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Study on Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Liver, Colon, Pancreatic, Bile Duct, Gallbladder, Endometrial, or 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 the effects of a combination of medications on several types of cancer, including liver cancer, colon cancer, pancreatic cancer, bile duct or gallbladder cancer, endometrial cancer, and esophageal cancer. The treatment being tested includes three medications: Pembrolizumab, also known by its code name MK-3475, which is given as an infusion into a vein; Lenvatinib, known as MK-7902, which is taken as a capsule by mouth; and Belzutifan, known as MK-6482, which is taken as a tablet by mouth. These medications are being studied together to see how well they work and how safe they are when used in combination.

The purpose of this study is to evaluate the safety and effectiveness of these medications when used together. Participants in the study will receive the combination of these medications and will be monitored for any side effects and how their cancer responds to the treatment. The study will take place over a period of time, during which participants will have regular check-ups and assessments to track their progress. The study aims to understand how well the combination of these medications can help in treating the different types of cancer mentioned.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how the treatment affects their cancer. The study will help researchers learn more about the potential benefits and risks of using Pembrolizumab, Lenvatinib, and Belzutifan together, which could lead to new treatment options for patients with these types of cancer in the future.

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 tumor sample may be required, either from previous tests or a new biopsy, to verify the type of cancer.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of three medications: lenvatinib, pembrolizumab, and belzutifan.

    Lenvatinib is taken orally in the form of capsules.

    Pembrolizumab is given through an intravenous infusion, which means it is administered directly into a vein.

    Belzutifan is also taken orally as film-coated tablets.

  3. Step 3

    Ongoing treatment and monitoring

    The treatment continues with regular administration of the medications as prescribed by the study protocol.

    Regular monitoring is conducted to assess the response to treatment and to check for any side effects. This includes physical exams, blood tests, and imaging studies.

  4. Step 4

    Evaluation of response

    The effectiveness of the treatment is evaluated using specific criteria to measure tumor response.

    This evaluation is done by independent reviewers to ensure objectivity.

  5. Step 5

    Completion of treatment

    The treatment phase concludes as per the study's timeline or if the patient experiences significant side effects.

    A final assessment is conducted to evaluate the overall response to the treatment.

Who can join the trial?

12 criteria

  • The patient must have a diagnosis of one of the following advanced cancers: **Liver cancer**, **Colon cancer**, **Pancreatic cancer**, **Bile Duct or Gallbladder cancer**, **Endometrial cancer**, or **Esophageal cancer**.
  • The patient must have a type of cancer that cannot be removed by surgery or has spread to other parts of the body.
  • The patient must have a tumor that can be measured by doctors using specific guidelines.
  • The patient must provide a sample of their tumor tissue, either from a previous test or a new biopsy.
  • For **Esophageal cancer**: The patient must have had their cancer get worse after one previous treatment or after treatment with specific immune therapies.
  • For **Liver cancer**: The patient must not have had any previous chemotherapy or certain other cancer treatments.
  • For **Colon cancer**: The patient must have had at least two previous treatments that included specific drugs.
  • For **Pancreatic cancer**: The patient must have had one or two previous treatments that included specific drugs.
  • For **Bile Duct or Gallbladder cancer**: The patient must have had at least one previous treatment that included specific drugs.
  • For **Endometrial cancer**: The patient must be receiving their first treatment for advanced cancer and should not have had previous chemotherapy, with some exceptions related to past treatments.
  • The patient must be at least 18 years old.
  • Both male and female patients can participate.

Who cannot join the trial?

1 criterion

  • Patients with **liver cancer**, **colon cancer**, **pancreatic cancer**, **bile duct or gallbladder cancer**, **endometrial cancer**, or **esophageal cancer** cannot participate.
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Investigated drugs

  • Pembrolizumab

    is a medication that helps the 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. It is used in this trial to evaluate its effectiveness in treating multiple solid tumors.

  • Lenvatinib

    is a medication that targets certain proteins involved in the growth of cancer cells. By inhibiting these proteins, lenvatinib can help slow down or stop the growth of tumors. In this trial, it is used in combination with other medications to assess its role in treating solid tumors.

  • Belzutifan

    is a medication that works by inhibiting a protein that helps cancer cells survive in low-oxygen environments. By blocking this protein, belzutifan can make it harder for cancer cells to grow and spread. This trial is testing its effectiveness when used alongside pembrolizumab and lenvatinib in treating various solid tumors.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently used in clinical trials to treat various types of cancer, including liver, colon, pancreatic, bile duct, gallbladder, endometrial, and esophageal cancers. Pembrolizumab is a monoclonal antibody that works by blocking a specific protein on immune cells, allowing the immune system to better attack cancer cells. It is classified as an immune checkpoint inhibitor and is widely studied in medical literature for its role in cancer immunotherapy.

  • Lenvatinib

    Administered orally, lenvatinib is being tested in combination with other drugs for its effectiveness in treating several solid tumors. It is an approved medication that targets specific proteins involved in cancer cell growth and blood vessel formation, thereby inhibiting tumor growth. Lenvatinib is classified as a tyrosine kinase inhibitor and is recognized in medical literature for its application in cancer treatment.

  • Belzutifan

    This medication is taken orally and is currently under investigation in clinical trials for its potential to treat various solid tumors. Belzutifan works by inhibiting a protein that helps cancer cells survive in low-oxygen environments, which is common in tumors. It is classified as a hypoxia-inducible factor inhibitor and is gaining attention in medical research for its novel approach to cancer therapy.

Investigated diseases

  • Liver cancer

    This disease involves the growth of malignant cells in the liver, which can disrupt its normal functions. It often begins as a small tumor that can grow and spread to other parts of the body. The progression can lead to symptoms such as weight loss, loss of appetite, and jaundice.

  • Colon cancer

    This type of cancer starts in the colon or rectum, part of the digestive tract. It typically begins as small, benign clumps of cells called polyps, which can become cancerous over time. As it progresses, it may cause changes in bowel habits, blood in the stool, and abdominal discomfort.

  • Pancreatic cancer

    This cancer originates in the tissues of the pancreas, an organ that lies behind the lower part of the stomach. It often progresses silently, with symptoms appearing only in advanced stages. These symptoms can include jaundice, weight loss, and abdominal pain.

  • Bile duct or gallbladder cancer

    This disease affects the bile ducts or gallbladder, which are involved in the storage and transport of bile. It can cause symptoms like jaundice, abdominal pain, and nausea as it progresses. The cancer can spread to nearby organs and tissues.

  • Endometrial cancer

    This cancer begins in the lining of the uterus, known as the endometrium. It often presents with abnormal vaginal bleeding, especially after menopause. As it progresses, it may cause pelvic pain and other symptoms.

  • Esophageal cancer

    This type of cancer occurs in the esophagus, the tube that carries food from the throat to the stomach. It can cause difficulty swallowing, weight loss, and chest pain as it advances. The cancer may spread to nearby lymph nodes and other organs.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503905-12-00Protocol codeMK-6482-016Estimated enrolment254 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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