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Study on the Effectiveness and Safety of Lenvatinib, Pembrolizumab, and Chemotherapy for Patients with Advanced or Metastatic Gastroesophageal Cancer

Fast replyRegistered 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 treatment of advanced or metastatic gastroesophageal adenocarcinoma, a type of cancer that affects the stomach and esophagus. The study will evaluate the effectiveness and safety of a combination of medications, including lenvatinib (also known by the code name E7080/MK-7902), pembrolizumab (known as MK-3475), and chemotherapy. Chemotherapy in this study may include drugs such as calcium folinate, capecitabine, fluorouracil, and oxaliplatin. These medications are used to help stop the growth of cancer cells.

The purpose of the study is to compare the new treatment combination with the standard care currently used for this type of cancer. Participants will receive either the new treatment combination or the standard care, which may include a placebo. The study will be conducted over a period of time, with regular check-ups and assessments to monitor the participants' health and the effectiveness of the treatment. The study aims to determine if the new combination of medications can improve survival rates and delay the progression of the disease compared to the standard treatment.

Participants in the study will receive the medications through different methods, such as oral capsules or intravenous infusions, which involve delivering the medication directly into the bloodstream. The study will also monitor any side effects or adverse reactions to the treatment. By participating in this study, researchers hope to find a more effective treatment option for those suffering from advanced or metastatic gastroesophageal adenocarcinoma.

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

    Upon joining the study, you will begin the initial treatment phase. This involves receiving a combination of medications designed to treat advanced or metastatic gastroesophageal adenocarcinoma.

    You will take lenvatinib orally. The dosage and frequency will be determined by the study team based on your specific needs.

    You will also receive pembrolizumab through an intravenous infusion. This means the medication will be administered directly into your vein over a period of time.

  2. Step 2

    Chemotherapy administration

    In addition to lenvatinib and pembrolizumab, you will receive chemotherapy. This may include medications such as capecitabine, fluorouracil, oxaliplatin, and calcium folinate.

    Capecitabine is taken orally, while fluorouracil, oxaliplatin, and calcium folinate are administered through intravenous infusion.

    The specific combination and schedule of these medications will be explained to you by the study team.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups and tests to assess the effectiveness and safety of the treatment.

    You will be asked to report any side effects or changes in your condition to the study team promptly.

    The study team will provide guidance on managing any side effects and adjusting treatment as necessary.

  4. Step 4

    Completion of treatment

    At the end of the treatment period, you will undergo a final evaluation to determine the overall impact of the treatment on your condition.

    The study team will discuss the results with you and provide recommendations for any further care or follow-up needed.

    Your participation in the study will contribute to understanding the effectiveness and safety of the treatment for future patients.

Who can join the trial?

9 criteria

  • The patient must have a confirmed diagnosis of advanced or metastatic gastroesophageal adenocarcinoma, which means the cancer has spread and cannot be removed by surgery.
  • The patient should not need surgery to remove the tumor during the study.
  • The patient's cancer must not be **HER-2/neu positive**, which is a specific protein that can affect cancer growth.
  • The patient must have measurable disease, which means the cancer can be measured using a scan with IV contrast, as determined by the study doctor.
  • Male patients must agree not to donate sperm and either avoid heterosexual intercourse or use contraception during the study and for a certain period after the last dose of medication.
  • Female patients who are not pregnant or breastfeeding can participate if they are not able to have children, or if they can have children, they must use effective contraception or avoid heterosexual intercourse, and not donate eggs or breastfeed during the study and for a certain period after the last dose of medication.
  • The patient must have a performance status of 0 or 1 on the **Eastern Cooperative Oncology Group (ECOG) Performance Scale**, which is a measure of how well they can perform daily activities.
  • The patient must have controlled blood pressure, with or without medication.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.

Who cannot join the trial?

11 criteria

  • Patients with other types of cancer that are not **advanced/metastatic gastroesophageal adenocarcinoma** cannot participate.
  • Patients who have had a different cancer treatment within the last 28 days are excluded.
  • Patients with severe 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 a history of severe allergic reactions to similar drugs are not eligible.
  • Patients with brain metastases that are causing symptoms are excluded.
  • Patients who have had major surgery within the last 4 weeks cannot join the study.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
  • Patients who are currently participating in another clinical trial are excluded.
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Investigated drugs

  • Lenvatinib

    is a medication used in this trial to help treat advanced or metastatic gastroesophageal adenocarcinoma. It works by blocking certain proteins that promote the growth of cancer cells, which may help slow down or stop the progression of the disease.

  • Pembrolizumab

    is another medication involved in the trial. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. By enhancing the immune response, pembrolizumab can help control the growth of cancer.

  • Chemotherapy

    refers to the use of drugs to kill or stop the growth of cancer cells. In this trial, chemotherapy is used in combination with lenvatinib and pembrolizumab to provide a comprehensive approach to treating the cancer. Chemotherapy targets rapidly dividing cells, which include cancer cells, and can help reduce the size of tumors or slow their growth.

What is already known about the treatment

  • Lenvatinib

    Lenvatinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness and safety in treating advanced or metastatic gastroesophageal adenocarcinoma. The main therapeutic indication for lenvatinib is its use in combination with other treatments for certain types of cancer. At the molecular level, lenvatinib works by blocking specific proteins that promote the growth of cancer cells, thereby inhibiting tumor growth. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

  • Pembrolizumab

    Pembrolizumab is administered through intravenous infusion. It is being evaluated in clinical trials for its role in treating advanced or metastatic gastroesophageal adenocarcinoma. The primary therapeutic indication for pembrolizumab is its use in combination with other treatments to enhance the body's immune response against cancer cells. At the molecular level, pembrolizumab works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Advanced/Metastatic Gastroesophageal Adenocarcinoma – This disease is a type of cancer that originates in the glandular cells of the stomach and esophagus. It is characterized by the abnormal growth of cells in the lining of these organs, which can form tumors. As the disease progresses, it can spread beyond the stomach and esophagus to other parts of the body, such as the liver, lungs, and lymph nodes. The spread of cancer to distant organs is referred to as metastasis. Symptoms may include difficulty swallowing, weight loss, and abdominal pain. The progression of the disease can lead to complications affecting digestion and overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504834-23-00Protocol codeMK-7902-015Estimated enrolment890 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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