Study of Belzutifan for Patients with Advanced Kidney Cancer

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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.

Who Cannot Join the Study?

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

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Alexandra Hospital	Athens	Greece
Netherlands Cancer Institute	Amsterdam	The Netherlands
Universitair Ziekenhuis Gent	Gent	Belgium
Isala Klinieken Stichting	Zwolle	The Netherlands
Enpvcgl Uzgtvhabolta Mtzgiuf Cqifhsj Rvotbaxsx (slmbddx Mgn	Rotterdam	The Netherlands
Czxr Ukojqggkdy Hoafirlx	Cork	Ireland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	08.12.2020
Greece	Not recruiting	08.12.2020
Ireland	Not recruiting	08.12.2020
The Netherlands	Not recruiting	08.12.2020

Trial locations

Investigated drugs:

Belzutifan

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.

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.

Trial ID:

2022-502123-21-00

Protocol code:

MK-6482-013

NCT ID:

NCT04489771

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Belzutifan for Patients with Advanced Kidney Cancer

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