Study on Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Liver, Colon, Pancreatic, Bile Duct, Gallbladder, Endometrial, or Esophageal Cancer

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Maastricht Maastricht The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Ctpozhoqr Uffsbeloopihyl Suabckrfj Woluwe-Saint-Lambert Belgium
Lyqvi Uznfewojffvz Mllojoq Cpvuuyu (djsde Leiden The Netherlands
Uoicerufxu Oe Apdvyjw Edegem Belgium
Httixgze Uwxyhidtllhyx Hqwrsvmv Toimk y Pkmybx Idwovvld Clsjou dryairhccbvvwzwbk (fvri Badalona Spain
Hzuwpvuj Vxpk dhcacfew Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
17.08.2021
France France
Not recruiting
17.08.2021
Spain Spain
Not recruiting
17.08.2021
The Netherlands The Netherlands
Not recruiting
17.08.2021

Trial locations

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.

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 ID:
2023-503905-12-00
Protocol code:
MK-6482-016
Trial Phase:
Therapeutic exploratory (Phase II)

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