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

3 1 1

What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
University Hospital Maastricht Maastricht The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Orszagos Onkologiai Intezet Budapest Hungary
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Isala Klinieken Stichting Zwolle The Netherlands
Hospital Universitario 12 De Octubre Madrid Spain
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
University Hospital Olomouc Olomouc Czechia
Pirkanmaan hyvinvointialue Tampere Finland
Netherlands Cancer Institute Amsterdam The Netherlands
Hotgty Hmanymmo Herlev Denmark
Hkasiqwl Ucaqhzweiv Cbreweb Hkujszgv Helsinki Finland
Uoeftgmvvlqesu Csgxjbl Knpsvvizq Gdansk Poland
Hevtqhth Vheb dwfpkbgo Barcelona Spain
Hiynqbue Uguafuhwpqwhta Sqytuklkfc &ufjymr Hcnukeu df Hbqtogtyrqg STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.05.2026
Czechia Czechia
Recruiting
01.05.2026
Denmark Denmark
Not yet recruiting
01.05.2026
Finland Finland
Recruiting
01.05.2026
France France
Not yet recruiting
01.05.2026
Germany Germany
Not yet recruiting
01.05.2026
Hungary Hungary
Recruiting
01.05.2026
Poland Poland
Not yet recruiting
01.05.2026
Spain Spain
Recruiting
01.05.2026
The Netherlands The Netherlands
Recruiting
01.05.2026

Trial locations

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.

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.

Esophageal squamous cell carcinoma – This is a cancer that forms in the squamous cells, which are the flat cells lining the esophagus. The esophagus is the tube that connects the throat to the stomach. The disease develops when these cells undergo abnormal changes and form growths.

Advanced Pheochromocytoma/Paraganglioma – These are tumors that arise from specialized cells that produce hormones. Pheochromocytomas develop in the adrenal glands, while paragangliomas develop in other parts of the nervous system. The disease involves the uncontrolled growth of these cells and the potential overproduction of hormones.

Pancreatic neuroendocrine tumor – This is a type of cancer that begins in the hormone-producing cells of the pancreas. Unlike common pancreatic cancers, these arise from neuroendocrine cells. The disease progresses as these specific cells form tumors within the pancreatic organ.

von Hippel-Lindau disease-associated tumors – These are various tumors that occur in individuals with a specific genetic condition. The tumors can develop in many different organs, such as the kidneys, brain, or pancreas. The disease is characterized by the development of multiple abnormal growths due to genetic factors.

Advanced Gastrointestinal Stromal Tumor – This is a type of cancer that develops in the digestive tract, most commonly in the wall of the stomach or small intestine. It arises from specialized cells called interstitial cells of Cajal. The disease progresses as these cells form tumors that can grow within or around the digestive organs.

Advanced Solid Tumors With HIF-2α related Genetic Alterations – This refers to various types of solid cancers that have specific changes in the HIF-2α gene. These genetic changes influence how cells respond to low oxygen levels. The disease progresses as these altered cells grow and form solid masses in the body.

Trial ID:
2025-524160-38-00
Protocol code:
MK-6482-043
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Ifinatamab deruxtecan in Patients With Advanced Esophageal Squamous Cell Carcinoma

    Recruiting

    2 1 1
    Investigated drugs:
    Czechia France Germany Norway
  • Belzutifan and Zanzalintinib in Adults with Advanced Renal Cell Carcinoma After PD-1/L1 and VEGF-TKI Therapy

    Recruiting

    3 1 1
    Czechia Denmark France Germany Greece Italy +3