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A study of belzutifan and lenvatinib for patients with von Hippel-Lindau disease-associated tumors or other specific solid tumors.

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with various types of cancer, including Renal Cell Carcinoma, Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer, Esophageal Squamous Cell Carcinoma, and Pancreatic Neuroendocrine Tumor. It also includes people with Advanced Pheochromocytoma/Paraganglioma, Advanced Gastrointestinal Stromal Tumor, and certain types of Colorectal Cancer, Endometrial Cancer, or Solid Tumors that have specific genetic changes called HIF-2α related genetic alterations. Additionally, the research involves patients with von Hippel-Lindau Disease-Associated Tumors, which are tumors caused by a specific genetic condition. The purpose of the study is to evaluate the long-term effectiveness and safety of certain treatments.

The treatments being studied include belzutifan, which is taken as an oral film-coated tablet, and lenvatinib, which is taken as an oral capsule. Participants in the study will continue their current treatment regimen to monitor how the medications work over a longer period of time. The study will track overall survival, which refers to the length of time patients remain alive, and monitor any adverse events, which are side effects or unexpected medical problems that may occur during the treatment.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    You will take belzutifan, which is provided as a film-coated tablet. the dose is 240 mg and is taken by oral use (swallowing the tablet).

    You will also take lenvatinib, which is provided in capsule form. the dose is 20 mg and is taken by oral use (swallowing the capsule).

  2. Step 2

    Monitoring and evaluation

    The trial focuses on tracking overall survival, which is the length of time a person remains alive during and after the treatment period.

    The effects of the medications are monitored by observing adverse events, which are any unwanted or harmful medical occurrences that happen during the study.

    The study tracks the number of people who must stop the treatment because of these adverse events.

Who can join the trial?

6 criteria

  • You must have advanced solid tumors, which are types of cancer that have spread or grown significantly in different parts of the body.
  • You may have tumors related to von Hippel-Lindau (VHL) disease, which is a genetic condition that causes various types of tumors to grow in different organs.
  • You must be currently taking part in a study that uses a medication called belzutifan.
  • You must be receiving active treatment, meaning you are currently in the middle of your medical therapy, within a main study involving belzutifan.
  • The study is open to both males and females.
  • You must fall within the specific age range required for this study.

Who cannot join the trial?

2 criteria

  • You cannot join if you are experiencing an ongoing serious adverse event, which means a severe or unexpected medical problem caused by a previous study, unless you are no longer in the hospital and your condition is clinically stable, meaning your health is steady and not getting worse.
  • You cannot join if you have had to stop taking your current study medication because of an adverse event, which is a medical term for a side effect or an unwanted reaction to a treatment; however, you may join once you have been able to start that treatment again.
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Investigated drugs

  • Belzutifan

    is an oral tablet used to treat certain types of tumors by targeting the pathways that help these tumors grow and survive.

  • Lenvatinib

    is an oral capsule used to treat cancer by blocking specific proteins that help tumors grow new blood vessels, which can help starve the tumor of the nutrients it needs.

What is already known about the treatment

  • Belzutifan

    This medication is taken orally in the form of a film-coated tablet and is used to treat various tumors associated with von Hippel-Lindau disease. It belongs to a class of drugs known as HIF-2α inhibitors and works by blocking a specific protein that helps cancer cells grow and survive. Currently, it is an approved treatment used to target the molecular pathways that allow these specific tumors to develop.

  • Lenvatinib

    This medicine is administered orally as a capsule and is primarily used to treat several types of advanced cancers, including liver and kidney cancer. It is classified as a multi-kinase inhibitor, which means it works by blocking specific enzymes that help tumors grow new blood vessels to feed themselves. It is an established treatment in medical practice used to slow down the progression of solid tumors.

Investigated diseases

  • Renal cell carcinoma

    This is a type of cancer that starts in the cells of the kidney. It typically begins in the lining of the small tubes within the kidney. The disease can grow into larger masses that may spread to other parts of the body.

  • Hepatocellular carcinoma

    This is a primary type of liver cancer that develops in the main liver cells. It often develops in people with long-term liver damage or scarring. The abnormal cells grow and multiply, forming tumors within the liver tissue.

  • Non-MSI-H/dMMR colorectal cancer

    This refers to cancer of the colon or rectum that does not have specific genetic markers called high microsatellite instability or mismatch repair deficiency. The disease begins in the cells lining the large intestine. It progresses as cells grow uncontrollably and form tumors in the digestive tract.

  • Pancreatic ductal adenocarcinoma

    This is a cancer that originates in the ducts of the pancreas, which are the tubes that carry digestive juices. It is the most common form of pancreatic cancer. The disease starts in the lining of these ducts and spreads through the pancreatic tissue.

  • Biliary tract cancer

    This group of cancers develops in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. The disease can occur in the ducts inside the liver or those outside of it. It progresses as abnormal cells form tumors within the biliary system.

  • Non-MSIH/dMMR endometrial cancer

    This is a type of cancer that starts in the lining of the uterus and lacks specific genetic instability markers. It begins in the endometrial cells. The disease progresses as these cells multiply and expand within the uterine cavity.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524160-38-00Protocol codeMK-6482-043Estimated enrolment563 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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