Not recruitingRare disease

Study on Belzutifan for Treating Kidney Cancer in Patients with von Hippel-Lindau Disease

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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 a condition known as von Hippel-Lindau disease-associated kidney cancer. This is a rare genetic disorder that can lead to the development of tumors in various parts of the body, including the kidneys. The trial is testing a medication called Belzutifan, also known by its code name MK-6482. This medication is taken orally in the form of a film-coated tablet.

The purpose of the study is to evaluate how effective Belzutifan is in treating kidney cancer associated with von Hippel-Lindau disease. Participants in the study will take the medication and be monitored over a period of time to see how their cancer responds. The study will look at various outcomes, such as how long the response to the treatment lasts and how quickly the treatment starts to work. The study will also track the time until any necessary surgery is performed and will evaluate the medication's behavior in the body.

Participants will be required to take the medication as directed and attend regular check-ups to monitor their health and the progress of the treatment. The study aims to provide valuable information on the potential benefits of Belzutifan for individuals with von Hippel-Lindau disease-associated kidney cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will begin by providing informed consent, confirming understanding and willingness to participate.
Eligibility is confirmed based on criteria such as age, diagnosis of von Hippel-Lindau disease, and ability to swallow oral medications.
Step 2
Medication administration
The patient will receive the medication Belzutifan, which is a film-coated tablet taken orally.
The dosage and frequency of administration will be determined by the study protocol and communicated to the patient by the study team.
Step 3
Monitoring and assessments
Regular monitoring will occur to assess the patient's response to the treatment. This includes evaluating the size and progression of tumors using specific criteria.
The patient's overall response rate, duration of response, and progression-free survival will be measured.
Step 4
Follow-up and conclusion
The study is estimated to conclude by December 30, 2026. During this time, the patient will continue to be monitored for any changes in their condition.
Upon completion of the study, final assessments will be conducted to evaluate the overall effectiveness of the treatment.

Who can join the trial?

9 criteria

The patient must be able to understand and willing to sign a document that shows they agree to participate in the study.
The patient must be 18 years of age or older.
The patient must have a diagnosis of **von Hippel-Lindau disease**, which is a genetic condition.
The patient must have at least one measurable solid **Renal Cell Carcinoma (RCC)** tumor, which is a type of kidney cancer, and no RCC tumor larger than 3.0 cm that needs immediate surgery. The diagnosis can be made using imaging tests, and a tissue sample is not required. Patients may have tumors related to von Hippel-Lindau disease in other parts of the body.
The patient must have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 to 1, which means they are fully active or have some symptoms but do not need to stay in bed.
The patient must have proper organ and bone marrow function as defined in the study protocol.
Male patients must agree to either abstain from heterosexual intercourse or use contraception during the study and for at least 7 days after the last dose. If they have a pregnant or breastfeeding partner, they must agree to use a condom or abstain from intercourse.
Female patients must not be pregnant or breastfeeding. If they are of childbearing potential, they must use a highly effective method of contraception or abstain from heterosexual intercourse during the study and for at least 30 days after the last dose. They must also have a negative pregnancy test before starting the study.
The patient must be able to swallow oral medications and follow the study procedures.

Who cannot join the trial?

5 criteria

Patients who do not have **Von Hippel-Lindau disease-associated Renal Cell Carcinoma** cannot participate. This is a specific type of kidney cancer linked to a genetic condition called Von Hippel-Lindau disease.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for people with certain characteristics or conditions.
Both **female** and **male** patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a **vulnerable population** may be excluded. This term refers to groups of people who might need special protection or consideration in research, such as children, pregnant women, or those with certain disabilities.

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Verified sites

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Aarhus University Hospital
Aarhus, Denmark
Verified
Hopital Beaujon
Clichy, France

Trial locations

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Investigated drugs

PT2977 (belzutifan) is being studied for its effectiveness in treating renal cell carcinoma associated with von Hippel-Lindau disease. This medication is being evaluated to see how well it can reduce the size of tumors or stop them from growing, as assessed by specific criteria used to measure tumor response.

Belzutifan

What is already known about the treatment

Belzutifan – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating renal cell carcinoma associated with Von Hippel-Lindau disease. It is in the investigational stage, with ongoing research to determine its efficacy and safety. The main therapeutic indication is for patients with Von Hippel-Lindau disease who develop renal cell carcinoma. Belzutifan works by inhibiting a protein called hypoxia-inducible factor-2 alpha (HIF-2α), which plays a role in tumor growth and survival. It is classified as a targeted cancer therapy, focusing on specific molecular targets associated with cancer progression.

Investigated diseases

Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma – This is a type of kidney cancer that occurs in individuals with Von Hippel-Lindau disease, a genetic disorder. The disease is characterized by the development of tumors and cysts in different parts of the body, including the kidneys. In the case of renal cell carcinoma associated with this condition, tumors form in the kidney's lining of the small tubes. These tumors can grow and potentially spread to other parts of the body. The progression of the disease can vary, with some tumors remaining stable for long periods, while others may grow more rapidly. The condition is considered rare and is part of a broader spectrum of manifestations associated with Von Hippel-Lindau disease.