RecruitingPHASE3INTERVENTIONAL

A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)

Doctors are always looking for better ways to treat advanced kidney cancer. One standard treatment uses a medicine called belzutifan, which is a "targeted therapy." This type of therapy works by focusing on specific ways cancer cells grow and spread. This study is testing if adding another targeted therapy, zanzalintinib, to belzutifan works better than belzutifan alone. The main goal is to find out if people who get both medicines live longer and if their cancer is controlled for a longer time compared to those who just get belzutifan plus a dummy medicine (placebo). This research could help more patients with advanced kidney cancer in the future.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

758

Start

09 Apr 2026

Estimated completion

27 Nov 2030

Carcinoma, Renal Cell

What is this study about?

This study is about finding new and more effective treatments for advanced kidney cancer, specifically a type called renal cell carcinoma (RCC). Advanced means the cancer has spread from where it started.

Currently, a common treatment for some people with this type of kidney cancer is a medicine called belzutifan. Belzutifan is a "targeted therapy," which means it works by focusing on certain features of cancer cells to stop them from growing and spreading. Researchers are exploring if adding another targeted therapy, called zanzalintinib, to belzutifan could provide an even better treatment. The hope is that the combination might work for more people or be more effective than belzutifan on its own.

The main aim of this study is to compare the combination of belzutifan and zanzalintinib with belzutifan alone. By doing this, doctors want to see if the two medicines together can help people live longer and prevent the cancer from getting worse for a longer period of time. People in the study will either receive both belzutifan and zanzalintinib, or belzutifan alongside a placebo (a dummy medicine that looks like zanzalintinib but has no active ingredients).

Key takeaways

This study is for people with advanced kidney cancer.
It tests a new combination of two targeted therapies: belzutifan and zanzalintinib.
The goal is to see if the combination is better than belzutifan alone for controlling cancer and helping people live longer.
Participation involves regular hospital visits, medicines, blood tests, and scans.
You might receive the new combination or belzutifan with a dummy medicine.
It's a Phase 3 study, meaning these treatments have been tested before in smaller groups.

Who may be eligible?

To join this study, people generally need to have advanced kidney cancer (renal cell carcinoma) that doctors can measure. This cancer must have specific features under the microscope. You might be considered if your cancer hasn't been removed by surgery and is considered advanced.

There are also some rules about past treatments. For example, you can't have had too many previous treatments for your kidney cancer. Specifically, you shouldn't have had more than three types of full-body treatments for your kidney cancer, and only one of these can be a specific type of immunotherapy (a treatment that helps your immune system fight cancer).

However, there are also reasons why someone might not be able to join. For instance, if you have certain heart problems, lung conditions like ongoing breathing difficulties or a history of specific lung diseases, or if you've had major surgery very recently, you might not be eligible. People with certain infections like HIV or Hepatitis B or C, or if they've had another cancer recently that's getting worse, usually cannot take part.

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 (renal cell carcinoma)?
Has my cancer spread but is still measurable?
Have I had three or fewer previous full-body treatments for my kidney cancer?
Have I only had one specific type of immunotherapy (PD-1/PD-L1 therapy) in the past?
Do I have any serious heart conditions or ongoing lung problems?
Have I had major surgery very recently (within the last 8 weeks)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given either a combination of two study medicines (belzutifan and zanzalintinib) or belzutifan plus a dummy medicine (placebo). This will be decided randomly, like flipping a coin. You'll have regular hospital visits for check-ups, where doctors will monitor your health, perform blood tests, and do scans to see how your cancer is responding. These visits will be needed throughout the treatment period. The total length of your participation will depend on how you respond to the treatment and your overall health. You'll also have follow-up appointments after your main treatment has finished to continue monitoring your health and the cancer.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as access to new treatments before they are widely available, and close medical monitoring. However, there are also potential risks, as the study medicines could cause side effects, which the medical team will explain to you. It's important to remember that the medicines might not help everyone. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (59)

Centro Oncologico Korben ( Site 0254)
City only
CABA, Argentina· Recruiting
Hospital Italiano de Buenos Aires ( Site 0253)
City only
Ciudad de Buenos Aires, Argentina· Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)
Verified postcode
Mar del Plata, Argentina· Recruiting
Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)
Verified postcode
Río Cuarto, Argentina· Recruiting
Sanatorio Parque ( Site 0251)
Verified postcode
Rosario, Argentina· Recruiting
Instituto de Oncología de Rosario ( Site 0257)
Verified postcode
Rosario, Argentina· Recruiting
Instituto Alexander Fleming ( Site 0252)
City only
CABA, Argentina· Recruiting
Centro Oncológico Riojano Integral ( Site 0256)
Verified postcode
La Rioja, Argentina· Recruiting
COE (Centro Oncológico de Excelencia) ( Site 0259)
Verified postcode
San Juan, Argentina· Recruiting
Macquarie University ( Site 2700)
City only
Macquarie University, Australia· Suspended
Instituto do Câncer e Transplante de Curitiba ( Site 0300)
Verified postcode
Curitiba, Brazil· Recruiting
Masarykuv onkologicky ustav ( Site 0903)
Verified postcode
Brno, Czechia· Recruiting

Common questions

What is renal cell carcinoma?

It's a common type of kidney cancer that starts in the small tubes of the kidney.

What does 'targeted therapy' mean?

It's a type of cancer treatment that focuses on specific differences between cancer cells and normal cells to stop the cancer from growing.

Will I definitely get the new combination treatment?

Not necessarily. Participants are randomly assigned to one of two treatment groups, meaning some will get the combination and others will get belzutifan plus a dummy medicine.

What is a 'placebo'?

A placebo is an inactive substance, sometimes called a dummy medicine, that looks exactly like the study drug but contains no active ingredient.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, for any reason, without it affecting your current or future medical care.

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.