced or recurrent endometrial carcinoma.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently used in clinical trials for treating advanced or recurrent endometrial carcinoma. It is an established immunotherapy drug that works by blocking a protein called PD-1 on the surface of immune cells, thereby enhancing the body's immune response against cancer cells. Pembrolizumab is classified as a monoclonal antibody and is widely recognized in medical literature for its role in cancer treatment.

  • Lenvatinib

    This medication is taken orally and is being studied in combination with pembrolizumab for the treatment of advanced or recurrent endometrial carcinoma. Lenvatinib is a targeted therapy that inhibits multiple receptor tyrosine kinases involved in tumor growth and angiogenesis, which is the formation of new blood vessels that tumors need to grow. It is classified as a tyrosine kinase inhibitor and is well-documented in medical literature for its effectiveness in various cancers.

Investigated diseases

Endometrial Carcinoma – Endometrial carcinoma is a type of cancer that begins in the lining of the uterus, known as the endometrium. It is most commonly diagnosed in women who have gone through menopause. The disease often presents with symptoms such as abnormal vaginal bleeding or discharge. As it progresses, the cancer can invade the muscular layer of the uterus and may spread to other parts of the body. The progression of the disease can vary, with some cases remaining localized while others may metastasize to distant organs. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505614-17-00Protocol codeMK-7902-001Estimated enrolment911 patientsSponsorMerck Sharp & Dohme LLC

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