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Study on the Effectiveness and Safety of Pembrolizumab, Lenvatinib, and Chemotherapy for Patients with Metastatic Esophageal 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 a type of cancer called metastatic esophageal carcinoma, which is a cancer that starts in the esophagus and has spread to other parts of the body. The study is testing a combination of treatments to see how effective and safe they are for patients with this condition. The treatments being tested include Pembrolizumab (also known by its code name MK-3475), Lenvatinib (code name E7080/MK-7902), and various chemotherapy drugs. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to compare the new combination of treatments with the standard care currently used for this type of cancer. Participants in the study will receive either the new combination of treatments or the standard care. The study will be conducted in two parts. The first part will focus on evaluating the safety of the new treatment combination, while the second part will compare the overall survival of participants receiving the new treatment versus those receiving standard care. The study will involve regular monitoring and assessments to ensure the safety and well-being of participants.

Participants will receive the treatments over a period of time, with some treatments given as an intravenous infusion (a method of delivering medication directly into the bloodstream through a vein) and others taken orally as capsules. The study aims to provide valuable information on whether the new combination of treatments can improve outcomes for patients with metastatic esophageal carcinoma. The trial will also monitor any side effects experienced by participants to ensure the treatments are safe. The study is expected to continue until the end of 2025.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the diagnosis of metastatic esophageal carcinoma.

  2. Step 2

    Treatment plan discussion

    The treatment plan is explained, including the medications involved and their administration methods. The study involves a combination of medications: pembrolizumab, lenvatinib, and chemotherapy drugs such as cisplatin and fluorouracil.

  3. Step 3

    Medication administration

    The treatment involves taking lenvatinib orally in capsule form. Pembrolizumab and chemotherapy drugs like cisplatin and fluorouracil are administered through intravenous infusion. The frequency and dosage are determined by the study protocol and medical team.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes routine check-ups, blood tests, and imaging studies to evaluate the response to the treatment.

  5. Step 5

    Safety and side effects evaluation

    Throughout the study, any side effects or adverse reactions are closely monitored. Adjustments to the treatment may be made based on these observations to ensure patient safety.

  6. Step 6

    Completion of study

    Upon completion of the study, a final assessment is conducted. This includes evaluating the overall response to the treatment and discussing any further steps or follow-up care required.

Who can join the trial?

5 criteria

  • The patient must have a confirmed diagnosis of **metastatic squamous cell carcinoma of the esophagus**. This means that the type of cancer is squamous cell carcinoma, and it has spread to other parts of the body.
  • Male patients must either not engage in heterosexual intercourse or agree to use contraception during the study and for a certain period after the last dose of medication. This is to prevent pregnancy during the study.
  • Female patients must not be pregnant or breastfeeding. If they are capable of becoming pregnant, they must use a highly effective method of contraception or not engage in heterosexual intercourse during the study and for a certain period after the last dose of medication. They must also agree not to donate eggs during this time.
  • The patient must have **adequately controlled blood pressure**. This means their blood pressure should be 150/90 millimeters of mercury (mm Hg) or lower, with no changes in blood pressure medication within one week before starting the study.
  • The patient must have **adequate organ function**. This means their organs, such as the liver and kidneys, are working well enough to participate in the study.

Who cannot join the trial?

14 criteria

  • Patients with any other type of cancer besides Esophageal Carcinoma cannot participate.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer, are excluded.
  • Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, including HIV, hepatitis B, or hepatitis C, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with known allergies to the study drugs or similar drugs are not eligible.
  • Patients who have had major surgery within 4 weeks before starting the study treatment are excluded.
  • Patients who are currently participating in another clinical trial cannot join this study.
  • Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
  • Patients with brain metastases, which are cancer cells that have spread to the brain, are excluded unless they have been treated and are stable.
  • Patients with gastrointestinal conditions that affect the absorption of the study drugs cannot participate.
  • Patients with a history of bleeding disorders or who are taking blood thinners are not eligible.
  • Patients with psychiatric or substance abuse disorders that would interfere with cooperation with the study requirements are excluded.
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Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is being used to see if it can help treat esophageal cancer when combined with other treatments.

  • Lenvatinib

    is a medication that targets specific proteins in cancer cells, which can help slow down or stop the growth of the cancer. It is being tested in this trial to see if it can improve the effectiveness of the treatment for esophageal cancer when used with pembrolizumab and chemotherapy.

  • Chemotherapy

    refers to a group of medications that are used to kill or slow the growth of cancer cells. In this trial, chemotherapy is being used as part of the treatment plan to see if it can help improve outcomes for patients with esophageal cancer when combined with pembrolizumab and lenvatinib.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating metastatic esophageal carcinoma, a type of cancer that affects the esophagus. Pembrolizumab works by helping the immune system recognize and attack cancer cells, specifically by blocking a protein called PD-1 on immune cells, which can prevent them from attacking cancer. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

  • Lenvatinib

    Lenvatinib is taken orally in the form of a capsule, which means it is swallowed and absorbed through the digestive system. It is being evaluated in clinical trials for its role in treating metastatic esophageal carcinoma when used in combination with other treatments. Lenvatinib works by blocking certain proteins that promote the growth of blood vessels in tumors, effectively starving the cancer cells of nutrients and oxygen. It is classified as a tyrosine kinase inhibitor, a type of medication that interferes with specific enzymes involved in cancer cell growth.

Investigated diseases

Esophageal Carcinoma – Esophageal carcinoma is a type of cancer that occurs in the esophagus, the long tube that carries food from the throat to the stomach. It begins in the cells lining the esophagus and can develop into a tumor. As the disease progresses, the tumor can grow and invade deeper layers of the esophagus wall. It may spread to nearby lymph nodes and other organs, such as the liver or lungs. Symptoms often include difficulty swallowing, weight loss, and chest pain. The progression of the disease can lead to obstruction of the esophagus, making it difficult to eat or drink.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501342-29-00Protocol codeMK 7902-014Estimated enrolment877 patientsSponsorMerck Sharp & Dohme LLC

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