Active not recruitingPHASE3INTERVENTIONAL

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

This study is looking at a new medication called belzutifan for people with advanced kidney cancer (renal cell carcinoma). It compares belzutifan to an existing treatment, everolimus. The main goal is to see if belzutifan can keep the cancer from getting worse for a longer time and potentially help people live longer compared to everolimus. Participants in this study will have kidney cancer that has continued to grow even after trying at least two other types of treatment. Researchers believe belzutifan might be better than everolimus at controlling the cancer. This is a Phase 3 study, meaning it's one of the final steps before a new drug might be approved for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

755

Start

27 Feb 2020

Estimated completion

17 Sep 2026

Carcinoma, Renal Cell

Results

Results from this study

Posted April 2025

Results have been published for this study.

Primary outcome

Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review is presented here.

Full results on the registry

What is this study about?

This study is designed for individuals living with advanced kidney cancer. Kidney cancer is also known as renal cell carcinoma. We are investigating a new drug called belzutifan and comparing it to a drug that is already in use, called everolimus. The main purpose of this research is to find out if belzutifan can prevent the cancer from growing or spreading for a longer period of time compared to everolimus. We also want to see if belzutifan helps people live longer.

You might be familiar with the term 'clinical trial'. This is a Phase 3 study, which means it’s one of the final stages of testing a new medicine before it can be made available to more people. In this particular study, doctors will carefully track how well each drug works by regularly checking the size of the cancer. An independent group of experts will review these scans to make sure the results are fair and accurate. The hope is that belzutifan will prove to be more effective than everolimus in these key areas.

It's important to understand that this study is for people whose kidney cancer has progressed, or continued to grow, even after they have received at least two specific types of treatment already. These previous treatments include a 'PD-1/L1 checkpoint inhibitor' and a 'VEGF-TKI'. Both of these are types of medicines used to fight cancer. The study is particularly interested in people who have had these treatments but their cancer has still progressed.

Key takeaways

This study is for advanced kidney cancer.
It compares a new drug (belzutifan) to an existing one (everolimus).
It aims to see if the new drug stops cancer growth longer and helps people live longer.
You must have tried at least two other specific treatments already for your kidney cancer.
Participation involves regular hospital visits, tests, and taking study medication.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to have advanced kidney cancer that doctors cannot remove with surgery. Your cancer must also have continued to grow despite having received two specific types of treatment beforehand. You should not have received more than three different treatments for your advanced kidney cancer in total.

You would need to be at least 18 years old. Both men and women can take part. Women who could become pregnant would need to use reliable birth control during the study and for a period afterwards. Men would also need to use contraception if they are sexually active during the study and for a short time after. You would also need to be generally well enough to take part and have your organs working properly.

There are also some reasons why you might not be able to join. For example, if you have certain other cancers that are active or have needed recent treatment. If your cancer has spread to your brain or spinal cord, you might also not be able to participate, unless it has been successfully treated and stable for a while.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have advanced kidney cancer that can't be removed by surgery?
Has my cancer continued to grow after trying both a PD-1/L1 inhibitor and a VEGF-TKI treatment?
Have I had no more than three previous treatments for my advanced kidney cancer?
Am I at least 18 years old?
Do I have overall good health, and are my organs working well?
Do I understand and agree to use contraception if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new drug, belzutifan, or the existing drug, everolimus. You would have regular appointments for check-ups, blood tests, and scans to see how your cancer is responding to the treatment. These assessments are done to monitor your health and the effects of the medication.

You would take the study medication as prescribed for a certain period. The exact number of visits and the duration of the study medication treatment would be explained to you in detail by the study team. There will also be a follow-up period after you stop taking the study drug to continue monitoring your health. The total time you would be involved in the study, including treatment and follow-up, would depend on your individual response and progress.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new experimental treatment (belzutifan) before it's widely available, which might be more effective than current options. You would also receive close medical attention and monitoring. However, there are potential risks, as with any medication. Belzutifan might have side effects that are not yet fully known or can be uncomfortable. Everolimus also has known side effects which would be discussed. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (172)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Faculty Office Towers 1132 ( Site 1538)
Verified postcode
Birmingham, United States
University of California San Diego Moores Cancer Center ( Site 1546)
Verified postcode
La Jolla, United States
St. Joseph Heritage Healthcare Local Lab ( Site 1531)
Verified postcode
Santa Rosa, United States
University of Colorado Cancer Center ( Site 1540)
Verified postcode
Aurora, United States
UCHealth Highlands Ranch Hospital ( Site 1560)
Verified postcode
Highlands Ranch, United States
Sibley Memorial Hospital ( Site 1559)
Verified postcode
Washington D.C., United States
Northwest Georgia Oncology Centers PC ( Site 1520)
Verified postcode
Marietta, United States
The University of Chicago Medical Center ( Site 1539)
Verified postcode
Chicago, United States
Ochsner Medical Center ( Site 1522)
Verified postcode
New Orleans, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514)
Verified postcode
Baltimore, United States
Massachusetts General Hospital ( Site 1558)
Verified postcode
Boston, United States
Beth Israel Deaconess Medical Center ( Site 1501)
Verified postcode
Boston, United States

Common questions

What kind of kidney cancer is this study for?

This study is for advanced clear cell kidney cancer that doctors cannot remove with surgery.

What drugs are being tested?

The study compares a new drug called belzutifan with an existing drug called everolimus.

Have I had to have previous treatments for my kidney cancer?

Yes, your cancer must have progressed after trying two specific types of prior treatments.

How long will the study last?

The exact duration will depend on your individual response, including treatment time and follow-up.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect your regular medical care.