RecruitingPHASE3INTERVENTIONAL

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

This study is for adults with advanced kidney cancer (renal cell carcinoma) that has returned after previous treatment. Doctors are looking for new and more effective ways to help patients in this situation. The main goal is to find out if a new combination of medicines, called belzutifan and zanzalintinib, can help people live longer and keep their cancer from getting worse, compared to a widely used medicine called cabozantinib. Participants will be given either the new combination or cabozantinib. This is a Phase 3 study, which means these medicines have already been tested, and now researchers want to compare them to an existing treatment to see if they are better.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

904

Start

26 Nov 2025

Estimated completion

27 Feb 2032

Renal Cell Carcinoma

What is this study about?

If you or someone you know has advanced kidney cancer that has come back after treatment, you might be interested to know about a new research study. This study is exploring a new way to treat kidney cancer, also known as renal cell carcinoma, when it has progressed or returned after earlier treatment. Doctors are always trying to find new and more effective treatments for cancer, and this study aims to see if a new approach can make a difference for patients.

The study wants to find out if two medicines, belzutifan and zanzalintinib, when given together, are more effective than a standard treatment called cabozantinib. 'Effective' in this case means seeing if the cancer shrinks or stops growing, and if people live longer or without their cancer getting worse for a longer period of time. Cabozantinib is already known to help people with kidney cancer, so researchers are keen to see if this new combination could offer an even better option.

By comparing these treatments, the researchers hope to gather important information that could lead to new ways to care for people with advanced kidney cancer. Taking part in a study like this helps improve our understanding of cancer and can lead to better treatments for patients in the future.

Key takeaways

New study for adults with advanced kidney cancer that has returned.
Comparing a new combination treatment to a standard cancer medicine.
Aims to find out if the new combination can help people live longer.
Involves regular clinic visits and health monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have advanced kidney cancer that has returned. Your cancer must be a specific type called 'clear cell' and it should have spread or come back after you've had a certain type of immunotherapy treatment (called anti-PD-1/L1 therapy). Importantly, you shouldn't have received any other cancer treatments for your kidney cancer besides that immunotherapy.

There are also some reasons why you might not be able to join. For example, if you've had certain heart problems, a recent blood clot, or major surgery within the last eight weeks. They will also check if you have certain lung or stomach issues. These rules are in place to make sure that the study is as safe as possible for everyone involved.

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.

Are you 18 years old or older?
Do you have a clear cell type of advanced kidney cancer that has returned?
Did your cancer return during or within 24 months after a specific immunotherapy treatment (anti-PD-1/L1 therapy)?
Have you had no other cancer treatment for your kidney cancer apart from that immunotherapy?
Have you not had certain heart problems or major surgery recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new combination of belzutifan and zanzalintinib, or the standard treatment cabozantinib. This is like flipping a coin – neither you nor your doctor can choose which treatment you get. You would have regular visits to the clinic for check-ups, assessments, and to receive your medication. These visits would involve various tests to monitor your health and how your cancer is responding to treatment. The study will continue for as long as the treatment is helping you and you are able to tolerate it, followed by a period of follow-up where doctors will continue to monitor your health. The total time you'll be involved varies depending on how you respond to treatment.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment that could be more effective for your kidney cancer than existing options. However, there's no guarantee that the treatment will work for you, and it might not be better than standard care. All medicines can have side effects, and you might experience side effects from the study drugs. Researchers will closely monitor your health to identify and manage any side effects. You are always in control and have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (108)

Hospital Aleman ( Site 0204)
City only
CABA, Argentina· Recruiting
Hospital Italiano de Buenos Aires. ( Site 0203)
City only
Caba, Argentina· Recruiting
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)
City only
Caba, Argentina· Recruiting
Instituto Alexander Fleming ( Site 0202)
City only
CABA, Argentina· Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0208)
City only
Caba., Argentina· Recruiting
Sanatorio Parque ( Site 0201)
Verified postcode
Rosario, Argentina· Recruiting
Instituto de Oncología de Rosario ( Site 0209)
Verified postcode
Rosario, Argentina· Recruiting
Hospital Privado Universitario de Córdoba ( Site 0207)
Verified postcode
Córdoba, Argentina· Recruiting
Macquarie University-MQ Health Clinical Trials Unit ( Site 2100)
Verified postcode
Sydney, Australia· Recruiting
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600)
Verified postcode
Linz, Austria· Recruiting
Medizinische Universitat Wien ( Site 0601)
Verified postcode
Vienna, Austria· Recruiting
Cliniques Universitaires Saint-Luc ( Site 0703)
Verified postcode
Brussels, Belgium· Recruiting

Common questions

What is 'advanced kidney cancer'?

This means the kidney cancer has spread to other parts of the body or has returned after initial treatment.

What does 'recurrent' mean?

It means the cancer has come back after it was previously treated.

What are belzutifan, zanzalintinib, and cabozantinib?

These are names of medicines used to treat cancer. Belzutifan and zanzalintinib are being tested together, and cabozantinib is a standard treatment.

What does 'Phase 3' mean for a study?

Phase 3 means the treatment has already shown promise in earlier tests, and now researchers are comparing it to existing treatments to see if it's better.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of the treatment groups, like drawing lots, and neither you nor your doctor will usually know which one it is.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.