Not recruiting

Study of Belzutifan for Patients with Advanced Kidney Cancer

Fast replyInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Advanced Renal Cell Carcinoma, which is a type of kidney cancer that has spread beyond the kidney. The trial is testing a new treatment called Belzutifan, also known by its code name MK-6482. This medication is taken as a film-coated tablet and is being evaluated to see how effective it is in treating this type of cancer.

The purpose of the study is to compare two different doses of Belzutifan—120 mg and 200 mg—to determine which dose is more effective. Participants in the study will receive one of these doses daily. The study will monitor how well the cancer responds to the treatment and how long the effects last. It will also track the overall health and survival of the participants, as well as any side effects they may experience.

Throughout the study, participants will be regularly assessed to see how their cancer is responding to the treatment. This will involve various tests and evaluations to ensure the safety and effectiveness of the medication. The study aims to provide valuable information that could lead to new treatment options for people with advanced kidney cancer.

The research process

The trial runs in 6 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 participant will be informed about the trial's purpose and procedures. The study focuses on comparing two doses of an experimental drug called belzutifan for treating advanced renal cell carcinoma.
Step 2
Medication administration
Participants will receive belzutifan in the form of a film-coated tablet. The medication is taken orally once daily.
Two different doses are being compared: 120 mg and 200 mg. The specific dose assigned will be communicated to the participant.
Step 3
Treatment duration
The treatment will continue as long as it is beneficial and no significant side effects occur. Regular assessments will determine the effectiveness and safety of the treatment.
Step 4
Regular assessments
Participants will undergo regular assessments to monitor the response to the treatment. These assessments will follow specific criteria to evaluate the tumor's response.
The assessments will be conducted by an independent review team to ensure unbiased results.
Step 5
Monitoring side effects
Participants will be monitored for any side effects throughout the study. Any adverse effects will be documented, and the treatment may be adjusted if necessary.
Step 6
Study completion
The study is expected to conclude by January 16, 2026. Participants will be informed about the study's findings and any further steps if applicable.

Who can join the trial?

6 criteria

The patient must have a confirmed diagnosis of **advanced renal cell carcinoma**. This is a type of kidney cancer that has spread beyond the kidney.
The patient must be able to provide a sample of their tumor tissue. This can be an old sample or a new one from a biopsy, which is a procedure to remove a small piece of tissue for testing.
The patient must have experienced disease progression, meaning the cancer has gotten worse, after receiving treatment with a specific type of therapy called **anti-PD-1/L1 therapy**. This is a treatment that helps the immune system fight cancer.
The patient must not have received more than three different treatments for their advanced kidney cancer.
The patient must have recovered from any side effects of previous treatments to a mild level, except for certain nerve-related or hormone-related side effects that are still manageable.
Both male and female patients are eligible to participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

MK-6482: This is an investigational medication being studied for its potential to treat advanced renal cell carcinoma, a type of kidney cancer. The trial aims to evaluate how effective this medication is in shrinking tumors or stopping their growth. Participants in the study receive this medication to see if it can improve their condition compared to other treatments.

Belzutifan

What is already known about the treatment

Belzutifan – Belzutifan is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating advanced renal cell carcinoma, a type of kidney cancer. The medication works by inhibiting a protein called HIF-2α, which is involved in the growth of cancer cells. By blocking this protein, belzutifan may help slow down or stop the progression of the cancer. It is classified as a targeted cancer therapy, focusing on specific molecules involved in cancer growth.

Investigated diseases

Advanced Renal Cell Carcinoma – This is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It is considered advanced when it has spread beyond the kidney to other parts of the body. The disease often progresses by forming tumors that can grow and invade nearby tissues or spread to distant organs. Symptoms may include blood in the urine, pain in the side or back, and a mass in the abdomen. As the disease advances, it can lead to fatigue, weight loss, and fever. The progression of the disease can vary, with some tumors growing slowly while others may spread more rapidly.